21 C.F.R. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Title 21 - Food and Drugs
Title 21: Food and Drugs
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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Section Contents
Subpart A—General Provisions
§ 558.3 Definitions and general considerations applicable to this part.
§ 558.4 Requirement of a medicated feed mill license.
§ 558.5 Requirements for liquid medicated feed.
§ 558.6 Veterinary feed directive drugs.
§ 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.35 Aklomide.
§ 558.55 Amprolium.
§ 558.58 Amprolium and ethopabate.
§ 558.59 Apramycin.
§ 558.60 Arsanilate sodium.
§ 558.62 Arsanilic acid.
§ 558.76 Bacitracin methylene disalicylate.
§ 558.78 Bacitracin zinc.
§ 558.95 Bambermycins.
§ 558.105 [Reserved]
§ 558.115 Carbadox.
§ 558.120 Carbarsone (not U.S.P.).
§ 558.128 Chlortetracycline.
§ 558.140 Chlortetracycline and sulfamethazine.
§ 558.145 Chlortetracycline, procaine penicillin, and sulfamethazine.
§ 558.155 Chlortetracycline, sulfathiazole, penicillin.
§ 558.175 Clopidol.
§ 558.185 Coumaphos.
§ 558.195 Decoquinate.
§ 558.198 Diclazuril.
§ 558.205 Dichlorvos.
§ 558.235 Efrotomycin.
§ 558.248 Erythromycin thiocyanate.
§ 558.254 Famphur.
§ 558.258 Fenbendazole.
§ 558.261 Florfenicol.
§ 558.265 Halofuginone hydrobromide.
§ 558.274 Hygromycin B.
§ 558.295 Iodinated casein.
§ 558.300 Ivermectin.
§ 558.305 Laidlomycin.
§ 558.311 Lasalocid.
§ 558.315 Levamisole hydrochloride (equivalent).
§ 558.325 Lincomycin.
§ 558.340 Maduramicin ammonium.
§ 558.342 Melengestrol.
§ 558.348 Mibolerone.
§ 558.355 Monensin.
§ 558.360 Morantel tartrate.
§ 558.363 Narasin.
§ 558.364 Neomycin sulfate.
§ 558.365 Nequinate.
§ 558.366 Nicarbazin.
§ 558.369 Nitarsone.
§ 558.376 Nitromide and sulfanitran.
§ 558.415 Novobiocin.
§ 558.430 Nystatin.
§ 558.435 Oleandomycin.
§ 558.450 Oxytetracycline.
§ 558.455 Oxytetracycline and neomycin.
§ 558.460 Penicillin.
§ 558.464 Poloxalene.
§ 558.465 Poloxalene free-choice liquid Type C feed.
§ 558.485 Pyrantel tartrate.
§ 558.500 Ractopamine.
§ 558.515 Robenidine hydrochloride.
§ 558.530 Roxarsone.
§ 558.550 Salinomycin.
§ 558.555 Semduramicin.
§ 558.575 Sulfadimethoxine, ormetoprim.
§ 558.579 Sulfaethoxypyridazine.
§ 558.582 Sulfamerazine.
§ 558.586 Sulfaquinoxaline.
§ 558.600 Tiamulin.
§ 558.615 Thiabendazole.
§ 558.618 Tilmicosin.
§ 558.625 Tylosin.
§ 558.630 Tylosin and sulfamethazine.
§ 558.635 Virginiamycin.
§ 558.680 Zoalene.
Authority: 21 U.S.C. 360b, 371.
Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.
Subpart A—General Provisions
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§ 558.3 Definitions and general considerations applicable to this part.
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(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is not approved.
(b) The following definitions apply to terms used in this part:
(1) New animal drugs approved for use in animal feed are placed in two categories as follows:
(i) Category I—These drugs require no withdrawal period at the lowest use level in each species for which they are approved.
(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required, or are a veterinary feed directive drug.
(2) A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A medicated article requires an application approved under §514.105 of this chapter.
(3) A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term “highest continuous use level” means the highest dosage at which the drug is approved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the highest level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The manufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under §515.20 of this chapter.
(4) A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” (added on top of usual ration) on or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed. The manufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under §515.20 of this chapter.
(5) A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under §514.105 of this chapter.
(6) A “veterinary feed directive (VFD) drug” is a new animal drug approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (the act) for use in or on animal feed. Use of a VFD drug must be under the professional supervision of a licensed veterinarian.
(7) A “veterinary feed directive” is a written statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a veterinary feed directive (VFD) drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use the VFD drug in or on an animal feed to treat the client's animals only in accordance with the directions for use approved by the Food and Drug Administration (FDA). A veterinarian may issue a VFD only if a valid veterinarian-client-patient relationship exists, as defined in §530.3(i) of this chapter.
(8) A “medicated feed” means a Type B medicated feed as defined in paragraph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section.
(9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another distributor or to the client-recipient of the VFD.
(10) An “animal production facility” is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made.
(11) An “acknowledgment letter” is a written communication provided to a distributor by a consignee who is not the ultimate user of medicated feed containing a VFD drug. An acknowledgment letter affirms that the consignee will not ship such medicated animal feed to an animal production facility that does not have a VFD, and will not ship such feed to another distributor without receiving a similar written acknowledgment letter.
[51 FR 7392, Mar. 3, 1986, as amended at 52 FR 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, 1999; 65 FR 76929, Dec. 8, 2000]
§ 558.4 Requirement of a medicated feed mill license.
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(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.
(b) The manufacture of the following types of feed are exempt from the required license, unless otherwise specified:
(1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and
(2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.
(c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part and in §558.15 of this chapter.
(d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows:
Category I---------------------------------------------------------------------------------------------------------------- Assay limits Assay limits percent \1\ type Drug percent \1\ Type B maximum (200x) B/C \2\ type A----------------------------------------------------------------------------------------------------------------Aklomide............................... 90-110 22.75 g/lb (5.0%)......... 85-120.Amprolium with Ethopabate.............. 94-114 22.75 g/lb (5.0%)......... 80-120.Bacitracin methylene disalicylate...... 85-115 25.0 g/lb (5.5%).......... 70-130.Bacitracin zinc........................ 84-115 5.0 g/lb (1.1%)........... 70-130.Bambermycins........................... 90-110 800 g/ton (0.09%)......... 80-120/70-130.Buquinolate............................ 90-110 9.8 g/lb (2.2%)........... 80-120.Chlortetracycline...................... 85-115 40.0 g/lb (8.8%).......... 80-115/70-130.Coumaphos.............................. 95-115 6.0 g/lb (1.3%)........... 80-120.Decoquinate............................ 90-105 2.72 g/lb (0.6%).......... 80-120.Dichlorvos............................. 100-115 33.0 g/lb (7.3%).......... 90-120/80-130.Diclazuril............................. 90-110 182 g/t (0.02%)........... 85-115/70-120.Efrotomycin............................ 94-113 1.45 g/lb (0.32%)......... 80-120.Erythromycin (thiocyanate salt)........ 85-115 9.25 g/lb (2.04%)......... <20g/ton 70-115/150- 50:>20g/ton 75-125.Iodinated casein....................... 85-115 20.0 g/lb (4.4%).......... 75-125.Laidlomycin propionate potassium....... 90-110 1 g/lb (0.22%)............ 90-115/85-115.Lasalocid.............................. 95-115 40.0 g/lb (8.8%).......... Type B (cattle and sheep): 80- 120; Type C (all): 75-125.Lincomycin............................. 90-115 20.0 g/lb (4.4%).......... 80-130.Melengestrol acetate................... 90-110 10.0 g/ton (0.0011%)...... 70-120.Monensin............................... 85-115 40.0 g/lb (8.8%).......... Chickens, turkeys, and quail: 75-125; Cattle: 5-10 g/ton 80- 120; Cattle: 10-30 g/ton 85- 115; Goats: 20 g/ton 85-115; Liq. feed: 80-120.Narasin................................ 90-110 7.2 g/lb (1.6%)........... 85-115/75-125.Nequinate.............................. 95-112 1.83 g/lb (0.4%).......... 80-120.Niclosamide............................ 85-120 225g/lb (49.5%)........... 80-120.Nystatin............................... 85-125 5.0 g/lb (1.1%)........... 75-125.Oleandomycin........................... 85-120 1.125 g/lb (0.25%)........ <11.25 g/ton 70-130; >11.25 g/ton 75-125.Oxytetracycline........................ 90-120 20.0 g/lb (4.4%).......... 75-125/65-135.Penicillin............................. 80-120 10.0 g/lb (2.2%).......... 65-135.Poloxalene............................. 90-110 54.48 g/lb (12.0%)........ Liq. feed: 85-115.Ractopamine............................ 85-105 2.46 g/lb (0.54%)......... 80-110/75-125.Salinomycin............................ 95-115 6.0 g/lb (1.3%)........... 80-120.Semduramicin........................... 90-110 2.25 g/lb (0.50%)......... 80-110.Tiamulin............................... 113.4 g/lb, 3.5 g/lb (0.8%)........... 90-115. 100-108 5 and 10 g/ .......................... 70-130. 1b, 90-115Tylosin................................ 80-120 10.0 g/lb (2.2%).......... 75-125.Virginiamycin.......................... 85-115 10.0 g/lb (2.2%).......... 70-130.Zoalene................................ 92-104 11.35 g/lb (2.5%)......... 85-115.----------------------------------------------------------------------------------------------------------------\1\ Percent of labeled amount.\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.
Category II---------------------------------------------------------------------------------------------------------------- Assay limits Assay limits percent \1\ Type Drug percent \1\ Type B maximum (100x) B/C \2\ Type A----------------------------------------------------------------------------------------------------------------Amprolium.............................. 94-114 11.35 g/lb (2.5%)......... 80-120.Apramycin.............................. 88-112 7.5 g/lb (1.65%).......... 80-120.Arsanilate sodium...................... 90-110 4.5 g/lb (1.0%)........... 85-115/75-125.Arsanilic acid......................... 90-110 4.5 g/lb (1.0%)........... 85-115/75-125.Carbadox............................... 90-110 2.5 g/lb (0.55%).......... 75-125.Carbarsone............................. 93-102 17.0 g/lb (3.74%)......... 85-115.Clopidol............................... 94-106 11.4 g/lb (2.5%).......... 90-115/80-120.Famphur................................ 100-110 5.5 g/lb (1.21%).......... 90-115/80-120.Fenbendazole........................... 93-113 8.87 g/lb (1.96%)......... 75-125Florfenicol............................ 90-110 n/a....................... 80-110Halofuginone hydrobromide.............. 90-115 272.0 g/ton (.03%)........ 75-125.Hygromycin B........................... 90-110 1,200 g/ton (0.13%)....... 75-125.Ivermectin............................. 95-105 1,180 g/ton (0.13%)....... 80-110.Levamisole............................. 85-120 113.5 g/lb (25%).......... 85-125.Maduramicin ammonium................... 90-110 545 g/ton (.06%).......... 80-120.Morantel tartrate...................... 90-110 66.0 g/lb (14.52%)........ 85-115.Neomycin............................... 80-120 7.0 g/lb (1.54%).......... 70-125. Oxytetracycline...................... 80-120 10.0 g/lb (2.2%).......... 65-135.Neomycin sulfate....................... 80-120 100 g/lb (22.0%).......... 70-125.Nicarbazin (granular).................. 90-110 5.675 g/lb (1.25%)........ 85-115/75-125 Narasin.............................. 90-110 5.675 g/lb (1.25%)........ 85-115/75-125Nicarbazin (powder).................... 98-106 5.675 g/lb (1.25%)........ 85-115/80-120Nitarsone.............................. 90-110 8.5 g/lb (1.87%).......... 85-120.Nitromide.............................. 90-110 11.35 g/lb (2.5%)......... 80-120. Sulfanitran.......................... 85-115 13.6 g/lb (3.0%).......... 75-125.Nitromide.............................. 90-110 11.35 g/lb (2.5%)......... 85-115. Sulfanitran.......................... 85-115 5.65 g/lb (1.24%)......... 75-125. Roxarsone............................ 90-110 2.275 g/lb (0.5%)......... 85-120.Novobiocin............................. 85-115 17.5 g/lb (3.85%)......... 80-120.Pyrantel tartrate...................... 90-110 36 g/lb (7.9%)............ 75-125.Robenidine............................. 95-115 1.5 g/lb (0.33%).......... 80-120.Ronnel................................. 85-115 27.2 g/lb (6.0%).......... 80-120.Roxarsone.............................. 90-110 2.275 g/lb (0.5%)......... 85-120.Roxarsone.............................. 90-110 2.275 g/lb (0.5%)......... 85-120. Aklomide............................. 90-110 11.35 g/lb (2.5%)......... 85-120.Roxarsone.............................. 90-110 2.275 g/lb (0.5%)......... 85-120. Clopidol............................. 94-106 11.35 g/lb (2.5%)......... 80-120. Bacitracin methylene disalicylate.... 85-115 5.0 g/lb (1.1%)........... 70-130.Roxarsone.............................. 90-110 2.275 g/lb (0.5%)......... 85-120. Monensin............................. 90-110 5.5 g/lb (1.2%)........... 75-125.Sulfadimethoxine....................... 90-110 5.675 g/lb (1.25%)........ 85-115/75-125. Ormetoprim (5/3)..................... 90-110 3.405 g/lb (0.75%)........ 85-115.Sulfadimethoxine....................... 90-110 85.1 g/lb (18.75%)........ 85-115/75-125. Ormetoprim (5/1)..................... 90-110 17.0 g/lb (3.75%)......... 85-115.Sulfaethoxypyridazine.................. 95-105 50.0 g/lb (11.0%)......... 85-115.Sulfamerazine.......................... 85-115 18.6 g/lb (4.0%).......... 85-115.Sulfamethazine......................... 85-115 10.0 g/lb (2.2%).......... 80-120. Chlortetracycline.................... 85-115 10.0 g/lb (2.2%).......... 85-125/70-130. Penicillin........................... 85-115 5.0 g/lb (1.1%)........... 85-125/70-130.Sulfamethazine......................... 85-115 10.0 g/lb (2.2%).......... 80-120. Chlortetracycline.................... 85-115 10.0 g/lb (2.2%).......... 85-125/70-130.Sulfamethazine......................... 85-115 10.0 g/lb (2.2%).......... 80-120. Tylosin.............................. 80-120 10.0 g/lb (2.2%).......... 75-125.Sulfanitran............................ 85-115 13.6 g/lb (3.0%).......... 75-125. Aklomide............................. 90-110 11.2 g/lb (2.5%).......... 85-120.Sulfanitran............................ 85-115 13.6 g/lb (3.0%).......... 75-125. Aklomide............................. 90-110 11.2 g/lb (2.5%).......... 85-120. Roxarsone............................ 90-110 2.715 g/lb (0.60%)........ 85-120.Sulfanitran............................ 85-115 13.6 g/lb (3.0%).......... 75-125. Aklomide............................. 90-110 11.2 g/lb (2.5%).......... 85-120. Roxarsone............................ 90-110 2.27 g/lb (0.5%).......... 85-120.Sulfaquinoxaline....................... 98-106 11.2 g/lb (2.5%).......... 85-115.Sulfathiazole.......................... 85-115 10.0 g/lb (2.2%).......... 80-120. Chlortetracycline.................... 85-125 10.0g/lb (2.2%)........... 70-130. Penicillin........................... 80-120 5.0 g/lb (1.1%)........... 70-130.Thiabendazole.......................... 94-106 45.4 g/lb (10.0%)......... >7% 85-115; <7% 90-110.Tilmicosin............................. 90-110 18.2 g/lb (4.0%).......... 85-115.----------------------------------------------------------------------------------------------------------------\1\ Percent of labeled amount.\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.
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(e) When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product.
[51 FR 7392, Mar. 3, 1986]
Editorial Note: For Federal Register citations affecting §558.4, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.5 Requirements for liquid medicated feed.
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(a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed:
(1) Type B feed that is intended for further manufacture of other medicated feeds (§558.3(b)(3)) or:
(2) Type C feed that is intended for the following:
(i) Further manufacture of another Type C feed, or
(ii) Top-dressing (adding on top of the usual ration) (§558.3(b)(4)).
(b) How is liquid free-choice medicated feed regulated? Liquid free-choice medicated feed is covered by this section and by §510.455.
(c) What types of approvals are required for new animal drugs intended for use in liquid feed? New animal drugs intended for use in liquid feed must be approved for such use under section 512 of the act, as:
(1) An original NADA,
(2) A supplemental NADA, or
(3) An abbreviated NADA.
(d) What are the approval requirements for new animal drugs intended for use in liquid feed? (1) An approval under section 512 of the act is required for any new animal drug intended for use in a liquid feed; and
(2) An approved new animal drug application (NADA) for a drug intended for use in liquid feed must contain the following information:
(i) Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and
(ii) Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or
(iii) Feed labeling with recirculation or agitation directions as follows:
(A) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(B) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(e) How are chemical and physical stability data to be submitted? The data must be submitted as follows:
(1) Directly in the NADA,
(2) By a sponsor, or
(3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.
(f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? The approval of a new animal drug intended for use in liquid feed as published in this subchapter will include the following requirements:
(1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or
(2) A statement that the approval has been granted for a proprietary formula and/or specifications.
(g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds:
(1) All liquid medicated feeds that contain a Category II drug, and
(2) Liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.
(h) What measures are in place to prevent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? Any product containing any form of bacitracin, oxytetracycline, or chlortetracycline, intended for oral administration via animal feed and/or drinking water, and not approved for use in a liquid medicated feed must include in its labeling the following statement: “FOR USE IN ___ ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.” The blank may be filled in with the words: “DRY FEEDS”, “DRINKING WATER”, or “DRY FEEDS AND DRINKING WATER”.
(i) Can the labeling provisions of paragraph (h) of this section be waived, and how can I apply for a waiver? (1) The labeling provisions of paragraph (h) of this section may be waived if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed.
(2) To obtain a waiver, you must submit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV–100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
(3) The letter must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely.
(j) What else do I need to know about the labeling provisions of paragraph (h) of this section? The labeling provisions of paragraph (h) of this section may be implemented without prior approval as provided for in §514.8(d) and (e) of this chapter.
[69 FR 30197, May 27, 2004]
§ 558.6 Veterinary feed directive drugs.
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(a) What conditions must I meet if I am a veterinarian issuing a veterinary feed directive (VFD)?
(1) You must be appropriately licensed.
(2) You must issue a VFD only within the confines of a valid veterinarian-client-patient relationship (see definition at §530.3(i) of this chapter).
(3) You must complete the VFD in writing and sign it or it will be invalid.
(4) You must include all of the following information in the VFD or it will be invalid:
(i) You and your client's name, address and telephone and, if the VFD is faxed, facsimile number.
(ii) Identification and number of animals to be treated/fed the medicated feed, including identification of the species of animals, and the location of the animals.
(iii) Date of treatment, and, if different, date of prescribing the VFD drug.
(iv) Approved indications for use.
(v) Name of the animal drug.
(vi) Level of animal drug in the feed, and the amount of feed required to treat the animals in paragraph (a)(4)(ii) of this section.
(vii) Feeding instructions with the withdrawal time.
(viii) Any special instructions and cautionary statements necessary for use of the drug in conformance with the approval.
(ix) Expiration date of the VFD.
(x) Number of refills (reorders) if necessary and permitted by the approval.
(xi) Your license number and the name of the State issuing the license.
(xii) The statement: “Extra-label use, (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited.”
(xiii) Any other information required by the VFD drug approval regulation.
(5) You must produce the VFD in triplicate.
(6) You must issue a VFD only for the approved conditions and indications for use of the VFD drug.
(b) What must I do with the VFD if I am a veterinarian?
(1) You must give the original VFD to the feed distributor (directly or through the client).
(2) You must keep one copy of the VFD.
(3) You must give the client a copy of the VFD.
(4) You may send a VFD to the client or distributor by facsimile or other electronic means provided you assure that the distributor receives the original signed VFD within 5 working days of receipt of the facsimile or other electronic order.
(5) You may not transmit a VFD by telephone.
(c) What are the VFD recordkeeping requirements?
(1) The VFD feed distributor must keep the VFD original for 2 years from the date of issuance. The veterinarian and the client must keep their copies for the same period of time.
(2) All involved parties must make the VFD available for inspection and copying by FDA.
(3) All involved parties (the VFD feed distributor, the veterinarian, and the client) must keep VFD's transmitted by facsimile or other electronic means for a period of 2 years from date of issuance.
(4) All involved parties must have a copy of the VFD before distribution of a VFD feed to the ultimate user.
(d) What are the notification requirements if I am a distributor of animal feed containing a VFD drug?
(1) You must notify FDA only once, by letter, that you intend to distribute animal feed containing a VFD drug.
(i) The notification letter must include the complete name and address of each business site from which distribution will occur.
(ii) A responsible person from your firm must sign and date the notification letter.
(iii) You must submit the notification letter to the Center for Veterinary Medicine, Division of Animal Feeds (HFV–220), 7500 Standish Pl., Rockville, MD 20855, prior to beginning your first distribution.
(iv) You must notify the Center for Veterinary Medicine at the above address within 30 days of any change in name or business address.
(2) If you are a distributor who ships an animal feed containing a VFD drug to another consignee-distributor in the absence of a valid VFD, you must obtain an “acknowledgment letter,” as defined in §558.3(b)(11), from the consignee-distributor. The letter must include a statement affirming that the consignee-distributor has complied with “distributor notification” requirements of paragraph (d)(1) of this section.
(e) What are the additional recordkeeping requirements if I am a distributor?
(1) You must keep records of receipt and distribution of all medicated animal feed containing a VFD drug.
(2) You must keep these records for 2 years from date of receipt and distribution.
(3) You must make records available for inspection and copying by FDA.
(f) What cautionary statements are required for VFD drugs and animal feeds containing VFD drugs? All labeling and advertising must prominently and conspicuously display the following cautionary statement: “Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice.”
[65 FR 76929, Dec. 8, 2000]
§ 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.
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(a) The Commissioner of Food and Drugs will propose to revoke currently approved subtherapeutic (increased rate of gain, disease prevention. etc.) uses in animal feed of antibiotic and sulfonamide drugs whether granted by approval of new animal drug applications, master files and/or antibiotic or food additive regulations, by no later than April 20, 1975, or the nitrofuran drugs by no later than September 5, 1975, unless data are submitted which resolve conclusively the issues concerning their safety to man and animals and their effectiveness under specific criteria established by the Food and Drug Administration based on the guidelines included in the report of the FDA task force on the use of antibiotics in animal feeds. All persons or firms previously marketing identical, related, or similar products except the nitrofuran drugs not the subject of an approved new animal drug application must submit a new animal drug application by July 19, 1973, or by December 4, 1973, in the case of nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following the effective date of this publication, shall satisfy such criteria prior to approval.
(b) Any person interested in developing data which will support retaining approval for such uses of such antibiotic, nitrofuran, and sulfonamide drugs pursuant to section 512(l) of the Federal Food, Drug, and Cosmetic Act shall submit to the Commissioner the following:
(1) By July 19, 1973, records and reports of completed, ongoing, or planned studies, including protocols, on the tetracyclines, streptomycin, dihydrostreptomycin, penicillin, and the sulfonamides; for all other antibiotics by October 17, 1973; and for the nitrofuran drugs by March 4, 1974. The Food and Drug Administration encourages sponsors to consult with the Center for Veterinary Medicine on protocol design and plans for future studies.
(2) By April 20, 1974, data from completed studies on the tetracyclines, streptomycin, dihydrostreptomycin, the sulfonamides, and penicillin assessing the effect of the subtherapeutic use of the drug in feed on the salmonella reservoir in the target animal as compared to that in nonmedicated controls. Failure to complete the salmonella studies for any of these drugs by that time will be grounds for proceeding to immediately withdraw approval.
(3) By April 20, 1975, data satisfying all other specified criteria for safety and effectiveness, including the effect on the salmonella reservoir for any antibiotic or sulfonamide drugs and by September 5, 1975, for the nitrofuran drugs, approved for subtherapeutic use in animal feeds. Drug efficacy data shall be submitted for any feed-use combination product containing such drug and any feed-use single ingredient antibiotic, nitrofuran, or sulfonamide not reviewed by the National Academy of Sciences—National Research Council, Drug Efficacy Study covering drugs marketed between 1938 and 1962.
(4) Progress reports on studies underway every January 1 and July 1 until completion.
(c) Failure on the part of any sponsor to comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs included in paragraph (b)(1) of this section, or interim results indicating a health hazard, will be considered as grounds for immediately proceeding to withdraw approval of that drug for use in animal feeds under section 512(l) of the act in the case of failure to submit required records and reports and under section 512(e) where new information shows that such drug is not shown to be safe.
(d) Criteria based upon the guidelines laid down by the task force may be obtained from the Food and Drug Administration, Center for Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.
(e) Reports as specified in this section shall be submitted to: Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation (HFV–100), 7500 Standish Pl., Rockville, MD 20855.
(f) Following the completion of the requirements of paragraphs (a) and (b) of this section and the studies provided for therein:
(1) Those antibiotic, nitrofuran, and sulfonamide drugs which fail to meet the prescribed criteria for subtherapeutic uses but which are found to be effective for the therapeutic purposes will be permitted in feed only for high-level, short-term therapeutic use and only by or on the order of a licensed veterinarian.
(2) Animal feeds containing antibacterial drugs permitted to remain in use for subtherapeutic purposes shall be labeled to include a statement of the quantity of such drugs.
(g) The submission of applications and data required by paragraphs (a) and (b) of this section is not required for the continued manufacture of any Type A medicated article which is produced solely from a Type A article that is in compliance with the requirements of this section: Provided, That the Type A medicated article contains no drug ingredient whose use in or on animal feed requires an approved application pursuant to section 512(m) of the act and/or where the Type A article is approved by regulation in this part.
(1) The following antibacterial Type A articles manufactured by the designated sponsors are eligible for interim marketing based on their compliance with the requirements of this section:
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---------------------------------------------------------------------------------------------------------------- Indications for Drug sponsor Type A article Species Use levels use----------------------------------------------------------------------------------------------------------------Fermenta Animal Health Co...... Bacitracin Chicken turkeys, Sec. 558.76....... Sec. 558.76. methylene swine, and cattle. disalicylate.----------------------------------------------------------------------------------------------------------------
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(2) The following is a list of drug combinations permitted when prepared from antibacterial Type A articles listed in paragraph (g)(1) of this section. Drug combinations listed in subpart B of this part name their sponsors and are incorporated herein by reference since they are safe and effective by contemporary standards, or such sponsors have been notified of any additional safety or efficacy data required on an individual basis:
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---------------------------------------------------------------------------------------------------------------- Indications for Drug sponsor Type A article Species Use levels use----------------------------------------------------------------------------------------------------------------PennField Oil Co............... Oxytetracycline and Chickens........... 50 g/ton and 35 to Prevention of neomycin base. 140 g/ton. diseases from oxytetracycline susceptible organisms during periods of stress. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... Chickens (first 2 50 to 100 g/ton Prevention of weeks). and 35 to 140 g/ early chick ton. mortality due to oxytetracycline- susceptible organisms. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... Chickens........... ......do.......... To extend period of high egg production, to improve feed efficiency, to improve egg production and feed efficiency in presence of disease and at time of stress. As an aid in maintaining and improving hatchability where birds are suffering stress from moving, vaccinations, culling, extreme temperature changes, and worming; to improve livability of progeny when losses are due to oxytetracycline- susceptible organisms, to improve egg shell quality, prevention of bluecomb (mud fever or nonspecific enteritis). As an aid in the prevention of bacterial enteritis and in the control of nermycon- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... ......do........... 100 to 200 g/ton Prevention of and 35 to 140 g/ complicated ton. chronic respiratory disease (air-sac infection) and control of complicated chronic respiratory disease by lowering mortality and severity during outbreaks. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... Turkeys............ 50 g/ton and 35 to As an aid in the 140 g/ton. prevention of disease from oxytetracycline susceptible organisms during periods of stress. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... ......do........... 50 to 100 g/ton To extend periord and 35 to 140 g/ of high egg ton. production, to improve egg production, to improve feed efficiency, to improve fertility, to improve egg production and feed efficiency in presence of disease and time of stress; as an aid in maintaining and improving hatchability where birds are suffering from stress, exposure, moving, vaccination, culling, extreme losses due to oxytetracycline- susceptible organisms, and to improve egg shell quality prevention of hexamitiasis. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... Turkeys (first 4 ......do.......... As an aid in the weeks). prevention of early poult mortality due to oxytetracycline- susceptible organisms. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... ......do........... 100 to 150 g/ton As an aid in and 35 to 105 g/ reducing ton. mortality in birds which have suffered an attack of air- sacculitis (it is recommended, wherever possible, to feed from time of attack to marketing). Do............................ ......do........... Turkeys............ ......do.......... As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... ......do........... 100 to 200 g/ton Control of and 35 to 140 g/ bluecomb (mud ton. fever or nonspecific enteritis), infectious sinusitis and hexamitiasis, prevention of infectious synovitis. As an aid in the prevention of bacterial enteritis and in the control of neomycin- sensitive organisms associated with bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... ......do........... 200 g/ton and 70 Control of to 140 g/ton. infectious synovitis. For the treatment of bacterial enteritis and bluecomb (mud fever or nonspecific enteritis). Do............................ ......do........... Swine.............. 50 g/ton and 35 to As an aid in the 140 g/ton. prevention of bacterial enteritis (scours), baby pig diarrhea (in baby pigs only), vibrionic dysentery, bloody dysentery, and salmonellosis (necro or necrotic enteritis). Do............................ ......do........... ......do........... 50 to 150 g/ton As an aid in the and 70 to 140 g/ maintenance of ton. weight gains and feed consumption in the presence of atrophic rhinitis. As an aid in the treatment of bacterial enteritis. Do............................ ......do........... Calves............. 50 g/ton and 35 to As an aid in the 140 g/ton. prevention of bacterial enteritis (scours). Do............................ ......do........... ......do........... 100 g/ton and 70 As an aid in the to 140 g/ton. treatment of bacterial enteritis (scours). Do............................ ......do........... ......do........... 8 to 100 mg/gal As an aid in the and 100 to 200 mg/ prevention of gal reconstituted bacterial milk replacer. diarrhea (scours). Do............................ ......do........... ......do........... 40 to 200 mg/gal As an aid in the and 200 to 400 mg/ treatment of gal reconstituted bacterial milk replacer. diarrhea (scours).----------------------------------------------------------------------------------------------------------------
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[51 FR 8811, Mar. 14, 1986; 51 FR 11014, Apr. 1, 1986, as amended at 51 FR 28547, Aug. 8, 1986; 53 FR 20843, June 7, 1988; 54 FR 37098, Sept. 7, 1989; 54 FR 51386, Dec. 15, 1989; 55 FR 8460, 8462, Mar. 8, 1990; 56 FR 41912, Aug. 23, 1991; 56 FR 64702, Dec. 12, 1991; 57 FR 6476, Feb. 25, 1992; 57 FR 8577, Mar. 11, 1992; 57 FR 14639, Apr. 22, 1992; 58 FR 17515, Apr. 5, 1993; 58 FR 30119, May 26, 1993; 61 FR 51589, Oct. 3, 1996; 64 FR 992, Jan. 7, 1999; 64 FR 37673, July 13, 1999; 71 FR 16221, Mar. 31, 2006]
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
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§ 558.35 Aklomide.
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(a) Approvals. Type A medicated articles: to 053501 in §510.600(c) of this chapter, as follows:
(1) 50 percent aklomide.
(2) 20 percent sulfanitran and 25 percent aklomide.
(3) 25 percent aklomide, 20 percent sulfanitran, and 5 percent roxarsone.
(4) 50 percent aklomide and 10 percent roxarsone.
(b) Related tolerances. See §556.30 of this chapter.
(c) Conditions of use. It is used in feed for chickens as follows:
(1) Amount per ton. Aklomide, 227 grams (0.025 percent).
(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella and E. necatrix.
(ii) Limitations. Not to be fed to birds laying eggs for human consumption.
(2) Amount per ton. Aklomide, 227 grams (0.025 percent) combined with sulfanitran, 181.6 grams (0.02 percent).
(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, and E. acervulina.
(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter.
(3) Amount per ton. Aklomide, 227 grams (0.025 percent) combined with sulfanitran, 181.6 grams (0.02 percent) + roxarsone, 22.7–45.4 grams (0.0025–0.005 percent).
(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, and E. acervulina; growth promition and feed efficiency; improving pigmentation.
(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter; as sole source of organic arsenic; chickens should have access to drinking water at all times.
(4) Amount per ton. Aklomide, 227 grams (0.025 percent) combined with roxarsone, 22.7–45.4 grams (0.0025–0.005 percent).
(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella, and E. necatrix; growth promotion and feed efficiency; improving pigmentation.
(ii) Limitations. Not to be fed to birds laying eggs for human consumption; withdraw 5 days before slaughter; as sole source of organic arsenic; chickens should have access to drinking water at all times.
[40 FR 13959, Mar. 27, 1975, as amended at 41 FR 8312, Feb. 25, 1976; 51 FR 7395, Mar. 3, 1986; 55 FR 8460, Mar. 8, 1990]
§ 558.55 Amprolium.
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(a) Approvals. Type A medicated articles: 25 percent to 050604 in §510.600(c) of this chapter for use as in paragraph (d) of this section.
(b) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(c) Related tolerances. See §556.50 of this chapter.
(d) Conditions of use—(1) Calves. It is top-dressed on or thoroughly mixed in the daily feed ration as follows:
(i) Amount. 227 milligrams per 100 pounds (5 milligrams per kilogram) body weight per day.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii.
(b) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(ii) Amount. 454 milligrams per 100 pounds (10 milligrams per kilogram) body weight per day.
(a) Indications for use. As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii.
(b) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 5 days; for a satisfactory diagnosis, a microscopic examination of the feces should be done by a veterinarian or diagnostic laboratory before treatment; when treating outbreaks, the drug should be administered promptly after diagnosis is determined; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(2) Chickens and turkeys. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams per Amprolium in grams per ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 36.3 to 113.5 (0.004% ........................... Replacement chickens; Feed as follows_ to 0.0125%). development of active immunity to coccidiosis.----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Up to 5 weeks of From 5 to 8 weeks Growing conditions age of age Over 8 weeks of age---------------------------------------------------------------------------------------------------------------- Amprolium Amprolium Amprolium grams per ton grams per ton grams per tonSevere exposure to coccidiosis 113.5 (0.0125%) 72.6-113.5 36.3-113.5 (0.008%-0.0125%) (0.004%-0.0125%)Moderate exposure to coccidiosis 72.6-113.5 54.5-113.5 36.3-113.5 (0.008%-0.0125%) (0.006%-0.0125%) (0.004%-0.0125%)Slight exposure to coccidiosis 36.3-113.5 36.3-113.5 36.3-113.5 (0.004%-0.0125%) (0.004%-0.0125%) (0.004%-0.0125%) ----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams Amprolium in grams per ton per ton Indications for use Limitations Sponsor---------------------------------------------------------------------------------------------------------------- Arsanilate sodium 90 Replacement chickens; Withdraw 5 d before (0.01%). development of active slaughter; as sole immunity to source of organic coccidiosis; growth arsenic; feed promotion and feed according to subtable efficiency; improving in item (i). pigmentation. Arsanilic acid 90 Replacement chickens; Withdraw 5 d before (0.01%). development of active slaughter; as sole immunity to source of organic coccidiosis; growth arsenic; feed promotion and feed according to subtable efficiency; improving in item (i). pigmentation. Arsanilic acid 90 Replacement chickens; Withdraw 5 d before (0.01%) plus development of active slaughter; as sole erythromycin 4.6 to immunity to source of organic 18.5. coccidiosis; growth arsenic. Feed promotion and feed according to subtable efficiency; improving in item (i). pigmentation. Arsanilic acid 90 1. Replacement Feed for 2 d before (0.01%) plus chickens; development stress and 3 to 6 d erythromycin 92.5. of active immunity to after stress; coccidiosis; growth withdraw 5 d before promotion and feed slaughter; as sole efficiency; improving source of organic pigmentation; as an arsenic. Feed aid in the prevention according to subtable of chronic in item (i). respiratory disease during periods of stress. 2. Replacement Feed for 7 to 14 d; chickens; development withdraw 5 d before of active immunity to slaughter; as sole coccidiosis; growth source of organic promotion and feed arsenic. Feed efficiency; improving according to subtable pigmentation; as an in item (i). aid in the prevention of infectious coryza.(i) 36.3 to 113.5 (0.004% to Arsanilic acid 90 Replacement chickens; Feed for 5 to 8 d; do ......... 0.0125%). (0.01%) plus development of active not use in birds erythromycin 185. immunity to producing eggs for coccidiosis; growth food purposes; promotion and feed withdraw 5 d before efficiency; improving slaughter; as sole pigmentation; as an source of organic aid in the prevention arsenic. Feed and reduction of according to subtable lesions and in in item (i). lowering severity of chronic respiratory disease. Bacitracin 100 to 200.. Replacement chickens; As bacitracin ......... development of active methylene immunity to disalicylate or coccidiosis; bacitracin zinc. Feed treatment of chronic according to subtable respiratory disease in item (i). (air-sac infection) and blue comb (nonspecific infectious enteritis). Bacitracin methylene Replacement chickens; Feed according to 046573 disalicylate 4 to 50. development of active subtable in item (i); immunity to bacitracin methylene coccidiosis, disalicylate as increased rate of provided by 046573 in weight gain, and § 510.600(c) of improved feed this chapter.. efficiency.. Bacitracin methylene Replacement chickens; Feed according to 046573 disalicylate 50 plus development of active subtable in entry roxarsone 22.7 to 45.4. immunity to (i); bacitracin coccidiosis; as an methylene aid in the control of disalicylate and necrotic enteritis roxarsone as provided caused or complicated by 046573 in § by Clostridium spp. 510.600(c) of this or other organisms chapter.. susceptible to bacitracin; increased rate of weight gain, improved feed efficiency, and improved pigmentation.. Chlortetracycline 100 Chickens; development Do not feed to ......... to 200. of active immunity to chickens producing coccidiosis; control eggs for human of infectious consumption. Feed for synovitis caused by 7 to 14 d. Mycoplasma synoviae susceptible to chlortetracycline. Chlortetracycline 200 Chickens; development Do not feed to ......... to 400. of active immunity to chickens producing coccidiosis; control eggs for human of chronic consumption. Feed for respiratory disease 7 to 14 d. (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. Erythromycin 4.6 to Replacement chickens; As erythromycin ......... 18.5. development of active thiocyanate. Feed immunity to according to subtable coccidiosis; growth in item (i). promotion and feed efficiency. Erythromycin 92.5...... 1. Replacement Feed for 7 to 14 d; ......... chickens; development withdraw 24 h before of active immunity to slaughter. Feed coccidiosis; as an according to subtable aid in the prevention in item (i). of infectious coryza. 2. Replacement Feed for 2 d before ......... chickens; development stress and 3 to 6 d of active immunity to after stress; coccidiosis; as an withdraw 24 h before aid in the prevention slaughter. Feed of chronic according to subtable respiratory disease in item (i). during periods of stress. Erythromycin 185....... Replacement chickens; Feed for 5 to 8 d; do ......... development of active not use in birds immunity to producing eggs for coccidiosis; as an food purposes; aid in the prevention withdraw 48 h before and reduction of slaughter. Feed lesions and in according to subtable lowering severity of in item (i). chronic respiratory disease. Hygromycin B 8 to 12... Replacement chickens; Feed according to ......... development of active subtable in item (i). immunity to coccidiosis; control of infestation of large round worms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Penicillin 2.4 to 50... Replacement chickens; As procaine ......... development of active penicillin. Feed immunity to according to subtable coccidiosis; growth in item (i). promotion and feed efficiency. Roxarsone 22.7 to 45.4 Replacement chickens; Withdraw 5 d before ......... (0.0025% to 0.005%). development of active slaughter; as sole immunity to source of organic coccidiosis; growth arsenic. Feed promotion, and feed according to subtable efficiency; improving in item (i). pigmentation.(ii) 72.6 to 113.5 (0.008% ....................... Broiler chickens; Feed according to ......... to 0.0125%). prevention of subtable in item (i). coccidiosis caused by Eimeria tenella only. Arsanilate sodium 90 Broiler chickens; Withdraw 5 d before (0.01%). prevention of slaughter; as sole coccidiosis caused by source of organic E. tenella only; arsenic. growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 ......do.............. ......do.............. (0.01%). Bacitracin 100 to 200.. Broiler chickens; As bacitracin prevention of methylene coccidiosis caused by disalicylate, or zinc E. tenella only; bacitracin. treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis). Chlortetracycline 100 Chickens; prevention Do not feed to to 200. of coccidiosis caused chickens producing by E. tenella only; eggs for human control of infectious consumption. Feed for synovitis caused by 7 to 14 d. M. synoviae susceptible to chlortetracycline. Chlortetracycline 200 Chickens; prevention Do not feed to to 400. of coccidiosis caused chickens producing by E. tenella only; eggs for human control of chronic consumption. Feed for respiratory disease 7 to 14 d. (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. Hygromycin B 8 to 12... Broiler chickens; Feed according to prevention of subtable in item (i). coccidiosis caused by Eimeria tenella only; control of infestation of large round worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Penicillin 2.4 to 50... Broiler chickens; As procaine penicillin prevention of coccidiosis caused by E. tenella only; growth promotion and feed efficiency. Roxarsone 22.7 to 45.4 Broiler chickens; Withdraw 5 d before (0.0025% to 0.005%). prevention of slaughter; as sole coccidiosis caused by source of organic E. tenella only; arsenic. growth promotion and feed efficiency; improving pigmentation.(iii) 113.5 (0.0125%)....... ....................... 1. Laying chickens; ...................... prevention of coccidiosis. 2. Laying chickens; For moderate outbreaks treatment of of coccidiosis; coccidiosis. administer for 2 weeks. Bambermycins 1 to 3 Broiler chickens; as Feed continuously as 016592 plus roxarsone 22.8 to an aid in the the sole ration; as 34.1 (0.0025% to prevention of sole source of 0.00375%). coccidiosis; for amprolium and organic increased rate of arsenic; roxarsone as weight gain, improved provided by No. feed efficiency, and 053501 in § improved pigmentation. 510.600(c) of this chapter, bambermycins by No. 016592; withdraw 5 d before slaughter. Bambermycins 1 to 4.... Growing turkeys; Feed continuously as 016592 prevention of the sole source of coccidiosis; amprolium; increased rate of bambermycins as weight gain and provided by No. improved feed 016592 in § efficiency. 510.600(c) of this chapter.(iv) 113.5 to 227 (0.0125% ....................... 1. Broiler chickens to 0.025%). and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis. 2. Turkeys; prevention of coccidiosis. Arsanilate sodium 90 1. Broiler chickens Withdraw 5 d before (0.01%). and replacement slaughter; as sole chickens where source of organic immunity to arsenic. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 1. Broiler chickens ......do.............. (0.01%). and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 1. Broiler chickens Feed for 2 d before (0.01%) plus and replacement stress and 3 to 6 d erythromycin 92.5. chickens where after stress; immunity to withdraw 5 d before coccidiosis is not slaughter; as sole desired; prevention source of organic of coccidiosis; arsenic. growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of chronic respiratory disease during periods of stress. 2. Broiler chickens Feed for 7 to 14 d; and replacement withdraw 5 d before chickens where slaughter; as sole immunity to source of organic coccidiosis is not arsenic. desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of infectious coryza. Arsanilic acid 90 Broiler chickens and Feed for 5 to 8 d; do (0.01%) plus replacement chickens not use in birds erythromycin 185. where immunity to producing eggs for coccidiosis is not food purposes; desired; prevention withdraw 5 d before of coccidiosis; slaughter; as sole growth promotion and source of organic feed efficiency; arsenic. improving pigmentation; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease. Arsanilic acid 90 Broiler chickens and Withdraw 5 d before (0.01%) plus replacement chickens slaughter; as sole erythromycin 4.6 to where immunity to source of organic 18.5. coccidiosis is not arsenic. desired; prevention of coccidiosis; growth promotion and feed efficiency; improved pigmentation. Bacitracin 4 to 50..... 1. Broiler chickens As bacitracin \1\ and replacement methylene 012769 chickens where disalicylate or immunity to bacitracin zinc. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency. Bacitracin 100 to 200.. 1. Broiler chickens ......do.............. and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection), blue comb (nonspecific infectious enteritis). 2. Broiler chickens As bacitracin zinc.... and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic ry disease (air-sac infection), blue comb (nonspecific infectious enteritis). Bacitracin 100 to 500.. Turkeys; prevention of As bacitracin zinc.... coccidiosis; treatment of infectious sinusitis, blue comb (mud fever). Bacitracin plus ......do.............. Feed contains 50% to penicillin 100 to 500 75% of bacitracin but (of combination). not more than 125 g penicillin; as procaine penicillin; as bacitracin zinc. Carbarsone 227 to 340.5 Turkeys; aid in Feed continuously 2 000006 prevention of weeks before coccidiosis (Eimeria coccidiosis and adenoeides, E. blackhead are meleagrimitis, and E. expected and continue gallopavonis) and as long as prevention blackhead. is needed; withdraw 5 days before slaughter; use as sole source of amprolium and organic arsenic; do not use as a treatment for outbreaks of coccidiosis; carbarsone by 046573 in § 510.600(c) of this chapter. Chlortetracycline 100 Chickens where Do not feed to to 200. immunity to chickens producing coccidiosis is not eggs for human desired; prevention consumption. Feed for of coccidiosis; 7 to 14 d. control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. Chlortetracycline 200 Chickens where Do not feed to to 400. immunity to chickens producing coccidiosis is not eggs for human desired; control of consumption. Feed for chronic respiratory 7 to 14 d. disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. Erythromycin 4.6 to Broiler chickens and As erythromycin 18.5. replacement chickens thiocyanate. where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. Erythromycin 92.5...... 1. Broiler chickens Feed for 2 d before and replacement stress and 3 to 6 d chickens where after stress; immunity to withdraw 24 h before coccidiosis is not slaughter. desired; prevention of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress. 2. Broiler chickens Feed for 7 to 14 d; and replacement withdraw 24 h before chickens where slaughter. immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza. Erythromycin 185....... Broiler chickens and Feed for 5 to 8 d, do replacement chickens not use in birds where immunity to producing eggs for coccidiosis is not food purposes; desired; prevention withdraw 48 h before of coccidiosis; as an slaughter. aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease. Hygromycin B 8 to 12... Broiler chickens and Feed according to replacement chickens subtable in item (i). where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infestation of large round worms (Heterakis gallinae) and capillary worms (Capillaria obsignata). Penicillin 2.4 to 50... 1. Broiler chickens As procaine penicillin and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency. Roxarsone 22.7 to 45.4 1. Broiler chickens Withdraw 5 d before (0.0025% to 0.005%). and replacement slaughter; as sole chickens where source of organic immunity to arsenic. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency; improving pigmentation.(v) 227 (0.025%)............ ....................... Laying chickens; For severe outbreaks ......... treatment of of coccidiosis; coccidiosis. administer for 2 weeks.----------------------------------------------------------------------------------------------------------------
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(3) Pheasants. It is used as follows:
(i) Amount. 0.0175 percent (159 grams per ton).
(ii) Indications for use. For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duodenalis, and E. phasiani.
(iii) Limitations. Feed continuously as sole ration. Use as sole source of amprolium. Fertility, hatchability, and other reproductive data are not available on amprolium in breeding pheasants. Do not use in feeds containing bentonite.
[41 FR 10985, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.55, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.58 Amprolium and ethopabate.
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(a) Specifications. Type A medicated articles containing:
(1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate;
(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate.
(b) Approvals. See No. 050604 in §510.600(c) of this chapter.
(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(d) Related tolerances. See §§556.50 and 556.260 of this chapter.
(e) Conditions of use. (1) It is used for chickens as follows:
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---------------------------------------------------------------------------------------------------------------- Amprolium and ethopabate in Combination in grams grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) Amprolium 113.5 (0.0125 ....................... Broiler chickens as an Not for laying hens; pct) and ethopabate 3.6 aid in the prevention as sole source of (0.0004 pct). of coccidiosis. amprolium. Bambermycins, 1 to 3; Broiler chickens: As Feed continuously as 016592 plus roxarsone, 22.8 an aid in the the sole ration; as to 34.1. prevention of sole source of coccidiosis; and for amprolium and organic increased rate of arsenic; withdraw 5 d weight gain, improved before slaughter; feed efficiency, and roxarsone provided by improved No. 046573, pigmentation.. bambermycins by No. 016592 in § 510.600(c) of this chapter..(ii) Amprolium 113.5 Bambermycins 2 to 3 Broiler chickens; as Feed continuously as 016592 (0.0125%) and ethopabate plus roxarsone 22.8 to an aid in the the sole ration; as 3.6 (0.0004%). 34.1 (0.0025% to prevention of sole source of 0.00375%). coccidiosis; for amprolium and organic increased rate of arsenic; amprolium weight gain, improved and ethopabate as feed efficiency, and provided by No. pigmentation. 050604 in § 510.600(c) of this chapter, roxarsone by No. 046573, bambermycins by No. 016592; withdraw 5 d before slaughter. Lincomycin 2 to 4...... Broiler chickens; for Not for laying increase in rate of chickens; as weight gain; improved lincomycin feed efficiency; as hydrochloride an aid in the monohydrate; as sole prevention of source of amprolium. coccidiosis. Lincomycin 2 to 4 plus Broiler chickens; for Not for laying roxarsone 45.4 increase in rate of chickens; as (0.005%). weight gain; improved lincomycin feed efficiency and hydrochloride pigmentation; as an monohydrate; withdraw aid in the prevention 5 d before slaughter; of coccidiosis. as sole source of amprolium and organic arsenic. Roxarsone 45.4 (0.005 Broiler chickens; to Do not feed to laying pct). aid in prevention of chickens; withdraw 5 coccidiosis where d before slaughter; severe exposure to as sole source of coccidiosis from amprolium; do not use Eimeria acervulina, as a treatment for E. maxima, and E. outbreaks of brunetti is likely to coccidiosis; feed as occur; for increased sole ration from time rate of weight gain chickens are placed in broiler chickens on litter until the raised in floor pens. past the time when coccidiosis is ordinarily a hazard; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combinations as provided by No. 050604.(iii) Amprolium 113.5 ....................... Broiler chickens and Not for chickens over (0.0125%) and ethopabate replacement chickens 16 weeks of age. 36.3 (0.004%). where immunity to coccidiosis is not desired; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. Arsanilic acid 90 (0.01 Broiler chickens and Not for laying hens; 061133 pct) plus erythromycin replacement chickens withdraw 5 d before 4.6 to 18.5. where immunity to slaughter; as sole coccidiosis is not source of organic desired; prevention arsenic; as of coccidiosis; erythromycin growth promotion and thiocyanate. feed efficiency; improve pigmentation. Bacitracin 4 to 50..... 1. Broiler chickens Not for chickens over and replacement 16 weeks of age; do chickens where not feed to laying immunity to chickens; as sole coccidiosis is not source of amprolium; desired; to aid in not for use as a prevention of treatment for coccidiosis where outbreaks of severe exposure to coccidiosis; as coccidiosis from bacitracin methylene Eimeria acervulina, disalicylate as E. maxima, and E. provided by No. brunetti is likely to 046573 or bacitracin occur; for increased zinc as provided by rate of weight gain No. 046573 in § in broiler chickens 510.600(c) of this raised in floor pens. chapter; feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard; combination as provided by No. 050604 in § 510.600(c) of this chapter. ....................... 2. Broiler chickens; Not for chickens over 046573 as an aid in 16 weeks of age; do prevention of not feed to laying coccidiosis where chickens; as sole severe exposure to source of amprolium; coccidiosis from not for use as a Eimeria acervulina, treatment for E. maxima, and E. coccidiosis; brunetti is likely to bacitracin zinc as occur; improved feed provided by No. efficiency. 046573 in § 510.600(c) of this chapter; feed as the sole ration from the time chickens are placed on litter until market weight; combination as provided by No. 046573.. Bacitracin 5 to 35 plus Broiler chickens; for Do not feed to laying roxarsone 34 increased rate of chickens; withdraw 5 (0.00375%). weight gain and as an d before slaughter; aid in the prevention as sole source of of coccidiosis where amprolium and organic severe exposure to arsenic; do not use coccidiosis from as a treatment for Eimeria acervulina, outbreaks of E. maxima, and E. coccidiosis; feed as brunetti is likely to the sole ration from occur in broiler time chickens are chickens raised in placed on litter floor pens. until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 050604 in § 510.600(c) of this chapter; bacitracin methylene disalicylate as provided by No. 046573 or bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combination as provided by No. 050604 in § 510.600(c) of this chapter. Bacitracin 20 to 35 Broiler chickens; for Do not feed to laying plus roxarsone 34 increased rate of chickens; withdraw 5 (0.00375%). weight gain, improved d before slaughter; feed efficiency, and as sole source of as an aid in the amprolium and organic prevention of arsenic; do not use coccidiosis where as a treatment for severe exposure to outbreaks of coccidiosis from coccidiosis; feed as Eimeria acervulina, the sole ration from E. maxima, and E. time chickens are brunetti is likely to placed on litter occur in broiler until past the time chickens raised in when coccidiosis is floor pens. ordinarily a hazard; amprolium and ethopabate as provided by No. 050604 in § 510.600(c) of this chapter; bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combination as provided by No. 050604 in § 510.600(c) of this chapter. Bacitracin 10 to 50 Broiler chickens; as Do not feed to laying 046573 plus roxarsone 15.4 to an aid in prevention chickens; withdraw 5 45.4 (0.0017% to of coccidiosis where d before slaughter; 0.005%). severe exposure to as sole source of coccidiosis from amprolium and organic Eimeria acervulina, arsenic; do not use E. maxima, and E. as a treatment for brunetti is likely to outbreaks of occur; improved feed coccidiosis; feed as efficiency. the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 050604 in § 510.600(c) of this chapter; bacitracin zinc as provided by No. 046573 roxarsone as provided by No. 046573 combination as provided by No. 046573. Bacitracin 10 plus Broiler chickens; as ......do.............. 063238 roxarsone 30 to 45.4 an aid in prevention (0.0033% to 0.005%). of coccidiosis where severe exposure to coccidiosis from E. acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency and improved pigmentation. Bambermycins 1 to 3.... Broiler chickens; as Feed continuously as an aid in the the sole ration; as prevention of sole source of coccidiosis where amprolium; amprolium, severe exposure to ethopabate as coccidiosis from provided by No. Eimeria acervulina, 050604 in § E. maxima, and E. 510.600(c) of this brunetti is likely to chapter, bambermycins occur; for increased as provided by No. rate of weight gain, 057926 in § and improved feed 510.600(c) of this efficiency. chapter. Bambermycins 1 to 3 Broiler chickens; as Feed continuously as 016592 plus roxarsone 22.8 to an aid in the the sole ration; as 34.1 (0.0025% to prevention of sole source of 0.00375%). coccidiosis where amprolium and organic severe exposure to arsenic; amprolium coccidiosis from and ethopabate as Eimeria acervulina, provided by No. E. maxima, and E. 050604 in § brunetti is likely to 510.600(c) of this occur; for increased chapter, roxarsone by rate of weight gain; No. 046573 improved feed bambermycins by No. efficiency, and 016592. Withdraw 5 improved pigmentation. days before slaughter. Erythromycin 4.6 to Broiler chickens and Not for laying hens; 18.5. replacement chickens withdraw 24 hours where immunity to before slaughter; coccidiosis is not erythromycin desired; prevention thiocyanate. of coccidiosis; growth promotion and feed efficiency. Virginiamycin, 15...... Broiler chickens, as Feed continuously as 000069 an aid in the sole ration, do not prevention of feed to laying hens, coccidiosis where not for chickens over severe exposure to 16 weeks of age, as Eimeria acervulina, sole source of E. brunetti, and E. amprolium, amprolium maxima is likely to and ethopabate as occur, for increased provided by 050604 in rate of weight gain § 510.600(c), and improved feed virginiamycin as efficiency. provided by 066104. Virginiamycin, 5 to 15. Broiler chickens, as ......do.............. an aid in the prevention of coccidiosis where severe exposure to Eimeria acervulina, E. brunetti, and E. maxima is likely to occur, for increased rate of weight gain.(iv) Amprolium 113.5 to 227 ....................... For broiler chickens Not for laying hens... (0.0125% to 0.025%) and and replacement ethopabate 3.6 (0.0004%). chickens where immunity to coccidiosis is not desired; prevention of coccidiosis. Arsanilic acid 90 Broiler chickens and As sole source of (0.01%). replacement chickens organic arsenic; where immunity to withdraw 5 d before coccidiosis is not slaughter; not for desired; prevention laying hens. of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 1. For broiler Feed for 2 d before (0.01%) plus chickens and stress and 3 to 6 d erythromycin 92.5. replacement chickens after stress; where immunity to withdraw 5 d before coccidiosis is not slaughter; as sole desired; prevention source of organic of coccidiosis; as an arsenic; not for aid in the prevention laying hens. of chronic respiratory disease during periods of stress; growth promotion and feed efficiency; improving pigmentation. 2. For broiler Feed for 7 to 14 d; chickens and withdraw 5 d before replacement chickens slaughter; as sole where immunity to source of organic coccidiosis is not arsenic; not for desired; prevention laying hens. of coccidiosis; as an aid in the prevention of infectious coryza; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 For broiler chickens Feed for 5 to 8 d; do (0.01%) plus and replacement not use in birds erythromycin 185. chickens where producing eggs for immunity to food purposes; coccidiosis is not withdraw 5 d before desired; prevention slaughter; as sole of coccidiosis; as an source of organic aid in the prevention arsenic. and reduction of lesions and in lowering severity of chronic respiratory disease; growth promotion and feed efficiency; improving pigmentation. Bacitracin 4 to 50..... For broiler chickens As bacitracin and replacement methylene chickens where disalicylate; not for immunity to laying hens. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. Bacitracin 100 to 200.. 1. Broiler chickens ......do.............. and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis). 2. For broiler As zinc bacitracin, chickens and not for laying hens. replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection), blue comb (nonspecific infectious enteritis). Bacitracin 4 to 50 plus Broiler chickens and As bacitracin roxarsone 22.7 to 45.4 replacement chickens methylene (0.0025% to 0.005%). where immunity to disalicylate; not for coccidiosis is not laying hens; as sole desired; prevention source of organic of coccidiosis; arsenic; withdraw 5 d growth promotion and before slaughter. feed efficiency; improving pigmentation. Chlortetracycline 100 For chickens where Do not feed to to 200. immunity to chickens producing coccidiosis is not eggs for human desired; prevention consumption. Feed for of coccidiosis; 7 to 14 d. control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Chlortetracycline 200 For chickens where In low calcium feed to 400. immunity to containing 0.8% coccidiosis is not dietary calcium and desired; prevention 1.5% sodium sulfate; of coccidiosis; feed continuously as control of chronic sole ration for 7 to respiratory disease 14 d; do not feed to (CRD) and air sac chickens producing infection caused by eggs for human M. gallisepticum and consumption. E. coli susceptible to chlortetracycline. Erythromycin 92.5...... 1. For broiler Feed for 2 d before chickens and for stress and 3 to 6 d replacement chickens after stress; where immunity to withdraw 24 h before coccidiosis is not slaughter; not for desired; prevention laying hens. of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress. 2. For broiler Feed for 7 to 14 d; chickens and withdraw 24 h before replacement chickens slaughter; not for where immunity to laying hens. coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza. Erythromycin 185....... For broiler chickens Feed for 5 to 8 d; do and replacement not use in birds chickens where producing eggs for immunity to food purposes; coccidiosis is not withdraw 48 h before desired; prevention slaughter. of coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease. Penicillin 2.4 to 50... For broiler chickens Not for laying hens; and replacement as procaine chickens where penicillin. immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Roxarsone 22.7 to 45.4 Broiler chickens and As sole source of ......... (0.0025% to 0.005%). replacement chickens organic arsenic; where immunity to withdraw 5 d before coccidiosis is not slaughter; not for desired; prevention laying hens. of coccidiosis; growth promotion and feed efficiency; improving pigmentation.----------------------------------------------------------------------------------------------------------------
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(2) [Reserved]
[41 FR 10990, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.58, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.59 Apramycin.
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(a) Approvals. Type A articles to sponsors identified in §510.600(c) of this chapter as follows:
(1) 000986 for 75 grams apramycin (as apramycin sulfate) per pound for use as in paragraph (d)(1) of this section.
(2) [Reserved]
(b) [Reserved]
(c) Related tolerances. See §556.52 of this chapter.
(d) Conditions of use—(1) Swine—(i) Amount. 150 grams per ton.
(ii) Indications for use. For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli.
(iii) Limitations. Use for 14 days. Withdraw 28 days before slaughter.
(2) [Reserved]
[51 FR 9190, Mar. 18, 1986]
§ 558.60 Arsanilate sodium.
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(a) Appprovals. Type A medicated articles: 20, 50, or 100 percent to 015565 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.60 of this chapter.
(c) Conditions of use. (1) It is used for chickens and turkeys as follows:
(i) Grams per ton. 90 (0.01 percent).
(ii) Indications for use. For growth promotion and feed efficiency; improving pigmentation.
(iii) Limitations. Withdraw 5 days before slaughter; as sole source of organic arsenic.
(2) Arsanilate sodium may be used in accordance with the provisions of this section in the combinations provided as follows:
(i) Amprolium in accordance with §558.55.
(ii) Zoalene in accordance with §558.680.
[41 FR 10992, Mar. 15, 1976, as amended at 51 FR 7395, Mar. 3, 1986; 51 FR 33897, Sept. 24, 1986]
§ 558.62 Arsanilic acid.
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(a) Approvals. Type A medicated articles to sponsors in §510.600(c) of this chapter as follows:
(1) To 015565: 20, 50, and 100 percent for use as in the table in paragraph (c)(1), entry (ii), item 1; entry (ii), item 2; entry (iv); entry (vi); and entry (vii) of this section.
(2) To 015565: 20 percent for use as in paragraph (c)(1), entry (i); entry (ii), item 3 of this section.
(3) To 061133: 90 grams per pound arsanilic acid and 4.6 grams per pound erythromycin equivalents as erythromycin thiocyanate for use as in paragraph (c)(1), entry (iii); 90 grams per pound arsanilic acid and 9.25 grams per pound erythromycin equivalents as erythromycin thiocyanate for use as in paragraph (c)(1), entry (v).
(b) Related tolerances. See §556.60 of this chapter.
(c) Conditions of use. (1) It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Arsanilic acid in grams per Combination in grams ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 45 to 90................ ....................... 1. Growing chickens: Withdraw 5 days before 015565 For growth promotion slaughter; as sole and feed efficiency; source of organic improving arsenic. pigmentation. ....................... 2. Growing turkeys: .......do............. 015565 For growth promotion and feed efficiency; improving pigmentation. ....................... 3. Growing swine: For .......do............. 015565 increased rate of weight gain and improved feed efficiency.(ii) 90..................... ....................... Swine: As an aid in .......do............. 015565 control of swine dysentery (hemorrhagic enteritis, bloody dysentery).(iii)....................... Erythromycin 4.6....... Chickens; growth As erythromycin 012487 promotion and feed thiocyanate; withdraw efficiency; improving 5 days before pigmentation.. slaughter; as sole source of organic arsenic..(iv)........................ Erythromycin 4.6 to Chickens; growth As erythromycin 15565 18.5. promotion and feed thiocyanate; withdraw efficiency; improving 5 days before pigmentation. slaughter; as sole source of organic arsenic.(v)......................... Erythromycin 9.25...... Chickens; growth As erythromycin 012487 promotion and feed thiocyanate; withdraw efficiency; improving 5 days before pigmentation.. slaughter; as sole source of organic arsenic..(vi)........................ Erythromycin 92.5...... 1. Chickens; as an aid As erythromycin 015565 in the prevention of thiocyanate; feed for chronic respiratory 2 days before stress disease during and 3 to 6 days after periods of stress; stress; withdraw 5 growth promotion and days before feed efficiency; slaughter; as sole improving source of organic pigmentation. arsenic. 2. Chickens; as an aid As erythromycin 015565 in the prevention of thiocyanate; feed for infectious coryza; 7 to 14 days; growth promotion and withdraw 5 days feed efficiency; before slaughter; as improving sole source of pigmentation. organic arsenic.(vii)....................... Erythromycin 185....... Chickens; as an aid in As erythromycin 15565 the prevention and thiocyanate; feed for reduction of lesions 5 to 8 days; do not and in lowering use in birds severity of chronic producing eggs for respiratory disease; food purposes; growth promotion and withdraw 5 days feed efficiency; before slaughter; as improving sole source of pigmentation. organic arsenic.----------------------------------------------------------------------------------------------------------------
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(2) Arsanilic acid may be used in accordance with the provisions of this section in the combinations provided as follows:
(i) Amprolium in accordance with §558.55.
(ii) Amprolium and ethopabate in accordance with §558.58.
(iii) Bacitracin zinc in accordance with §558.78.
(iv) Bacitracin and zoalene in accordance with §558.680.
(v) Zoalene in accordance with §558.680.
[41 FR 10992, Mar. 15, 1976, as amended at 42 FR 18617, Apr. 8, 1977; 51 FR 7395, Mar. 3, 1986; 51 FR 33897, Sept. 24, 1986; 54 FR 18281, Apr. 28, 1989; 56 FR 19268, Apr. 26, 1991; 60 FR 39847, Aug. 4, 1995; 66 FR 14074, Mar. 9, 2001; 66 FR 57873, Nov. 19, 2001]
§ 558.76 Bacitracin methylene disalicylate.
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(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound to 046573 in §510.600(c) of this chapter.
(b) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard.
(c) Related tolerances. See §556.70 of this chapter.
(d) Conditions of use. (1) It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Bacitracin methylene disalicylate in grams per Combination in grams Indications for use Limitations Sponsor ton per ton----------------------------------------------------------------------------------------------------------------(i) 4 to 50................. ....................... Chickens, turkeys, and ...................... 046573 pheasants; increased rate of weight gain and improved feed efficiency \1\.(ii) 5 to 20................ ....................... Quail not over 5 weeks ...................... 046573 of age; increased rate of weight gain and improved feed efficiency \1\.(iii) 10 to 25.............. ....................... Chickens; for For first 7 months of 046573 increased egg production. production and improved feed efficiency for egg production.(iv) 10 to 30............... ....................... Swine: for increased For growing and 046573 rate of weight gain finishing swine. and improved feed efficiency. Chlortetracycline Swine; for increased Feed for not more than 046573 approximately 400, rate of weight gain 14 days; bacitracin 048164 varying with body and improved feed methylene weight and food efficiency; for disalicylate provided consumption to provide treatment of by No. 046573; 10 milligrams per bacterial enteritis chlortetracycline pound of body weight caused by Escherichia provided by Nos. per day. coli and Salmonella 046573 and 048164 in choleraesuis and § 510.600(c) of bacterial pneumonia this chapter. caused by Pasteurella multocida susceptible to chlortetracycline. Swine; for control of Feed for not more than 046573 porcine proliferative 14 days; enteropathies chlortetracycline and (ileitis) caused by BMD as provided by Lawsonia 046573 in § intracellularis 510.600(c) of this susceptible to chapter. chlortetracycline.(v) [Reserved](vi) 50..................... ....................... Broiler chickens; as ...................... 046573 an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; Feed continuously as 046573 as an aid in the sole ration. prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.(vii)-(viii) [Reserved](ix) 100 to 200............. ....................... Broiler chickens; as ...................... 046573 an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; Feed continuously as 046573 as an aid in the sole ration. Start at control of necrotic first clinical signs enteritis caused or of disease, vary complicated by dosage based on Clostridium spp. or severity of other organisms infection, administer susceptible to continuously for 5 to bacitracin. 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t).(x) 200..................... ....................... Turkeys; as an aid in ...................... 046573 the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate. Quail; for the From Type A medicated 046573 prevention of articles containing ulcerative enteritis 25, 40, or 50 grams in growing quail due of bacitracin to Clostridium methylene colinum susceptible disalicylate. Feed to bacitracin continuously as the methylene sole ration. disalicylate.(xi) 250.................... ....................... 1. Growing/Finishing As the sole ration. 046573 Swine: For control of Not for use in swine swine dysentery weighing more than associated with 250 pounds. Diagnosis Treponema should be confirmed hyodysenteriae on by a veterinarian premises with a when results are not history of swine satisfactory. dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition. 2. Pregnant sows: For As the sole ration. ......... control of Feed to sows from 14 clostridial enteritis days before through caused by C. 21 days after perfringens in farrowing on premises suckling piglets. with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory.----------------------------------------------------------------------------------------------------------------\1\ These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
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(2) It is used as bacitracin methylene disalicylate in feed for animals as follows:
(i) Amount. 70 milligrams per head per day.
(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.
(b) Limitations. Administer continuously throughout the feeding period.
(ii) Amount. 250 milligrams per head per day.
(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.
(b) Limitations. Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period.
(3) Bacitracin methylene disalicylate may also be used with:
(i) Amprolium as in §558.55.
(ii) Amprolium and ethopabate as in §558.58.
(iii) Carbarsone (not USP) as in §558.120.
(iv) Decoquinate alone and with roxarsone as in §558.195.
(v) Diclazuril alone and with roxarsone as in §558.198.
(vi) Fenbendazole as in §558.258.
(vii) Halofuginone hydrobromide alone and with roxarsone as in §558.265.
(viii) Hygromycin B as in §588.274.
(ix) Ivermectin as in §558.300.
(x) Lasalocid sodium alone and with roxarsone as in §558.311.
(xi) Monensin alone and with roxarsone as in §588.355.
(xii) Narasin alone and with roxarsone as in §558.363.
(xiii) Nicarbazin alone or with narasin or roxarsone or with narasin and roxarsone as in §558.366.
(xiv) Nitarsone as in §558.369.
(xv) Robenidine alone and with roxarsone as in §558.515.
(xvi) Salinomycin alone and with roxarsone as in §558.550.
(xvii) Semduramicin alone and with roxarsone as in §558.555.
(xviii) Zoalene alone and with arsanilic acid or roxarsone as in §558.680.
[41 FR 10993, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.76, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.78 Bacitracin zinc.
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(a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 5, 10, 25, 40, or 50 grams per pound bacitracin.
(b) Approvals. See sponsors in §510.600(c) of this chapter for uses as follows:
(1) No. 046573: 10, 25, 40, and 50 grams per pound for uses as in paragraph (d) of this section.
(2) No. 048164: 5 and 50 grams per pound for use as in as in paragraph (d)(1)(i) of this section.
(c) Related tolerances. See §556.70 of this chapter.
(d) Conditions of use. (1) It is used as follows:
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----------------------------------------------------------------------------------------------------------------Bacitracin zinc in grams per Combinations in grams ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 4 to 50................. ....................... Chickens: for Growing chickens...... 046573 increased rate of 048164 weight gain and improved feed efficiency.(ii) 4 to 50................ ....................... Turkeys and pheasants: Growing turkeys and 046573 for increased rate of pheasants. weight gain and improved feed efficiency.(iii) 5 to 20............... ....................... Quail; for increased Growing quail; feed as 046573 rate of weight gain the Type C feed to and improved feed starting quail efficiency. through 5 weeks of age.(iv) 10 to 25............... ....................... Laying chickens; ...................... 046573 improved feed efficiency and increased egg production.(v) 10 to 50................ ....................... Swine; increased rate Growing and finishing 046573 of weight gain and swine. improved feed efficiency.(vi) 20..................... ....................... Growing-finishing In Type C feed........ 046573 swine; increased rate of weight gain.(vii) 20 to 40.............. ....................... Growing-finishing ......do.............. 046573 swine; improved feed efficiency.----------------------------------------------------------------------------------------------------------------
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(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows:
(i) To aid in stimulating growth and improving feed efficiency.
(ii) For increased rate of weight gain and improved feed efficiency; see sponsor 046573.
(3) It may be used as approved in combination with:
(i) Amprolium alone and with roxarsone as in §558.55.
(ii) Amprolium and ethopabate alone and with roxarsone as in §558.58.
(iii) Carbarsone as in §558.120.
(iv) Clopidol alone and with roxarsone as in §558.175.
(v) Decoquinate alone and with roxarsone as in §558.195.
(vi) Hygromycin B alone and with penicillin as in §558.274.
(vii) Lasalocid sodium alone or with roxarsone as in §558.311.
(viii) Monensin alone and with roxarsone as in §558.355.
(ix) Naracin as in §558.363.
(x) Nitarsone as in §558.369.
(xi) Robenidine as in §558.515.
(xii) Salinomycin alone and with roxarsone as in §558.550.
(xiii) Zoalene alone and with arsanilic acid or roxarsone as in §558.680.
[41 FR 10994, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.78, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.95 Bambermycins.
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(a) Approvals. To sponsors identified by drug labeler codes in §510.600(c) of this chapter for use of bambermycins Type A medicated articles as bambermycins activity per pound in paragraph (d) of this section as follows:
(1) To 016592: 2, 4, and 10 grams for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section.
(2) To 016592: 0.4 gram for use as in paragraph (d)(2) of this section.
(3) [Reserved]
(4) To 016968, 017519, and 017790: 0.4 and 2 grams for use as in paragraph (d)(2) and 2 grams for use as in paragraph (d)(3) of this section.
(5) To 016592: 10 grams to make 40 to 800 grams per ton Type B feed for use as in paragraph (d)(4) of this section.
(b) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent.
(2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture.
(c) [Reserved]
(d) Conditions of use—(1) Broiler chickens. It is used as follows:
(i) Amount per ton. 1 to 2 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency.
(b) Limitations. Feed continuously as the sole ration.
(ii) [Reserved]
(2) Growing-finishing swine. It is used as follows:
(i) Amount per ton. 2 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency.
(b) Limitations. Feed continuously as sole ration.
(ii) Amount per ton. 2 to 4 grams.
(a) Indications for use. For increased rate of weight gain.
(b) Limitations. Feed continuously as sole ration.
(3) Growing turkeys. It is used as follows:
(i) Amount per ton. 1 to 2 grams.
(a) Indications for use. For improved feed efficiency.
(b) Limitations. Feed continuously as the sole ration.
(ii) Amount per ton. 2 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency.
(b) Limitations. Feed continuously as sole ration.
(4) Cattle—(i) Amount per ton. 1 to 4 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency.
(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously in a Type C medicated feed at a rate of 10 to 20 milligrams of bambermycins per head per day. Liquid Type B feeds containing bambermycins may be used in the preparation of dry complete ration Type C feeds.
(ii) Amount per ton. 2 to 40 grams.
(a) Indications for use. For increased rate of weight gain.
(b) Limitations. Feed continuously to pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) at a rate of 10 to 40 milligrams of bambermycins per head per day in at least 1 pound and not more than 10 pounds of Type C medicated feed. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.
(iii) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) as follows:
(a) Specifications.
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------------------------------------------------------------------------ International Feed Ingredient No. Percent------------------------------------------------------------------------Deflorinated phosphate (20.5% 6-01-080.......... 42.50 calcium, 18.5% phosphorus).Sodium chloride (salt).......... 6-04-152.......... 20.10Calcium carbonate (38% calcium). 6-01-069.......... 15.24Corn distillers dried grains w/ 5-28-236.......... 9.57 solubles.Magnesium oxide................. 6-02-756.......... 5.15Vitamin and trace mineral premix .................. 3.72 *.Mineral oil..................... .................. 1.00Yeast (primary dehydrated yeast) 7-05-533.......... 0.75Bambermycins Type A article (10 .................. 0.60 g/lb).Iron oxide...................... 6-02-431.......... 0.50Magnesium sulfate (67%)......... 6-02-758.......... 0.32Selenium premix (270 mg/lb) *... .................. 0.21Copper sulfate.................. 6-01-720.......... 0.18Potassium sulfate (0.33%)....... 6-06-098.......... 0.16------------------------------------------------------------------------*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
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(b) Amount per ton. 120 grams.
(c)Indications for use. For increased rate of weight gain.
(d) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Each use of this free-choice Type C medicated feed must be the subject of an approved Form FDA 1900 as required by 21 CFR 510.455.
(iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) as follows:
(a) Amount. Feed continuously to provide 10 to 40 milligrams of bambermycins per head per day.
(b) Indications for use. For increased rate of weight gain.
(c) Limitations. Each use in a free-choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supplemental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.
(5) Bambermycins may also be used in combination with:
(i) Amprolium alone or with roxarsone as in §558.55.
(ii) Amprolium and ethopabate alone or with roxarsone as in §558.58.
(iii) Diclazuril as in §558.198.
(iv) Halofuginone as in §558.265.
(v) Lasalocid alone or with roxarsone as in §558.311.
(vi) Monensin alone or with roxarsone as in §558.355.
(vii) Narasin alone or with nicarbazin or roxarsone as in §558.363.
(viii) Nicarbazin as in §558.366.
(ix) Salinomycin alone or with roxarsone as in §558.550.
(x) Zoalene alone or with roxarsone as in §558.680.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.95, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.105 [Reserved]
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§ 558.115 Carbadox.
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(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound) to 066104 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.100 of this chapter.
(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(d) Conditions of use. It is used for swine as follows:
(1) Amount per ton. 10–25 grams (0.0011–0.00275 percent).
(i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency.
(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.
(2) Amount per ton. 50 grams (0.0055 percent).
(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.
(3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent).
(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.
(ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein.
(4) Amount. Carbadox, 10 to 25 grams per ton of feed; plus oxytetracycline, 10 milligrams per pound of body weight.
(i) Indications for use. For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis susceptible to oxytetracycline, for treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Feed continuously for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.
[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004]
§ 558.120 Carbarsone (not U.S.P.).
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(a) Approvals. Type A medicated articles: (1) 37.5 percent to 046573 in §510.600(c) of this chapter.
(2) 25 percent carbarsone and 5 grams per pound bacitracin (as bacitracin methylene disalicylate) to 046573 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.60 of this chapter.
(c) [Reserved]
(d) Conditions of use. (1) It is used for turkeys as follows:
(i) Grams per ton. 227 to 340.5 (0.025 to 0.0375 percent).
(a) Indications for use. As an aid in the prevention of blackhead.
(b) Limitations. Feed continuously beginning 2 weeks before blackhead is expected and continue as long as prevention is needed; withdraw 5 days before slaughter; as sole source of organic arsenic.
(ii) Grams per ton. 227 to 340.5 (0.025 to 0.0375 percent) carbarsone plus 10 grams per ton bacitracin from bacitracin methylene disalicylate.
(a) Indications for use. As an aid in the prevention of blackhead; for increased rate of weight gain.
(b) Limitations. Feed continuously beginning 2 weeks before blackhead is expected and continue as long as prevention is needed; withdraw 5 days before slaughter; as sole source of organic arsenic.
(iii) Grams per ton. 227 to 340.5 (0.025 to 0.0375 percent) carbarsone plus 4 to 45 grams per ton bacitracin from bacitracin zinc.
(a) Indications for use. As an aid in the prevention of blackhead, increased rate of weight gain, and improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Withdraw 5 days before slaughter. As sole source of organic arsenic; as bacitracin zinc provided by No. 046573 in §510.600(c) of this chapter.
(iv) Grams per ton. 227 carbarsone, plus 1 or 4 grams per ton bambermycins.
(a) Indications for use. As an aid in the prevention of blackhead; and for increased rate of weight gain (4 grams per ton bambermycins) or improved feed efficiency (1 gram per ton bambermycins).
(b) Limitations. Feed continuously 2 weeks before blackhead is expected and continue as long as prevention is needed. Withdraw 5 days before slaughter. As sole source of organic arsenic. Bambermycins provided by No. 046573 in §510.600(c) of this chapter.
(2) Carbarsone (not U.S.P.) may be used in accordance with the provisions of this section in the combinations provided as follows:
(i) Zoalene in accordance with §558.680.
(ii) Amprolium as in §558.55.
[41 FR 10995, Mar. 15, 1976, as amended at 42 FR 18617, Apr. 8, 1977; 46 FR 46797, Sept. 22, 1981; 48 FR 2758, Jan. 21, 1983; 51 FR 7396, Mar. 3, 1986; 52 FR 2687, Jan. 26, 1987; 53 FR 20843, June 7, 1988; 57 FR 7652, Mar. 4, 1992; 61 FR 515, Jan. 8, 1996; 61 FR 18082, Apr. 24, 1996; 62 FR 61011, Nov. 14, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 71 FR 27956, May 15, 2006]
§ 558.128 Chlortetracycline.
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(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride or, for products intended for use in milk replacer, chlortetracycline hydrochloride.
(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) Nos. 046573, 048164, and 066104: 50 to 100 grams per pound (g/lb) of Type A medicated article.
(2) No. 017519: 50 g/lb of Type A medicated article.
(c) Related tolerances. See §556.150 of this chapter.
(d) Special considerations. (1) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”
(2) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to §510.455 of this chapter.
(3) When manufactured for use as in paragraph (e)(5)(iv) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”
(e) Conditions of use—(1) Chickens. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton...................... Chickens: For increased rate ............................. 046573. of weight gain and improved ............................. ........ feed efficiency.. Do not feed to chickens 017519, producing eggs for human 046573, consumption.. 048164, 066104.(ii) 100 to 200 g/ton................... Chickens: For control of 1. Feed continuously for 7 to 046573. infectious synovitis caused 14 d.. ........ by Mycoplasma synoviae ............................. 017519, susceptible to 2. Feed continuously for 7 to 046573, chlortetracycline.. 14 d; do not feed to 048164, chickens producing eggs for 066104. human consumption..(iii) 200 to 400 g/ton.................. Chickens: For the control of 1. Feed continuously for 7 to 046573. chronic respiratory disease 14 d.. ........ (CRD) and air sac infection ............................. 017519, caused by M. gallisepticum 2. Feed continuously for 7 to 046573, and Escherichia coli 14 d; do not feed to 048164, susceptible to chickens producing eggs for 066104. chlortetracycline.. human consumption..(iv) 500 g/ton.......................... Chickens: For the reduction 1. Feed for 5 d; 0-day 046573. of mortality due to E. coli withdrawal time when ........ infections susceptible to formulated from AUREOMYCIN ........ chlortetracycline.. Type A medicated articles or ........ Type B medicated feeds under 017519, NADA 48-761.. 046573, 2. Feed for 5 d; withdraw 24 048164, h prior to slaughter; do not 066104. feed to chickens producing eggs for human consumption..----------------------------------------------------------------------------------------------------------------
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(2) Turkeys. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton...................... Growing turkeys: For increased Do not feed to turkeys 017519, rate of weight gain and producing eggs for human 046573, improved feed efficiency.. consumption.. 048164, 066104.(ii) 200 g/ton.......................... Turkeys: For control of Feed continuously for 7 to 017519, infectious synovitis caused 14 d; do not feed to 046573, by M. synoviae susceptible to turkeys producing eggs for 048164, chlortetracycline.. human consumption.. 066104.(iii) 400 g/ton......................... 1. Turkeys: For control of Feed continuously for 7 to 017519, hexamitiasis caused by 14 d; do not feed to 046573, Hexamita meleagrides turkeys producing eggs for 048164, susceptible to human consumption.. 066104. chlortetracycline.. .............................. ........................... ......... 2. Turkey poults not over 4 017519, weeks of age: For reduction 046573, of mortality due to 048164, paratyphoid caused by 066104. Salmonella typhimurium susceptible to chlortetracycline..(iv) 25 mg/lb of body weight............ Turkeys: For control of Feed continuously for 7 to 017519, complicating bacterial 14 d; do not feed to 046573, organisms associated with turkeys producing eggs for 048164, bluecomb (transmissible human consumption.. 066104. enteritis; coronaviral enteritis) susceptible to chlortetracycline..----------------------------------------------------------------------------------------------------------------
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(3) Swine. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton...................... Growing swine: For increased ........................... 017519, rate of weight gain and 046573, improved feed efficiency.. 048164, 066104.(ii) 50 to 100 g/ton.................... Swine: For reducing the ........................... 017519, incidence of cervical 046573, lymphadenitis (jowl 048164, abscesses) caused by Group E. 066104. Streptococci susceptible to chlortetracycline..(iii) 400 g/ton......................... Breeding swine: For the Feed continuously for not 017519, control of leptospirosis more than 14 d.. 046573, (reducing the incidence of 048164, abortion and shedding of 066104. leptospirae) caused by Leptospira pomona susceptible to chlortetracycline..(iv) 10 mg/lb of body weight............ 1. Swine: For the treatment of Feed approximately 400 g/t, 017519, bacterial enteritis caused by varying with body weight 046573, E. coli and S. choleraesuis and feed consumption to 048164, and bacterial pneumonia provide 10 mg/lb per day. 066104. caused by Pasteurella Feed for not more than 14 multocida susceptible to d; withdraw 5 d prior to chlortetracycline.. slaughter for sponsor 017519.. .............................. ........................... ......... 2. Swine: For the control of Feed for not more than 14 046573. porcine proliferative d.. enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline..----------------------------------------------------------------------------------------------------------------
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(4) Cattle. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.1 mg/lb of body weight daily...... Calves (up to 250 lb): For See paragraph (d)(1) of 017519, increased rate of weight gain this section.. 046573, and improved feed efficiency.. 048164, 066104.(ii) 0.5 mg/lb of body weight daily..... Beef cattle (over 700 lb); Withdraw 48 h prior to 017519, control of active infection slaughter. To sponsor Nos. 046573, of anaplasmosis caused by 046573 and 048164: zero 048164, Anaplasma marginale withdrawal time.. 066104. susceptible to chlortetracycline..(iii) 0.5 to 2.0 mg/lb of body weight Beef cattle and nonlactating In free-choice cattle feeds 046573. daily.. dairy cattle: As an aid in such as feed blocks or the control of active salt-mineral mixes infection of anaplsmosis manufactured from approved caused by A. marginale Type A articles. See susceptible to paragraph (d)(2) of this chlortetracycline.. section..(iv) 10 mg/lb of body weight daily...... 1. Calves, beef and Feed approximately 400 g/ 017519, nonlactating dairy cattle; ton, varying with body 046573, treatment of bacterial weight and feed 048164, enteritis caused by E. coli consumption to provide 10 066104. and bacterial pneumonia mg/lb per day. Treat for caused by P. multocida not more than 5 d; in feed organisms susceptible to including milk replacers; chlortetracycline.. withdraw 10 d prior to slaughter. To sponsor Nos. 046573 and 048164: zero withdrawal time. To sponsor No. 046573: zero withdrawal time. See paragraph (d)(1) of this section.. .............................. ........................... ......... 2. Calves (up to 250 lb): For See paragraph (d)(1) of 017519, the treatment of bacterial this section.. 046573, enteritis caused by E. coli 048164, susceptible to 066104. chlortetracycline..(v) 500 to 4,000 g/ton.................. Calves, beef and nonlactating Hand feed continuously for 046573. dairy cattle; treatment of not more than 5 days to bacterial enteritis caused by provide 10 mg/lb body E. coli and bacterial weight per day.. pneumonia caused by P. multocida organisms susceptible to chlortetracycline..(vi) 4,000 to 20,000 g/ton.............. Calves, beef and nonlactating As a top dress, varying 046573. dairy cattle; treatment of with body weight and feed bacterial enteritis caused by consumption, to provide 10 E. coli and bacterial mg/lb per day. Treat for pneumonia caused by P. not more than 5 days. See multocida organisms paragraph (d)(1) of this susceptible to section.. chlortetracycline..(vii) 25 to 70 mg/head/day.............. Calves (250 to 400 lb): For See paragraph (d)(1) of 017519, increased rate of weight gain this section.. 046573, and improved feed efficiency.. 048164, 066104.(viii) 70 mg/head/day................... Growing cattle (over 400 lb): See paragraph (d)(1) of 017519, For increased rate of weight this section.. 046573, gain, improved feed 048164, efficiency, and reduction of 066104. liver condemnation due to liver abscesses..(ix) 350 mg/head/day.................... 1. Beef cattle: For control of Withdraw 48 h prior to 017519, bacterial pneumonia slaughter. To sponsor Nos. 046573, associated with shipping 046573 and 048164: zero 048164, fever complex caused by withdrawal time.. 066104. Pasteurellaspp. susceptible to chlortetracycline.. .............................. ........................... ......... 2. Beef cattle (under 700 lb): Withdraw 48 h prior to 017519, For control of active slaughter. To sponsor Nos. 046573, infection of anaplasmosis 046573 and 048164: zero 048164, caused by A. marginale withdrawal time.. 066104. susceptible to chlortetracycline..----------------------------------------------------------------------------------------------------------------
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(5) Minor species. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 20 to 50 g/ton...................... Growing sheep; increased rate ........................... 046573, of weight gain and improved 048164, feed efficiency.. 066104.(ii) 80 mg/head/day..................... Breeding sheep; reducing the ........................... 046573, incidence of (vibrionic) 048164, abortion caused by 066104. Campylobacter fetus infection susceptible to chlortetracycline..(iii) 200 to 400 g/ton.................. Ducks: For the control and Feed in complete ration to 046573. treatment of fowl cholera provide from 8 to 28 mg/lb caused by P. multocida of body weight per day susceptible to depending upon age and chlortetracycline.. severity of disease, for not more than 21 d. Do not feed to ducks producing eggs for human consumption..(iv) 10 mg/g of finished feed daily..... Psittacine birds (cockatoos, Feed continuously for 45 d; 046573. macaws, and parrots) each bird should consume suspected or known to be daily an amount of infected with psittacosis medicated feed equal to caused by Chlamydia psittaci one fifth of its body sensitive to weight.. chlortetracycline.. ........................... See paragraph (d)(3) of this section..----------------------------------------------------------------------------------------------------------------
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(6) Chlortetracycline. It may be used in accordance with this section in combinations as follows:
(i) Amprolium in accordance with §558.55.
(ii) Amprolium plus ethopabate in accordance with §558.58.
(iii) Bacitracin methylene disalicylate in accordance with §558.76.
(iv) Clopidol in accordance with §558.175.
(v) Decoquinate in accordance with §558.195.
(vi) Hygromycin B in accordance with §558.274.
(vii) Laidlomycin in accordance with §558.305.
(viii) Lasalocid in accordance with §558.311.
(ix) Monensin in accordance with §558.355.
(x) Robenidine hydrochloride in accordance with §558.515.
(xi) Roxarsone in accordance with §558.530.
(xii) Salinomycin alone or with roxarsone in accordance with §558.550.
(xiii) Tiamulin in accordance with §558.600.
(xiv) Zoalene in accordance with §558.680.
[41 FR 10995, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.128, see the List of Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.140 Chlortetracycline and sulfamethazine.
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(a) Approvals. Type A medicated articles: 35 grams of chlortetracycline per pound with 7.7 percent (35 grams) of sulfamethazine to Nos. 046573 and 048164 in §510.600(c) of this chapter.
(b) Related tolerances. See §§556.150 and 556.670 of this chapter.
(c) It is used in feed for beef cattle as follows:
(1) Amount per head per day. Chlortetracycline, 350 milligrams plus sulfamethazine, 350 milligrams.
(2) Indications for use. Aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.
(3) Limitations. Feed for 28 days; withdraw 7 days prior to slaughter.
[61 FR 35954, July 9, 1996, as amended at 64 FR 15684, Apr. 1, 1999; 66 FR 46706, Sept. 7, 2001; 68 FR 22294, Apr. 28, 2003; 69 FR 62407, Oct. 26, 2004]
§ 558.145 Chlortetracycline, procaine penicillin, and sulfamethazine.
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(a) Approvals. Type A medicated articles: (1) 20 grams of chlortetracycline per pound, 4.4 percent (20 grams) of sulfamethazine, and procaine penicillin equivalent in activity to 10 grams of penicillin per pound to 046573 in §510.600(c) of this chapter.
(2) 40 grams of chlortetracycline per pound, 8.8 percent of sulfamethazine, and penicillin procaine equivalent in activity to 20 grams of penicillin per pound to 046573 and 048164 in §510.600(c) of this chapter.
(b) Specifications. (1) The antibiotic substance refers to the antibiotic or feed-grade antibiotic.
(2) The antibiotic activities are expressed in terms of the appropriate antibiotic standards.
(3) Type C medicated feed contains in each ton, 100 grams of chlortetracycline, 50 grams of penicillin as procaine penicillin, and 100 grams of sulfamethazine.
(c) Related tolerances. See §§556.150, 556.510, and 556.670 of this chapter.
(d) Conditions of use. (1) It is administered to swine in a Type C feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; maintenance of weight gains in the presence of atrophic rhinitis; growth promotion and increased feed efficiency in swine weighing up to 75 pounds.
(2) Withdraw 15 days prior to slaughter.
[40 FR 13959, Mar. 27, 1975, as amended at 43 FR 19385, May 5, 1978; 47 FR 39814, Sept. 10, 1982; 48 FR 30615, July 5, 1983; 51 FR 7396, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 56 FR 14019, Apr. 5, 1991; 61 FR 18082, Apr. 24, 1996; 62 FR 14300, Mar. 26, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 47237, Aug. 8, 2003; 69 FR 62407, Oct. 26, 2004]
§ 558.155 Chlortetracycline, sulfathiazole, penicillin.
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(a) Approvals. Type A medicated articles: (1) 20 grams of chlortetracycline hydrochloride, 4.4 percent (20 grams) sulfathiazole, and procaine penicillin equivalent to 10 grams of penicillin per pound to No. 046573 in §510.600(c) of this chapter.
(2) 40 grams of chlortetracycline hydrochloride, 8.8 percent (40 grams) sulfathiazole and procaine penicillin equivalent in activity to 20 grams of penicillin per pound to No. 046573 in §510.600(c) of this chapter.
(b) Specifications. (1) The antibiotic substance refers to the antibiotic or feed-grade antibiotic.
(2) The antibiotic activities are expressed in terms of the appropriate antibiotic standards.
(c) Related tolerances. See §§556.150, 556.510, and 556.690 of this chapter.
(d) Conditions of use. It is used for swine as follows:
(1) Amount per ton. Chlortetracycline, 100 grams plus penicillin, 50 grams plus sulfathiazole, 100 grams.
(2) Indications for use. For reduction of incidence of cervical abscesses. Treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery). Maintenance of weight gains in the presence of atrophic rhinitis. Swine 10 pounds of body weight to 6 weeks post-weaning: Increased rate of weight gain and improved feed efficiency. Swine 6 to 16 weeks post-weaning: Increased rate of weight gain.
(3) Limitations. For swine raised in confinement (dry-lot) or on limited pasture. Feed as sole ration. Withdraw 7 days prior to slaughter.
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Minimum Amount of Type C Feed Which the Animal Should Consume------------------------------------------------------------------------ Minimum Approximate desired Type of feed body weight daily feed in pounds intake in pounds------------------------------------------------------------------------Prestarter (up to 6 weeks postweaning)......... 20 1Starter (up to 6 weeks postweaning)............ 50 1\1/2\Grower (6-16 weeks postweaning)................ 80 2Finisher (6-16 weeks postweaning).............. 150 3------------------------------------------------------------------------
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[40 FR 13959, Mar. 27, 1975, as amended at 51 FR 7397, Mar. 3, 1986; 51 FR 28547, Aug. 8, 1986; 52 FR 2684, Jan. 26, 1987; 61 FR 2415, Jan. 26, 1996; 62 FR 35077, June 30, 1997; 62 FR 67725, Dec. 30, 1997; 63 FR 11599, Mar. 10, 1998; 66 FR 46706, Sept. 7, 2001; 67 FR 21171, Apr. 30, 2002]
§ 558.175 Clopidol.
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(a) Specifications. Type A medicated article containing 25 percent clopidol.
(b) Approvals. See No. 050604 in §510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams Clopidol in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(1) 113.5........................ .................... Broiler chickens and re- Do not feed to 050604 placement chickens chickens over 16 intended for use as weeks of age. caged layers: As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.(2) 113.5........................ Bacitracin methylene Broiler chickens: As in Feed continuously 050604 disalicylate 4 to paragraph (d)(1) of as the sole ration 50. this section; for from the time increased rate of chicks are placed weight gain. in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter.(3) 113.5........................ Bacitracin 4 to 25 Broiler chickens: As in Do not feed to 046573, plus roxarsone 45.4. paragraph (d)(1) of chickens over 16 050604 this section; for weeks of age; growth promotion, feed withdraw 5 days efficiency; improved before slaughter; pigmentation, and as sole source of increased rate of organic arsenic; weight gain. as bacitracin methylene disalicylate or bacitracin zinc provided by No. 046573 in § 510.600(c) of this chapter.(4) 113.5........................ Bacitracin zinc 5 to Broiler chickens: As in Feed continuously 046573, 25. paragraph (d)(1) of as sole ration; 050604 this section; for bacitracin zinc as increased rate of provided by No. weight gain and 046573 in § improved feed 510.600(c) of this efficiency. chapter.(5) 113.5........................ Chlortetracycline Broiler and replacement Feed continuously 050604 100 to 200. chickens: As in as sole ration paragraph (d)(1) of from the time this section; for chicks are placed control of infectious in floor pens for synovitis caused by 7 to 14 days. Mycoplasma synoviae susceptible to chlortetracycline.(6) 113.5........................ Lincomycin 2 to 4... Broiler chickens: As in Do not feed to 000009 paragraph (d)(1) of chickens over 16 this section; for weeks of age; as increased rate of lincomycin weight gain and hydrochloride improved feed monohydrate. efficiency.(7) 113.5........................ Roxarsone 45.4...... Broiler and replacement Do not feed to 050604 chickens intended for chickens over 16 use as caged layers: weeks of age; As in paragraph (d)(1) withdraw 5 days of this section; for before slaughter; growth promotion, feed as sole source of efficiency; and organic arsenic. improved pigmentation.(8) 227.......................... .................... Broiler and replacement Feed continuously 050604 chickens intended for as the sole use as caged layers: ration; feed up to As in paragraph (d)(1) 16 weeks of age if of this section. intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter.(9) 113.5 or 227................. .................... Turkeys: As an aid in For turkeys grown 050604 the prevention of for meat purposes leucocytozoonosis only; feed caused by continuously as Leucocytozoon smithi. the sole ration at 0.0125 or 0.025 percent clopidol depending on management practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter.----------------------------------------------------------------------------------------------------------------
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[68 FR 17882, Apr. 14, 2003]
§ 558.185 Coumaphos.
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(a) Specifications. Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos.
(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) No. 000859 for use of Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos as in paragraphs (e)(2) and (e)(3) of this section.
(2) No. 017800 for use of Type A medicated articles containing 11.2 percent coumaphos as in paragraph (e)(1) of this section.
(3) No. 051311 for use of Type A medicated articles containing 1.12 percent coumaphos as in paragraph (e)(1) of this section.
(c) Related tolerances. See 40 CFR 180.189.
(d) Special considerations. Labeling shall bear the following caution statement: “The active ingredient coumaphos is a cholinesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.” Also, see §500.25 of this chapter.
(e) Conditions of use—(1) Beef and dairy cattle—(i) Amount. 0.0002 lb. (0.091 gram) per 100 lb. body weight per day for 6 consecutive days. Should conditions warrant, repeat treatment at 30-day intervals.
(ii) Indications for use. Control of gastrointestinal roundworms (Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Trichostrongylus spp.).
(iii) Limitations. Feed in the normal grain ration to which the animals are accustomed, but not in rations containing more than 0.1 percent coumaphos. Do not feed to animals less than 3 months old. Do not feed to sick animals or animals under stress, such as those just shipped, dehorned, castrated, or weaned within the last 3 weeks. Do not feed in conjunction with oral drenches or with feeds containing phenothiazine.
(2) Laying chickens—(i) Amount. Coumaphos 27.2 grams per ton (0.003 percent).
(ii) Indications for use. For control of capillary worm (Capillaria obsignata) and as an aid in control of common round worm (Ascaridia galli) and cecal worm (Heterakis gallinae).
(iii) Limitations. In Type C feed; administer continuously as the total feed ration for 14 days; when reinfection occurs, treatment may be repeated but not sooner than 3 weeks after the end of the previous treatment; do not feed to chickens within 10 days of vaccination or other conditions of stress; treatment of colored breeds of commercial layers should be avoided while in production since these breeds appear to be more sensitive to coumaphos than white breeds; as sole medication; medications in general should be avoided while birds are approaching peak production; such interruption of normal feeding practices may upset the flock and lower egg production; diagnosis by competent personnel is essential; flock condition and production records should be carefully evaluated prior to treatment.
(3) Replacement pullets—(i) Amount. Coumaphos 36.3 grams per ton (0.004 percent).
(ii) Indications for use. For control of capillary worm (Capillaria obsignata) and as an aid in control of common roundworm (Ascaridia galli) and cecal worm (Heterakis gallinae).
(iii) Limitations. In Type C feed; administer before the onset of production; diagnosis by competent personnel is essential; administer continuously as total feed ration for from 10 to 14 days; do not feed to chickens under 8 weeks of age nor within 10 days of vaccination or other conditions of stress; if birds are maintained on contaminated litter or exposed to infected birds, a second 10 to 14 day treatment is recommended but not sooner than 3 weeks after the end of the previous treatment; as sole medication; if reinfection occurs after production begins, repeat treatment as recommended for laying flocks.
[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 1463, Jan. 7, 1977; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 61 FR 34729, July 3, 1996; 69 FR 70056, Dec. 2, 2004; 70 FR 32489, June 3, 2005]
§ 558.195 Decoquinate.
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(a) Specifications. Type A medicated article containing 6 percent decoquinate.
(b) Approvals. See No. 046573 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.170 of this chapter.
(d) Special considerations. (1) Bentonite should not be used in decoquinate feeds.
(2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section.
(3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises.
(e) Conditions of use. It is used as follows:
(1) Chickens.
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---------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 27.2......................... .................... Broiler chickens: For Do not feed to 046573 prevention of laying chickens.. coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati,E. acervulina, E. maxima, and E. brunetti..(ii) 27.2........................ Bacitracin methylene Broiler chickens: As in Feed continuously 046573 disalicylate 4 to paragraph (e)(1)(i) of as sole ration; do 50. this section; and for not feed to laying increased rate of chickens. weight gain and Bacitracin improved feed methylene efficiency.. disalicylate as provided by No. 046573 in § 510.600(c) of this chapter..(iii) 27.2....................... Bacitracin zinc 10 Broiler chickens: As in Feed continuously 046573 to 50. paragraph (e)(1)(ii) as sole ration; do of this section.. not feed to laying chickens. Bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter..(iv) 27.2........................ Bacitracin zinc 12 Broiler chickens: As in Do not feed to 046573 to 50 plus paragraph (e)(1)(ii) laying chickens; roxarsone 11 to 45. of this section.. withdraw 5 days before slaughter; as sole source of organic arsenic.. .................... ....................... Bacitracin zinc and ......... roxarsone as provided by No. 046573 in § 510.600(c) of this chapter..(v) 27.2......................... Bacitracin methylene Broiler chickens: As in Feed continuously 046573 disalicylate 50 and paragraph (e)(1)(ii) as sole ration; do roxarsone 22.7 to of this section; as an not feed to laying 45.4. aid in the prevention chickens; withdraw of necrotic enteritis 5 days before caused or complicated slaughter. Not for by Clostridium spp. or use in breeder other organisms chickens. Use as susceptible to sole source of bacitracin; and for organic arsenic. improved pigmentation.. Poultry should have access to drinking water at all times. Drug overdosage or lack of drinking water may result in leg weakness or paralysis.. Bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter..(vi) 27.2........................ Chlortetracycline Chickens: As in Feed continuously 046573 100 to 200. paragraph (e)(1)(i) of for 7 to 14 days; this section; control do not feed to of infectious chickens producing synovitis caused by eggs for human Mycoplasma synoviae consumption.. susceptible to chlortetracycline..(vii) 27.2....................... Chlortetracycline Chickens: As in As in paragraph 046573 200 to 400. paragraph (e)(1)(i) of (e)(1)(vi) of this this section; and for section.. control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline..(viii) 27.2...................... Lincomycin 2........ Broiler chickens: As in Feed as sole 000009 paragraph (e)(1)(ii) ration; do not 046573 of this section.. feed to laying chickens; lincomycin provided by No. 000009 in § 510.600(c) of this chapter..(ix) 27.2........................ Roxarsone 45.4...... Broiler chickens: As in Do not feed to 046573 paragraph (e)(1)(ii) laying chickens; of this section; and withdraw 5 days for improving before slaughter; pigmentation.. as sole source of organic arsenic..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 12.9 to 90.8................. .................... Cattle (including Feed Type C feed or 046573 ruminating and milk replacer to nonruminating calves provide 22.7 and veal calves): For milligrams (mg) prevention of per 100 pounds coccidiosis caused by (lb) of body Eimeria bovis and E. weight (0.5 mg/kg) zuernii. per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section..(ii) 12.9 to 90.8................ Chlortetracycline Calves, beef, and Feed Type C feed to 046573 500 to 4,000.. nonlactating dairy provide 22.7 mg cattle: As in decoquinate and 1 paragraph (e)(2)(i) of gram this section; for chlortetracycline treatment of bacterial per 100 lb body enteritis caused by weight per day for Escherichia coli; and not more than 5 for treatment of days. When bacterial pneumonia consumed, feed caused by Pasteurella 22.7 mg multocida organisms decoquinate per susceptible to 100 lb body weight/ chlortetracycline.. day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline ) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline ) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this chapter..(iii) 12.9 to 90.8............... Monensin 5 to 30.... Cattle fed in Feed only to cattle 046573 confinement for fed in confinement slaughter: As in for slaughter. paragraph (e)(2)(i) of Feed continuously this section; and for as the sole ration improved feed to provide 22.7 mg efficiency.. of decoquinate per 100 lb body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(8). Monensin as provided by No. 000986 in § 510.600(c) of this chapter..(iv) 13.6 to 27.2................ Chlortetracycline Calves, beef and Feed Type C feed to 046573 approximately 400 nonlactating dairy provide 22.7 mg 048164 (varying with body cattle: As in decoquinate and 1 weight and feed paragraph (e)(2)(i) of gram (g) consumption to this section; for chlortetracycline provide 10 mg/lb of treatment of bacterial per 100 lb body body weight per enteritis caused by E. weight (0.5 mg/kg) day). coli; and for per day for not treatment of bacterial more than 5 days. pneumonia caused by Type C feed may be Pasteurella multocida prepared from Type organisms susceptible B feed containing to chlortetracycline.. 535.8 to 5,440 g/ ton decoquinate and 6,700 to 80,000 g/ton chlortetracycline. When consumed, feed 22.7 mg decoquinate per 100 lb body weight/ day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from chlortetracycline Type A medicated articles under NADA 141-147 and ANADA 200-359. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline ) Type A medicated articles under NADA 141-185. Do not feed to calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by Nos. 046573 and 048164 in § 510.600(c) of this chapter..(v) 13.6 to 27.2................. Monensin 5 to 30 Cattle fed in Feed only to cattle 046573 plus tylosin 8 to confinement for fed in confinement 10. slaughter: As in for slaughter. paragraph (e)(2)(i) of Feed continuously this section; for as the sole ration improved feed to provide 22.7 mg efficiency; and for of decoquinate per reduction of incidence 100 lb body weight of liver abscesses per day, 50 to 360 caused by mg of monensin per Fusobacterium head per day, and necrophorum and 60 to 90 mg of Actinomyces tylosin per head (Corynebacterium) per day. Feed at pyogenes.. least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see paragraph (d)(1) of this section and § 558.355(d)(8). Monensin and tylosin as provided by No. 000986 in § 510.600(c) of this chapter..(vi) 90.9 to 535.7............... .................... Cattle (including Feed Type C 046573 ruminating and medicated feed nonruminating calves supplements as a and veal calves): As top dress or mix in paragraph (e)(2)(i) into the daily of this section.. ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section..(vii) 90.9 to 535.7.............. Chlortetracycline Calves, beef, and Feed Type C 046573 4,000 to 20,000.. nonlactating dairy medicated feed cattle: As in supplements as a paragraph (e)(2)(i) of top dress or mix this section; for into the daily treatment of bacterial ration to provide enteritis caused by 22.7 mg Escherichia coli; and decoquinate and 1 for treatment of gram bacterial pneumonia chlortetracycline caused by Pasteurella per 100 lb body multocida organisms weight per day for susceptible to not more than 5 chlortetracycline.. days. When consumed, feed 22.7 mg decoquinate per 100 lb body weight per day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline ) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline ) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this chapter..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 12.9 to 90.8................. .................... 1. Young sheep: For the Feed Type C feed or 046573 prevention of milk replacer at a coccidiosis caused by rate to provide Eimeria ovinoidalis, 22.7 mg per 100 lb E. crandallis, E. of body weight parva, and E. (0.5 mg per kg) bakuensis.. per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food.. .................... 2. Young goats: For the Feed Type C feed or prevention of milk replacer at a coccidiosis caused by rate to provide E. christenseni and E. 22.7 mg per 100 lb ninakohlyakimovae.. of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food..(ii) 90.9 to 535.7............... .................... 1. Young sheep: As in Feed Type C 046573 item 1 of paragraph medicated feed (e)(3)(i) of this supplements as a section.. top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food.. .................... 2. Young goats: As in Feed Type C ......... item 2 of paragraph medicated feed (e)(3)(i) of this supplements as a section.. top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food..----------------------------------------------------------------------------------------------------------------
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[67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005]
§ 558.198 Diclazuril.
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(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.
(b) Approvals. See No. 000061 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.185 of this chapter.
(d) Conditions of use. (1) Chickens. For chickens it is used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination grams/ Diclazuril grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.91 (1 part per million .................... Broiler chickens: For Feed continuously. 000061 (ppm)). the prevention of Not for use in coccidiosis caused by hens producing Eimeria tenella, E. eggs for human necatrix, E. food.. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima..(ii) 0.91 (1 ppm)................ Bacitracin methylene Broiler chickens: As in As in item (i) of 000061 disalicylate 4 to item (i) of this this table. 50. table; for increased Bacitracin rate of weight gain methylene and improved feed disalicylate efficiency.. provided by 046573..(iii) 0.91 (1 ppm)............... Bacitracin methylene Broiler chickens: As in Feed continuously 000061 disalicylate 50 item (i) of this as the sole ration plus roxarsone 22.7 table; as an aid in throughout growing to 45.4. the prevention of period. Use as necrotic enteritis sole source of caused or complicated organic arsenic; by Clostridium spp. or drug overdose or other organisms lack of water may susceptible to result in leg bacitracin; for weakness. Not for increased rate of use in hens weight gain, improved producing eggs for feed efficiency, and human consumption. improved pigmentation.. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter..(iv) 0.91 (1 ppm)................ Bacitracin methylene Broiler chickens: As in Feed continuously 000061 disalicylate 100 to item (i) of this as the sole ration 200 plus roxarsone table; as an aid in throughout growing 22.7 to 45.4. the control of period. Start at necrotic enteritis first clinical caused or complicated signs of disease; by Clostridium spp. or vary dosage of other organisms bacitracin based susceptible to on severity of bacitracin; for infection; increased rate of administer weight gain, improved continuously for 5 feed efficiency, and to 7 days or as improved pigmentation.. long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton (g/ton). Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter..(v) 0.91 (1 ppm)................. Bambermycins 1 to 2. Broiler chickens: As in As in item (i) of 000061 item (i) of this this table. table); for increased Bambermycins rate of weight gain provided by and improved feed 057926.. efficiency..(vi) 0.91(1 ppm)................. Roxarsone 22.7 to Broiler chickens: As in Feed continuously 046573 45.4. item (i) of this as the sole ration table; for increased throughout growing rate of weight gain, period. Use as improved feed sole source of efficiency, and organic arsenic; improved pigmentation.. drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter.. Roxarsone provided by No. 046573 in § 510.600(c) of this chapter..(vii) 0.91 (1 ppm)............... Virginiamycin 5..... Broiler chickens: As in As in item (i) of 000061 item (i) of this this table; table; for increased Virginiamycin rate of weight gain provided by and improved feed 066104.. efficiency..(viii) 0.91 (1 ppm).............. Virginiamycin 5 to Broiler chickens: As in As in item (i) of 000061 15. item (i) of this this table. table; for increased Virginiamycin rate of weight gain.. provided by 066104..----------------------------------------------------------------------------------------------------------------
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(2) Turkeys. For turkeys it is used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination grams/ Diclazuril grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.91 (1 ppm)................. .................... Growing turkeys: For Feed continuously 000061 the prevention of as the sole coccidiosis caused by ration. Do not E. adenoeides, E. feed to breeding gallopavonis and E. turkeys. Not for meleagrimitis.. use in hens producing eggs for human consumption..(ii) 0.91 (1 ppm)................ Bacitracin methylene Growing turkeys: As in As in paragraph 000061 disalicylate 4 to paragraph (d)(2)(i) of (d)(2)(i) of this 50.. this section; for section. increased rate of Bacitracin weight gain and methylene improved feed disalicylate efficiency.. provided by No. 046573 in § 510.600(c) of this chapter..(iii) 0.91 (1 ppm)............... Bambermycins 1 to 2. Growing turkeys: As in As in paragraph 000061 paragraph (d)(2)(i) of (d)(2)(i) of this this section; for section. improved feed Bambermycins efficiency.. provided by No. 057926 in § 510.600(c) of this chapter..(iv) 0.91 (1 ppm)................ Bambermycins 2...... Growing turkeys: As in As in paragraph 000061 paragraph (d)(2)(i) of (d)(2)(i) of this this section; for section. increased rate of Bambermycins weight gain and provided by No. improved feed 057926 in § efficiency.. 510.600(c) of this chapter..----------------------------------------------------------------------------------------------------------------
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[64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004]
§ 558.205 Dichlorvos.
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(a) Approvals. Type A medicated articles: 3.1 and 9.6 percent to 000010 in §510.600(c) of this chapter.
(b) Special considerations. (1) Dichlorvos is to be included in meal or mash or mixed with feed in crumble form only after the crumble feed has been manufactured. Do not mix in feeds to be pelleted nor with pelleted feed. Do not soak the feed or administer as wet mash. Feed must be dry when administered. Do not use in animals other than swine. Do not allow fowl access to feed containing this preparation or to feces from treated animals.
(2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is antidotal.
(3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used.
(c) Related tolerances. See §556.180 of this chapter.
(d) Conditions of use. It is used in feed for swine as follows:
(1) Amount per ton. Dichlorvos, 348 grams (0.0384 percent).
(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp. ), large roundworm (Ascaris suum) and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.
(ii) Limitations. For swine up to 70 pounds body weight, feed as sole ration for 2 consecutive days. For swine from 70 pounds to market weight, feed as sole ration at the rate of 8.4 pounds of feed per head until the medicated feed has been consumed. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days.
(2) Amount per ton. Dichlorvos, 479 grams (0.0528 percent).
(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp. ), large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.
(ii) Limitations. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 6 pounds per head for one feeding.
(3) Amount per ton. Dichlorvos, 334–500 grams (0.0366–0.0550 percent).
(i) Indications for use. An aid in improving litter production efficiency by increasing pigs born alive, birth weights, survival to market, and rate of weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm (Trichuris suis), nodular worm (Oesophagostomum supp. ) large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) occurring in the gastrointestinal tract of the sow or gilt.
(ii) Limitations. For pregnant swine; mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of gestation.
[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 50258, Oct. 29, 1975; 48 FR 46515, Oct. 13, 1983; 51 FR 7397, Mar. 3, 1986; 51 FR 28547, Aug. 8, 1986; 52 FR 2684, Jan. 26, 1987; 62 FR 35077, June 30, 1997]
§ 558.235 Efrotomycin.
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(a) Approvals. Type A medicated article: 14.5 grams per pound to 050604 in §510.600(c) of this chapter.
(b) Conditions of use—(1) Swine. (i) Amount. 3.6 grams per ton.
(A) Indications for use. For improved feed efficiency.
(B) Limitations. Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds.
(ii) Amount. 3.6 to 14.5 grams per ton.
(A) Indications for use. For increased rate of weight gain.
(B) Limitations. Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds.
(2) [Reserved]
[57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997]
§ 558.248 Erythromycin thiocyanate.
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(a) Approvals. Type A medicated articles: (1) 2.2 percent to 061623 in §510.600(c) of this chapter for use as in paragraph (d) of this section.
(2) 5 and 10 percent to 061623 for use in paragraphs (d)(1)(i) and (ii) of this section.
(b) Special considerations. The levels of antibiotic are expressed in terms of erythromycin master standard. One gram of erythromycin thiocyanate is equivalent to 0.925 gram of erythromycin master standard.
(c) Related tolerances. See §556.230 of this chapter.
(d) Condition of use. (1) It is used as follows:
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----------------------------------------------------------------------------------------------------------------Erythromycin thiocyanate in grams Combination in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 4.6 to 18.5.................. .................... Chickens; growth ................... , promotion and feed 061623 efficiency.(ii) 9.25 to 18.5................ .................... Turkeys; growth For turkeys not , promotion and feed over 12 weeks of 061623 efficiency. age.(iii) 9.25 to 64.75.............. .................... Swine; increase in Starter ration for 061623 weight gain, improved animals up to 35 feed efficiency in lb body weight. starter pigs (9.25 to 64.75) and grower- finishing pigs (9.25).(iv) 18.5........................ .................... Laying chickens; aids ................... 061623 in increasing egg production.(v) 92.5......................... .................... 1. Chickens; as an aid Feed for 2 d before 061623 in the prevention of stress and 3 to 6 chronic respiratory d after stress; disease during periods withdraw 24 h of stress. before slaughter. 2. Chickens; as an aid Feed for 7 to 14 d; in the prevention of withdraw 24 h infectious coryza. before slaughter. 3. Turkeys; as an aid Feed for 2 d before in the prevention of stress and 3 to 6 chronic respiratory d after stress. disease during periods of stress.(vi) 185......................... .................... 1. Chickens; as an aid Feed for 5 to 8 d; 061623 in the prevention and do not use in reduction of lesions birds producing and in lowering eggs for food severity of chronic purposes; withdraw respiratory disease. 48 h before slaughter. 2. Turkeys; as an aid Feed for 5 to 8 d; 061623 in the prevention and do not use in reduction of lesions birds producing and in lowering eggs for food severity of chronic purposes. respiratory disease.----------------------------------------------------------------------------------------------------------------
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(2) In feed for feedlot beef cattle at 37 milligrams per head per day as an aid in stimulating growth and improving feed efficiency.
(3) Erythromycin thiocyanate may be used in accordance with the provisions of this section in the combinations provided as follows:
(i) Amprolium in accordance with §558.55.
(ii) Amprolium and ethopabate in accordance with §558.58.
(iii) Arsanilic acid in accordance with §558.62.
(iv) Zoalene in accordance with §558.680.
[41 FR 10999, Mar. 15, 1976, as amended at 45 FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]
§ 558.254 Famphur.
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(a) Approvals. Type A medicated articles: 13.2 and 33.3 percent to 000061 in §510.600(c) of this chapter.
(b) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
(c) Related tolerances. See §556.273 of this chapter.
(d) Conditions of use. It is used in the feed for cattle as follows:
(1) Amount. 1.1 milligrams per pound body weight per day.
(i) Indications for use. For control of grubs and as an aid in control of sucking lice.
(ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 30 days; withdraw from dry dairy cows and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter.
(2) Amount. 2.3 milligrams per pound body weight per day.
(i) Indications for use. For control of grubs.
(ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 10 days; withdraw from dry dairy cows and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter.
[41 FR 11000, Mar. 15, 1976, as amended at 51 FR 7397, Mar. 3, 1986; 57 FR 7652, Mar. 4, 1992; 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997]
§ 558.258 Fenbendazole.
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(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole.
(b) Approvals. See No. 057926 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.275 of this chapter.
(d) Special considerations. See §500.25 of this chapter.
(e) Conditions of use—(1) Turkeys.
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---------------------------------------------------------------------------------------------------------------- Amount fenbendazole in grams per Combination in grams ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------14.5 (16 parts per million)...... .................... Growing turkeys: For Feed continuously 057926 the removal and as the sole ration control of for 6 days. For gastrointestinal growing turkeys worms: round worms, only. adult and larvae (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead).----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Amount fenbendazole in grams per Combination in grams ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 300 (to provide 9 .................... For the removal and Feed as sole ration 057926 milligrams per kilogram (mg/kg) control of: Adult of body weight) given over a 3- stage lungworms to 12-day period. (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages_liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages_intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus).(ii) 10 to 80 (to provide 9 mg/kg Lincomycin 20....... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not section; for increased feed to swine that rate of gain in weigh more than growing-finishing 250 pounds (lbs); swine. lincomycin as provided by 000009 in § 510.600(c) of this chapter.(iii) 10 to 80 (to provide 9 mg/ Lincomycin 40....... As in paragraph Feed as sole 057926 kg of body weight). (e)(2)(i) of this ration. Do not section; for control feed to swine that of swine dysentery in weigh more than animals on premises 250 lbs.; with a history of lincomycin as swine dysentery, but provided by 000009 where symptoms have in § not yet occurred. 510.600(c) of this chapter.(iv) 10 to 80 (to provide 9 mg/kg Lincomycin 100...... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not use section; for the within 6 days of treatment of swine slaughter. Do not dysentery. feed to swine that weigh more than 250 lbs.; lincomycin as provided by 000009 in § 510.600(c) of this chapter.(v) 10 to 80 (to provide 9 mg/kg Lincomycin 200...... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not use section; for reduction within 6 days of in the severity of slaughter. Do not swine mycoplasmal feed to swine that pneumonia caused by weigh more than Mycoplasma 250 pound (lb); hyopneumoniae. lincomycin as provided by 000009 in § 510.600(c) of this chapter.(vi) 10 to 300 (to provide 9 mg/ Bacitracin methylene Growing/finishing Feed as sole 046573 kg of body weight). disalicylate 10 to swine: As in paragraph ration. Under 30. (e)(2)(i) of this conditions of section; for increased continued exposure rate of weight gain to parasites, and improved feed retreatment may be efficiency. needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.(vii) 10 to 300 (to provide 9 mg/ Bacitracin methylene 1. Growing/finishing 1. Growing/ 046573 kg of body weight). disalicylate 250. swine: As in paragraph finishing swine: (e)(2)(i) of this Feed as sole section; for control ration. Not for of swine dysentery use in growing and associated with finishing swine Treponema that weigh more hyodysenteriae on than 250 lbs. premises with a Diagnosis of swine history of swine dysentery should dysentery, but where be confirmed by a signs of disease have veterinarian when not yet occurred; or results are not following an approved satisfactory. treatment of the Under conditions disease condition. of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter. .................... 2. Pregnant sows: As in 2. Pregnant sows: ......... paragraph (e)(2)(i) of Feed as sole this section; for ration. Diagnosis control of clostridial of clostridial enteritis in suckling enteritis should pigs caused by be confirmed by a Clostridium veterinarian when perfringens. results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.----------------------------------------------------------------------------------------------------------------
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(3) Cattle—(i) Conditions of use are as follows:
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----------------------------------------------------------------------------------------------------------------Amount fenbendazole in Combination in grams grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(A) 5 mg/kg body ....................... For the removal and Feed as sole ration for 057926 weight (2.27 mg/lb) control of lungworms one day. Do not use (Dictyocaulus within 13 days of viviparus); barberpole slaughter. worms (Haemonchus contortus); brown stomach worms (Ostertagia ostertagi); small stomach worms (Trichostrongylus axei); hookworms (Bunostomum phlebotomum); thread- necked intestinal worms (Nematodirus helvetianus); small intestinal worms (Cooperia oncophora and C. punctata), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).(B) 5 mg/kg body ....................... As in paragraph Formulate as specified in 057926 weight (2.27 mg/lb) (e)(3)(i)(A) of this paragraph (e)(3)(ii) of in a free-choice feed section. this section. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment may be needed after 4 to 6 weeks. Do not slaughter within 13 days following last treatment.----------------------------------------------------------------------------------------------------------------
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(ii) Formulate for use as a free-choice cattle feed as in paragraph (e)(3)(i)(B) of this section as follows:
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------------------------------------------------------------------------ International Ingredient\1\ Percent feed No.------------------------------------------------------------(A) Ingredient:................. ........... ............. Copper sulfate................. 0.45 6-01-720 Dried Cane Molasses............ 3.12 4-04-695 Monosodium phosphate........... 31.16 6-04-288 Salt (sodium chloride)......... 59.00 6-04-152 Zinc sulfate................... 0.76 6-05-556 Fenbendazole Type A article 5.51 ............. (20%)..........................(B) Ingredient:................. ........... ............. Dicalcium phosphate............ 32.31 6-00-080 Limestone...................... 17.13 6-02-632 Magnesium oxide................ 9.79 6-02-756 Zinc sulfate................... 1.47 6-05-556 Copper sulfate................. 0.29 6-01-720 Potassium iodide............... 0.0098 6-03-759 Dried Cane Molasses............ 0.98 4-04-695 Selenium....................... 0.0002 ............. Salt........................... 35.93 6-04-152 Fenbendazole Type A article 2.09 ............. (20%)..........................------------------------------------------------------------------------\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium must comply with published regulations.
---------------------------------------------------------------------------------------------------------------- Amount fenbendazole in grams per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 4,540............................. 5 mg/kg body weight (2.27 mg/ Feed at the rate of 0. 1lb of 057926 lb) for the control of large feed per 100 lb of body strongyles (Strongylus weight to provide 2.27 mg edentatus, S. equinus, S. fenbendazole/lb of body vulgaris, Triodontophorus weight in a 1-day treatment spp.), small strongyles or 0.2 lb of feed per 100 lb (Cyathostomum spp., of body weight to provide Cylicocyclus spp., 4.54 mg fenbendazole/lb of Cylicostephanus spp.), and body weight in a 1-day pinworms (Oxyuris equi); 10 treatment. All horses must mg/kg body weight (4.54 mg/ be eating normally to ensure lb) for the control of that each animal consumes an ascarids (Parascaris adequate amount of the equorum).. medicated feed. Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection. Do not use in horses intended for food..(ii) [Reserved]....................... .............................. ............................. .........----------------------------------------------------------------------------------------------------------------
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(5) Zoo and wildlife animals.
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---------------------------------------------------------------------------------------------------------------- Species/Class Amount fenbendazole Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) Feral swine (Sus scrofa)..... 3 mg/kg/day for 3 For the removal and Use as complete 057926 days.. control of kidney worm feed. Prior (Stephanurus withdrawal of feed dentatus), roundworm or water is not (Ascaris suum), necessary. nodular worm Retreatment may be (Oesophagostomum required in 6 dentatum). weeks. Do not use 14 days before or during the hunting season.(ii) Ruminants (subfamily 2.5 mg/kg/day for 3 For the removal and Use as complete 057926 Antilopinae, Hippotraginae, days.. control of small feed. Prior Caprinae). stomach worm withdrawal of feed (Trichostrongylus or water is not spp.), thread necked necessary. intestinal worm Retreatment may be (Nematodirus spp.), required in 6 barberpole worm weeks. Do not use (Haemonchus spp.), 14 days before or whipworm (Trichuris during the hunting spp.). season.(iii) Rocky mountain bighorn 10 mg/kg/day for 3 For the removal and Use as complete 057926 sheep (Ovis c. canadensis). days.. control of feed. Prior Protostrongylus spp. withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season.----------------------------------------------------------------------------------------------------------------
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[66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003]
§ 558.261 Florfenicol.
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(a) Specifications. Type A medicated article containing 500 grams florfenicol per kilogram.
(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.
(c) Special considerations—(1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See §558.6 of this chapter for additional requirements.
(2) The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 15 days from the date of issuance. VFDs for florfenicol shall not be refilled.
(d) Related tolerances. See §556.283 of this chapter.
(e) Conditions of use—(1) Catfish—(i) Amount. 10 milligrams per kilogram of fish daily for 10 consecutive days.
(ii) Indications for use. For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
(iii) Limitations. Feed containing florfenicol shall not be fed to catfish for more than 10 days. Following 10 days administration, fish should be re-evaluated by a licensed veterinarian before reinitiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for the hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 12 days prior to slaughter.
(2) [Reserved]
[70 FR 70047, Nov. 21, 2005]
§ 558.265 Halofuginone hydrobromide.
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(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.
(b) Approvals. See No. 016592 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.308 of this chapter.
(d) Conditions of use. (1) It is used in feed for broiler chickens as follows:
(i) Amount. 2.72 grams per ton.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.
(ii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bambermycins 1 to 2 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency.
(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers.
(iii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency.
(B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers.
(iv) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 to 15 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, and E. maxima; for increased rate of weight gain.
(B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers.
(v) Amount per ton. Halofuginone hydrobromide 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams and roxarsone 22.7 to 45.4 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain; and for improved feed efficiency.
(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; use as sole source of organic arsenic; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.
(vi) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, E. maxima and for improved feed efficiency.
(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.
(vii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus lincomycin 2 to 4 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency.
(B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.
(viii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus roxarsone, 22.7 to 45.4 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(B) Limitations. Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Use as the sole source of organic arsenic; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens or waterfowl. Withdraw 5 days before slaughter.
(2) It is used in feed for turkeys as follows:
(i) Amount per ton. 1.36 to 2.72 grams.
(A) Indications for use. For the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis.
(B) Limitations. Feed continuously as sole ration; withdraw 7 days before slaughter; do not feed to layers or water fowl; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.
(ii) Amount per ton. Halofuginone hydrobromide 1.36 to 2.72 grams plus bacitracin methylene disalicylate 10 to 50 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis., and E. gallopavonis, and for increased rate of weight gain in growing turkeys.
(B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl. Keep out of lakes, ponds, and streams. Halofuginone is toxic to fish and aquatic life. Halofuginone is an irritant to eyes and skin. Avoid contact with skin, eyes, or clothing.
(iii) Amount per ton. 1.36 to 2.72 grams of halofuginone hydrobromide plus 2 grams of bambermycins.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain in growing turkeys.
(B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl. Halofuginone hydrobromide is toxic to fish and other aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an eye and skin irritant. Avoid contact with skin, eyes, and clothing.
(3) It is used in feed for replacement cage laying chickens and replacement broiler breeder chickens as follows:
(i) Amount per ton. 2.72 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti.
(B) Limitations. Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Withdraw 4 days before slaughter. Do not feed to laying chickens or water fowl. Halofuginone hydrobromide is toxic to fish and aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an irritant to eyes and skin. Avoid contact with skin, eyes, and clothing.
(ii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus roxarsone, 22.7 to 45.4 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(B) Limitations. Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Use as the sole source of organic arsenic; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens or waterfowl. Withdraw 5 days before slaughter.
[50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006]
§ 558.274 Hygromycin B.
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(a) Approvals. (1) Type A medicated articles: 2.4 and 8 grams per pound to 000986 in §510.600(c) of this chapter for use as in paragraph (c) of this section.
(2) 2.4 grams per pound to Nos. 043733 and 051311 in §510.600(c) of this chapter for use in swine feed as in paragraph (c)(1)(ii) of this section.
(3) [Reserved]
(4) 0.6 gram per pound to 017790 and 043733 in §510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) of this section and in swine as in paragraph (c)(1)(ii) of this section.
(5)–(6) [Reserved]
(7) 2.4 grams per pound to 017519 in §510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) and in swine as in paragraph (c)(1)(ii) of this section.
(8) 0.6 and 1.6 grams per pound granted to 046573 in §510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) and in swine as in paragraph (c)(1)(ii) of this section.
(b) Related tolerances. See §556.330 of this chapter.
(c) Conditions of use. (1) It may be used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams Hygromycin B in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 8 to 12...................... .................... Chickens: control of Withdraw 3 days 000986, infestation of large before slaughter. 017519, roundworms (Ascaris 017790, galli), cecal worms 043733, (Heterakis gallinae), 046573 and capillary worms (Capillaria obsignata). Bacitracin 100...... Chickens; control of As bacitracin infestation of large methylene roundworms (Ascaris disalicylate or galli), cecal worms zinc bacitracin; (Heterakis gallinae), withdraw 3 days and capillary worms before slaughter. (Capillaria obsignata); treatment of chronic respiratory disease (airsac infection), blue comb (nonspecific infectious enteritis). Bacitracin plus 1. Chickens; control of Feed containing not penicillin (100 to infestation of large less than 25% of 200 of combination). roundworms (Ascaris penicillin plus galli), cecal worms not less than 50% (Heterakis gallinae), of bacitracin; as and capillary worms procaine (Capillaria penicillin plus obsignata); treatment bacitracin of chronic respiratory methylene disease (airsac disalicylate; infection), blue comb withdraw 3 days (nonspecific before slaughter. infectious enteritis). 2. Chickens; control of Combination infestation of large containing not roundworms (Ascaris less than 50% nor galli), cecal worms more than 75% of (Heterakis gallinae), bacitracin, except and capillary worms that it contains (Capillaria not more than 125 obsignata); treatment g of penicillin; of chronic respiratory as procaine disease (airsac penicillin plus infection), blue comb zinc bacitracin; (nonspecific withdraw 3 days infectious enteritis). before slaughter. 3. Chickens, control of Combination infestation of large containing 50% to roundworms (Ascaris 75% bacitracin, galli), cecal worms but not more than (Heterakis gallinae), 125 g of and capillary worms penicillin, as (Capillaria procaine obsignata); treatment penicillin; of chronic respiratory withdraw 3 days disease (airsac before slaughter.. infection), blue comb (nonspecific infectious enteritis). Chlortetracycline Chickens; control of Do not feed to 100 to 200. infestation of large chickens producing roundworms (Ascaris eggs for human galli), cecal worms consumption; feed (Heterakis gallinae), for 7 to 14 days; and capillary worms withdraw 3 days (Capillaria before slaughter. obsignata); control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Chlortetracycline Chickens; control of ......do........... 200 to 400. infestation of large roundworms (Ascaris galli), cecal worms (H. Gallinae), and capillary worms (Capillaria obsignata); control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. Penicillin 100...... Chickens; control of As procaine infestation of large penicillin; roundworms (Ascaris withdraw 3 days galli), cecal worms before slaughter. (Heterakis gallinae), and capillary worms (Capillaria obsignata); treatment of chronic respiratory disease (airsac infection), blue comb (nonspecific infectious enteritis). Tylosin 4 to 50..... Chickens: Control of As tylosin 000986 infestations of large phosphate; roundworms (Ascaris withdraw 3 days galli), cecal worms before slaughter. (Heterakis gallinae), and capillary worms (Capillaria obsignata); growth promotion and feed efficiency.(ii) 12.......................... .................... Swine: control of Withdraw 15 days 000986, infestation of large before slaughter. 017519, roundworms (Ascaris 017790, suis), nodular worms 043733, (Oesophagostomum 046573, dentatum), and 051311 whipworms (Trichuris suis). Chlortetracycline Swine; control of Withdraw 15 d 400.. infestation of large before slaughter.. roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis); treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline.. Tylosin 10 to 100... Swine: Control of As tylosin 000986 infestations of large phosphate; roundworms (Ascaris withdraw 15 days suis), nodular worms prior to (Oesophagostomum slaughter; feed dentatum), and continuously as whipworms (Trichuris follows:. suis); growth Animal wt.(lbs.):.. promotion and feed Up to 40........20 efficiency. to 100\1\. 41 to 100........20 to 40\1\. 101 to market wt........10 to 20\1\.----------------------------------------------------------------------------------------------------------------\1\ Amount of Tylosin (g/t).
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(2) Hygromycin B may also be used in combination with:
(i) Amprolium in accordance with §558.55.
(ii) Zoalene in accordance with §558.680.
[41 FR 11000, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.274, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.295 Iodinated casein.
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(a) Approvals. See 017762 in §510.600(c) of this chapter.
(b) NAS/NRC status. The use of this drug is NAS/NRC reviewed and found effective. Applications for these uses need not include efficacy data as required by §514.111 of this chapter but may require bioequivalency or safety data.
(c) Conditions of use—(1) Ducks—(i) Amount per ton. 100 to 200 grams.
(ii) Indications for use. For increased rate of weight gain and improved feathering in growing ducks.
(2) Dairy cows—(i) Amount per pound. 1/2 to 11/2 grams per 100 lb of body weight.
(ii) Indications for use. For increased milk production in dairy cows.
(iii) Limitations. This drug is effective for limited periods of time, and the effectiveness is limited to the declining phase of lactation. Administration must be accompanied with increased feed intake; administration may increase heat sensitivity of the animal.
[45 FR 41631, June 20, 1980]
§ 558.300 Ivermectin.
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(a) Approvals. (1) Type A medicated articles: 0.6 percent (2.72 grams per pound; 6 grams per kilogram) to 050604 in §510.600(c) of this chapter, and
(2) Type B medicated feeds for ivermectin alone or with lincomycin. See §558.4 of this chapter for maximum drug levels to 050604 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.344 of this chapter.
(c) [Reserved]
(d) Conditions of use. It is used in swine feed as follows:
(1) Amount per ton. For weaned, growing-finishing swine, feed 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day). For adult and breeding swine, feed 1.8 to 11.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day). For adult and breeding swine, may be top-dressed on daily ration for individual treatment at levels of 18.2 to 1180 grams (to provide 0.1 milligram per kilogram of body weight per day).
(i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).
(ii) Limitations. For use in swine feed only. Feed as only feed for 7 consecutive days. Withdraw 5 days before slaughter. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(2) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 20 grams of lincomycin.
(i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For increased rate of weight gain.
(ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days. Withdraw 5 days before slaughter. A separate feed containing 20 grams per ton lincomycin may be continued. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(3) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 40 grams of lincomycin.
(i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For control of swine dysentery. For use in swine on premises with a history of swine dysentery, but where symptoms have not yet occurred.
(ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days. Withdraw 5 days before slaughter. A separate feed containing 40 grams per ton lincomycin may be continued. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
(4) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 100 grams of lincomycin.
(i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). Treatment of swine dysentery.
(ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days followed by a separate feed containing 100 grams per ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(5) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 200 grams of lincomycin.
(i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For reduction in severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.
(ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days followed by a separate feed containing 200 grams per ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(6) Amount per ton. For weaned, growing-finishing pigs, feed 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day), and 10 to 30 or 250 grams of bacitracin methylene disalicylate. For adult and breeding swine, feed 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day), and 10 to 30 or 250 grams of bacitracin methylene disalicylate.
(i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). For increased rate of weight gain and improved feed efficiency in growing and finishing swine. For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. For control of swine dysentery associated with Treponema hypdysenteriae on premises with a history of swine dysentery but where signs of disease have not yet occurred, or following an approved treatment of disease condition.
(ii) Limitations. For use in swine feed only. Feed as the only feed for 7 consecutive days. For weaned growing and finishing swine, feed bacitracin methylene disalicylate Type C medicated feed from weaning to market weight for increased rate of weight gain and improved feed efficiency. For pregnant sows, feed bacitracin methylene disalicylate to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Withdraw ivermectin-containing feeds 5 days before slaughter.
[58 FR 58653, Nov. 3, 1993, as amended at 60 FR 39848, Aug. 4, 1995; 61 FR 32652, June 25, 1996; 62 FR 63271, Nov. 28, 1997; 63 FR 54353, Oct. 9, 1998; 64 FR 13342, Mar. 18, 1999]
§ 558.305 Laidlomycin.
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(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.
(b) Approvals. See No. 046573 in §510.600(c) of this chapter.
(c) Tolerances. See §556.346 of this chapter.
(d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 7 days after date of manufacture.
(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:
(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.
(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.
(iii) Not for use in animals intended for breeding.
(e) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams Laidlomycin in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(1) 5............................ .................... For improved feed Feed continuously 046573 efficiency and in a Type C feed increased rate of at a rate of 30 to weight gain.. 75 mg/head/day..(2) 5............................ Chlortetracycline10 For improved feed Feed continuously 046573 mg/lb body weight. efficiency and at a rate of 30 to increased rate of 75 mg laidlomycin weight gain; and for propionate treatment of bacterial potassium per head enteritis caused by per day for not Echerichia coli and more than 5 days. bacterial pneumonia A withdrawal caused by Pasteurella period has not multocida organisms been established susceptible to for this product chlortetracycline.. in pre-ruminating calves. Do not use in calves to be processed for veal..(3) 5............................ Chlortetracycline For improved feed Feed continuously 046573 350 mg/head/day. efficiency and at a rate of 30 to increased rate of 75 mg laidlomycin weight gain; and for propionate control of bacterial potassium per head pneumonia associated per day. A with shipping fever withdrawal period complex caused by has not been Pasteurella spp. established for susceptible to this product in chlortetracycline.. pre-ruminating calves. Do not use in calves to be processed for veal..(4) 5 to 10...................... .................... For improved feed Feed continuously 046573 efficiency.. in a Type C feed at a rate of 30 to 150 milligrams/ head/day..(5) 5 to 10...................... Chlortetracycline 10 For improved feed Feed continuously 046573 mg/pound body efficiency; and for at a rate of 30 to weight. treatment of bacterial 150 mg laidlomycin enteritis caused by E. propionate coli and bacterial potassium per head pneumonia caused by P. per day for not multocida organisms more than 5 days. susceptible to A withdrawal chlortetracycline.. period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal..(6) 5 to 10...................... Chlortetracycline For improved feed Feed continuously 046573 350 mg/head/day. efficiency; and for at a rate of 30 to control of bacterial 150 mg laidlomycin pneumonia associated propionate with shipping fever potassium per head complex caused by per day. A Pasteurella spp. withdrawal period susceptible to has not been chlortetracycline.. established for this product in pre-ruminating calves. Do not use in calves to be processed for veal..----------------------------------------------------------------------------------------------------------------
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[59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004]
§ 558.311 Lasalocid.
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(a) Specifications. A minimum of 90 percent of lasalocid activity is derived from lasalocid A.
(b) Approvals. Type A medicated articles approved for sponsors identified in §510.600(c) of this chapter for use as in paragraph (e) of this section as follows:
(1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, 5.7, 6.0, 6.3, 6.7, 7.2, 7.5, 8.0, 8.3, 10.0, 12.5, 15, 20, and 50 percent activity to No. 046573 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) of this section.
(2) 15 percent activity to No. 066104 as provided by No. 046573 for use as in paragraph (e)(1)(v) of this section.
(3) 15, 20, 33.1, and 50 percent activity to No. 046573 for use in cattle feeds as in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and (xv) of this section, and for use in sheep as in paragraph (e)(1)(viii) of this section.
(4) 15 percent activity to No. 046573 for use in Type C rabbit feeds as in paragraph (e)(1)(xvi) of this section and for use in ruminant free-choice Type C feeds as in paragraphs (e)(2), (e)(3), and (e)(4) of this section.
(5) 15 percent activity to 021930 (Type A article provided by 046573) for use in free-choice vitamin-mineral Type C cattle feeds as in paragraph (e)(1)(xi).
(6) 20 percent activity as a liquid Type A article to No. 046573 for use in cattle feeds as in paragraphs (e)(1)(vi), (e)(1)(vii), (e)(1)(ix), (e)(1)(xi), (e)(1)(xii), and (e)(3) of this section, and for use in sheep feeds as in paragraph (e)(1)(viii) of this section.
(7) 20 percent activity to No. 046573 for use as follows:
(i) Chukar partridges as in paragraph (e)(1)(xiii).
(ii) Turkeys as in paragraph (e)(1)(xiv).
(iii) Rabbits as in paragraph (e)(1)(xvi).
(8) 15 percent activity to No. 017800 for use as in paragraph (e)(1)(xviii) of this section.
(9) 15 percent activity to No. 068287 for use in free-choice protein blocks for cattle as in paragraphs (e)(1)(xix) of this section.
(c) Related tolerance. See §556.347 of this chapter.
(d) Special considerations. (1) Type C cattle and sheep feeds may be manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.
(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by:
(i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product;
(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and
(iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure.
(4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived.
(5) Required label statements:
(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.
(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an approved NADA or supplemental NADA as provided in §510.455 of this chapter.
(e)(1) Conditions of use. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Lasalocid sodium activity in Combination in grams grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 68 (0.0075 pct) to 113 .................... For the prevention of For broiler or 046573 (0.0125 pct). coccidiosis caused by fryer chickens Eimeria tenella, E. only; feed necatrix, E. continuously as acervulina, E. the sole ration. brunetti, E. mivati, and E. maxima.(ii) 68 (0.0075 pct) to 113 Roxarsone 45.4 Broiler or fryer For broiler or 046573 (0.0125 pct). (0.005 pct). chickens; for the fryer chickens prevention of only; feed coccidiosis caused by continuously as Eimeria tenella, E. the sole ration; necatrix, E. as sole source of acervulina, E. organic arsenic; brunetti, E. mivati, withdraw 5 d and E. maxima and as before slaughter; an aid in the roxarsone provided reduction of lesions by Nos. 046573 and due to E. tenella. 011526 in § 510.600(c) of this chapter. Roxarsone 45.4 plus For prevention of For broiler 046573 bambermycins 1 coccidiosis caused by chickens only; (0.00011 pct). Eimeria tenella, E. feed continuously necatrix, E. as sole ration; acervulina, E. withdraw 5 days brunetti, E. mivati, before slaughter; and E. maxima; as an roxarsone provided aid in the reduction by Nos. 046573 and of lesions due to E. 011526 in § tenella; and for 510.600(c) of this increased rate of chapter, weight gain. bambermycins provided by No. 016592. Bambermycins 1 to 2. Broiler chickens: For Feed continuously 016592 prevention of as sole ration. coccidiosis caused by Bambermycins Eimeria tenella, E. provided by No. necatrix, E. 016592 in § acervulina, E. 510.600(c) of this brunetti, E. mivati, chapter.. and E. maxima; and for increased rate of weight gain and improved feed efficiency.. Roxarsone 45.4 plus For prevention of For broiler 046573 lincomycin 2.0. coccidiosis caused by chickens only; Eimeria tenella, E. feed continuously necatrix, E. as sole ration; acervulina, E. withdraw 5 days brunetti, E. mivati, before slaughter; and E. maxima; as an roxarsone provided aid in the reduction by Nos. 046573 and of lesions due to E. 011526 in § tenella; and for 510.600(c) of this increased rate of chapter, weight gain and lincomycin improved feed provided by No. efficiency. 000009. Roxarsone 45.4 plus For prevention of For broiler or 046573 bacitracin 10 to 25. coccidiosis caused by fryer chickens Eimeria tenella, E. only; feed necatrix, E. continuously as acervulina, E. the sole ration; brunetti, E. mivati, withdraw 5 days and E. maxima; as an before slaughter; aid in the reduction roxarsone provided of lesions due to E. by Nos. 046573 and tenella; and for 011526 in § increased rate of 510.600(c) of this weight gain. chapter, bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter. Roxarsone 45.4 plus For prevention of For broiler 046573 bacitracin 10 or 30. coccidiosis caused by chickens only; E. tenella, E. feed continuously necatrix, E. as sole ration; acervulina, E. withdraw 5 days brunetti, E. mivati before slaughter; and E. maxima; as an roxarsone provided aid in the reduction by Nos. 046573 and of lesions due to E. 011526 in § tenella; and for 510.600(c) of this increased rate of chapter, weight gain (10 grams bacitracin zinc per ton) or improved provided by No. feed efficiency (30 000004. grams per ton). Roxarsone 45.5 plus Prevention of Feed continuously 046573 bacitracin coccidiosis caused by as sole ration; as methylene Eimeria necatrix, E. sole source of disalicylate 50. tenella, E. organic arsenic; acervulina, E. withdraw 5 days brunetti; E. mivati, before slaughter. and E. maxima; reduction of lesions due to E. tenella; prevention of necrotic enteritis caused or complicated by Clostridium spp. or other susceptible organisms.(iii) 68 (0.0075 pct)............ Lincomycin 2 Broiler or fryer For broiler and 046573 (0.00022 pct). chickens; for the fryer chickens prevention of only; feed coccidiosis caused by continuously as Eimeria mivati, E. sole ration; brunetti, E. tenella, withdraw 5 d E. acervulina, E. before slaughter; maxima, and E. Type C feed must necatrix; for be used within 4 increased rate of weeks of weight gain and manufacture; as improved feed lincomycin efficiency. hydrochloride monohydrate.(iv) 68 (0.0075 percent)......... Bacitracin 10 to 50. For prevention of For broiler or 046573 coccidiosis caused by fryer chickens Eimeria tenella, E. only; feed necatrix, E. continuously as acervulina, E. the sole ration; brunetti, E. mivati, bacitracin and E. maxima, and for methylene increased rate of disalicylate weight gain and provided by No. improved feed 046573 in § efficiency. 510.600(c) of this chapter.(v) 68 (0.0075 pct) to 113 Virginiamycin 20.... For prevention of For broiler and 046573 (0.0125 pct). coccidiosis caused by fryer chickens Eimeria tenella E. only; feed necatrix, E. continuously as acervulina, E. sole ration; do brunetti, E. mivati, not feed to laying and E. maxima, and for chickens; increased rate of lasalocid sodium weight gain and provided by No. improved feed 046573 in § efficiency. 510.600(c) of this chapter.(vi) 10 (0.0011 pct) to 30 .................... Cattle; for improved In Type C feeds; 046573 (0.0033 pct). feed efficiency. for cattle fed in confinement for slaughter only; feed continuously in complete feed to provide not less than 100 mg nor more than 360 mg of lasalocid sodium activity per head per day. Oxytetracycline 7.5. Cattle: for improved In Type C feeds, 046573 feed efficiency and for beef cattle reduction of incidence fed in confinement and severity of liver for slaughter; abscesses. feed continuously at 100 to 360 mg/ head/day lasalocid and 75 mg/head/day oxytetracycline. As monoalkyl (C8- C18) trimethyl ammonium oxytetracycline.(vii) 25 (0.0027 pct) to 30 .................... Cattle; for improved In Type C feeds; 046573 (0.0033 pct). feed efficiency and for cattle fed in increased rate of confinement for weight gain. slaughter only; feed continuously in complete feed to provide not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day. Oxytetracycline 7.5. Cattle: for improved In Type C feeds, 046573 feed efficiency, for beef cattle increased rate of fed in confinement weight gain, and for slaughter; reduction of incidence feed continuously and severity of liver at 250 to 360 mg/ abscesses. head/day lasalocid and 75 mg/head/day oxytetracycline. As monoalkyl (C8- C18) trimethyl ammonium oxytetracycline.(viii) 20 (0.0022 pct) to 30 .................... Sheep; for the In Type C feeds; 046573 (0.0033 pct). prevention of for sheep coccidiosis caused by maintained in Eimeria ovina, E. confinement; feed crandallis, E. continuously in ovinoidalis (E. complete feed to ninakohlyakimovae), E. provide not less parva, and E. than 15 mg nor intricata. more than 70 mg of lasalocid sodium activity per head per day depending on body weight.(ix)............................. .................... Pasture cattle Feed continuously 046573 (slaughter, stocker, at a rate of not feeder cattle, and less than 60 mg or dairy and beef more than 300 mg replacement heifers): of lasalocid per for increased rate of head per day when weight gain. Intakes on pasture; the of lasalocid in excess drug must be of 200 mg/head/day contained in at have not been shown to least 1 pound of be more effective than feed.. 200 mg/head/day..(x) 68 (0.0075 pct) to 113 Bacitracin 4 to 50.. Broiler chickens; for For broiler 046573 (0.0125 pct). prevention of chickens only; coccidiosis caused by feed continuously Eimeria tenella, E. as the sole necatrix, E. ration; bacitracin acervulina, E. methylene brunetti, E. mivati, disalicylate and E. maxima; and for provided by No. improved feed 046573 in § efficiency. 510.600(c) of this chapter.(xi) 68 (0.0075 pct) to 113 Bacitracin zinc 4 to Broiler chickens. For Feed continuously 046573 (0.0125 pct). 50. prevention of as sole ration. coccidiosis caused by Bacitracin zinc Eimeria tenella, E. and lasalocid necatrix, E. sodium as provided acervulina, E. by No. 046573 in brunetti, E. mivati, § 510.600(c) and E. maxima, and for of this chapter.. increased rate of weight gain and improved feed efficiency..(xii)............................ .................... Pasture cattle Feed continuously 046573 (slaughter, stocker, on a free-choice feeder cattle, and basis at a rate of dairy and beef not less than 60 replacement heifers): mg or more than For increased rate of 300 mg of weight gain. Intakes lasalocid per head of lasalocid in excess per day.. of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day..(xiii)........................... .................... Cattle; for control of For cattle; hand 046573 coccidiosis caused by feed at a rate of Eimeria bovis and 1 mg of lasalocid Eimeria zuernii. per 2.2 pounds body weight per day to cattle weighing up to 800 pounds with a maximum of 360 mg of lasalocid per head per day.(xiv) 113 (0.0125 pct)........... .................... Chukar partridges; for Feed continuously 046573 prevention of as sole ration up coccidiosis caused by to 8 weeks of age. Eimeria legionensis.(xv) 68 (0.0075 pct) to 113 .................... Growing turkeys; for Feed continuously 046573 (0.0125 pct). prevention of as sole ration. coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides.. Bacitracin 4 to 50.. Growing turkeys; for Feed continuously 046573 prevention of as sole ration. coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; for increased rate of weight gain and improved feed efficiency.. Bacitracin methylene Growing turkeys; for Feed continuously 046573 disalicylate 4 to prevention of as sole ration. 50. coccidiosis caused by Bacitracin E. meleagrimitis, E. methylene gallopavonis, and E. disalicylate as adenoeides; for provided by No. increased rate of 046573 in § weight gain and 510.600(c) of this improved feed chapter.. efficiency.. Virginiamycin 10 to Growing turkeys; for Feed continuously 046573 20. prevention of as sole ration. As coccidiosis caused by lasalocid sodium E. meleagrimitis, E. provided by 063238 gallopavonis, and E. and virginiamycin adenoeides, and for provided by increased rate of 066104.. weight gain and improved feed efficiency..(xvi)............................ .................... Replacement calves; for In milk replacer 046573 control of coccidiosis powder; hand feed caused by E. bovis and at a rate of 1 mg E. zuernii.. of lasalocid per 2.2 lb body weight per day; include on labeling warning: ``A withdrawal period has not been established for lasalocid in pre- ruminating calves. Do not use in calves to be processed for veal''.(xvii) 113 (0.0125 pct).......... .................... Rabbits; for prevention Feed continuously 046573 of coccidiosis caused as sole ration up by Eimeria stiedae. to 6 1/2 weeks of age.(xviii) 1440..................... .................... Pasture cattle Feed continuously 021930 (slaughter, stocker, on a free-choice 017800 feeder cattle, and basis at a rate of dairy and beef not less than 60 replacement heifers): mg nor more than For increased rate of 200 mg of weight gain.. lasalocid per head per day..(xix) 300........................ .................... Pasture cattle Feed continuously 068287 (slaughter, stocker, on a free-choice feeder cattle, and basis at a rate of dairy and beef not less than 60 replacement heifers): mg nor more than for increased rate of 200 mg of weight gain.. lasalocid per head per day..(xx) 10 to 30.................... Chlortetracycline 25 1. Cattle fed in Feed continuously 046573 to 100. confinement for in complete feed slaughter: For at a rate of 350 improved feed mg efficiency; and for chlortetracycline control of bacterial and not less than pneumonia associated 100 mg nor more with shipping fever than 360 mg of complex caused by lasalocid sodium Pasteurella spp. activity per head susceptible to per day.. chlortetracycline.. .................... 2. Cattle under 700 Feed continuously 046573 pounds fed in in complete feed confinement for at a rate of 350 slaughter: For mg improved feed chlortetracycline efficiency; and for and not less than control of active 100 mg nor more infection of than 360 mg of anaplasmosis caused by lasalocid sodium Anaplasma marginale activity per head susceptible to per day.. chlortetracycline..(xxi) 10 to 30................... Chlortetracycline Cattle fed in Feed continuously 046573 500 to 2000. confinement for in complete feed slaughter: For for not more than improved feed 5 days to provide efficiency; and for 10 mg treatment of bacterial chlortetracycline enteritis caused by E. per lb body weight coli and bacterial per day and not pneumonia caused by P. less than 100 mg multocida organisms nor more than 360 susceptible to mg of lasalocid chlortetracycline.. sodium activity per head per day..(xxii) 25 to 30.................. Chlortetracycline 25 1. Cattle fed in Feed continuously 046573 to 42.2. confinement for in complete feed slaughter: For at a rate of 350 increased rate of mg weight gain and chlortetracycline improved feed and not less than efficiency; and for 250 mg nor more control of bacterial than 360 mg of pneumonia associated lasalocid sodium with shipping fever activity per head complex caused by per day.. Pasteurella spp. susceptible to chlortetracycline.. .................... 2. Cattle under 700 Feed continuously 046573 pounds fed in in complete feed confinement for at a rate of 350 slaughter: For mg increased rate of chlortetracycline weight gain and and not less than improved feed 250 mg nor more efficiency; and for than 360 mg of control of active lasalocid sodium infection of activity per head anaplasmosis caused by per day.. Anaplasma marginale susceptible to chlortetracycline..(xxiii) 25 to 30................. Chlortetracycline Cattle fed in Feed continuously 046573 500 to 1200. confinement for in complete feed slaughter: For for not more than increased rate of 5 days to provide weight gain and 10 mg improved feed chlortetracycline efficiency; and for per lb body weight treatment of bacterial per day and not enteritis caused by E. less than 250 mg coli and bacterial nor more than 360 pneumonia caused by P. mg of lasalocid multocida organisms sodium activity susceptible to per head per day.. chlortetracycline..(xxiv) 30 to 181.8............... Chlortetracycline 25 1. Beef cattle under Hand feed 046573 to 2800. 700 pounds: For continuously at a control of coccidiosis rate of 350 mg caused by Eimeria chlortetracycline bovis and E. zuernii; per head per day and for control of and 1 mg lasalocid active infection of per 2.2 lb body anaplasmosis caused by weight per day Anaplasma marginale with a maximum of susceptible to 360 mg lasalocid chlortetracycline.. per head per day.. .................... 2. Beef cattle up to Hand feed 046573 800 pounds: For continuously at a control of coccidiosis rate of 350 mg caused by Eimeria chlortetracycline bovis and E. zuernii; per head per day and for control of and 1 mg lasalocid bacterial pneumonia per 2.2 lb body associated with weight per day shipping fever complex with a maximum of caused by Pasteurella 360 mg lasalocid spp. susceptible to per head per day.. chlortetracycline..(xxv) 30 to 181.8................ Chlortetracycline Cattle up to 800 Hand feed 046573 500 to 4000. pounds: For control of continuously for coccidiosis caused by not more than 5 Eimeria bovis and E. days to provide 10 zuernii; and for mg treatment of bacterial chlortetracycline enteritis caused by E. per lb body weight coli and bacterial per day and 1 mg pneumonia caused by P. lasalocid per 2.2 multocida organisms lb body weight per susceptible to day with a maximum chlortetracycline.. of 360 mg lasalocid per head per day..(xxvi) 30 to 600................. Chlortetracycline 25 1. Pasture cattle Hand feed 046573 to 700. (slaughter, stocker, continuously at a feeder cattle, and rate of 350 mg beef replacement chlortetracycline heifers): for and not less than increased rate of 60 mg or more than weight gain; and for 300 mg lasalocid control of bacterial per head daily in pneumonia associated at least 1 lb of with shipping fever feed. Intakes of complex caused by lasalocid in Pasteurella spp. excess of 200 mg/ susceptible to head/day have not chlortetracycline.. been shown to be more effective than 200 mg/head/ day.. .................... 2. Pasture cattle under Hand feed 046573 700 pounds (slaughter, continuously at a stocker, feeder rate of 350 mg cattle, and beef chlortetracycline replacement heifers): and not less than for increased rate of 60 mg or more than weight gain; and for 300 mg lasalocid control of active per head daily in infection of at least 1 lb of anaplasmosis caused by feed. Intakes of Anaplasma marginale lasalocid in susceptible to excess of 200 mg/ chlortetracycline.. head/day have not been shown to be more effective than 200 mg/head/ day..(xxvii) 30 to 600................ Chlortetracycline 25 Pasture cattle over 700 Hand feed 046573 to 1100. pounds (slaughter, continuously at a stocker, feeder rate of 0.5 mg cattle, and beef chlortetracycline replacement heifers): per lb body weight For increased rate of per day and not weight gain; and for less than 60 mg or control of control of more than 300 mg active infection of lasalocid per head anaplasmosis caused by daily in at least Anaplasma marginale 1 lb of feed. susceptible to Intakes of chlortetracycline.. lasalocid in excess of 200 mg/ head/day have not been shown to be more effective than 200 mg/head/ day..(xxviii) 30 to 600............... Chlortetracycline Pasture cattle Hand feed 046573 500 to 4000.. (slaughter, stocker, continuously for feeder cattle, and not more than 5 dairy and beef days to provide 10 replacement heifers): mg For increased rate of chlortetracycline weight gain; and for per lb body weight treatment of bacterial per day and not enteritis caused by E. less than 60 mg or coli and bacterial more than 300 mg pneumonia caused by P. lasalocid per head multocida organisms daily in at least susceptible to 1 lb of feed. chlortetracycline.. Intakes of lasalocid in excess of 200 mg/ head/day have not been shown to be more effective than 200 mg/head/ day..----------------------------------------------------------------------------------------------------------------
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(2) It is used as a free-choice mineral Type C feed as follows:
(i) Specifications.
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------------------------------------------------------------------------ Ingredient Percent International feed No.------------------------------------------------------------------------Defluorinated Phosphate (20.5 35.9 6-01-080 percent Calcium, 18.5 percent Phosphorus).Sodium Chloride (Salt)............ 20.0 6-04-152Calcium Carbonate (38 percent 18.0 6-01-069 Calcium).Cottonseed Meal................... 10.0 5-01-621Potassium Chloride................ 3.0 6-03-755Selenium Premix (0.02 percent 3.0 .......................... Selenium) \1\.Dried Cane Molasses............... 2.5 4-04-695Magnesium Sulfate................. 1.7 6-02-758Vitamin Premix \1\................ 1.4 ..........................Magnesium Oxide................... 1.2 6-02-756Potassium Sulfate................. 1.2 6-06-098Trace Mineral Premix \1\.......... 1.04 ..........................Bovatec Premix (68 grams per 1.06 .......................... pound).------------------------------------------------------------------------\1\ Content of this vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with § 573.920 of this chapter. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).
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(ii) Amount. 1,440 grams per ton (0.16 percent).
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.
(v) Sponsor. See No. 046573 in §510.600(c) of this chapter.
(3) It is used as a ruminant free-choice liquid Type C feed as follows:
(i) Specifications.
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------------------------------------------------------------------------ Ingredient Percent International feed No.------------------------------------------------------------------------Cane Molasses.................... 55.167 4-13-241Condensed Molasses Fermentation 24.0 N/A Solubles.50% Urea Solution (23% N)........ 12.0 N/AAmmonium Polyphosphate Solution.. 1.0 6-08-42Phosphoric Acid (54%)............ 3.0 6-03-707Xanthan Gum...................... 0.05 8-15-818Water............................ 4.0 N/ATrace Mineral Mix \1\............ 0.5 N/AVitamin Premix \1\............... 0.2 N/ABovatec Liquid 20 (90.8 gm/lb) 0.083 N/A \2\.------------------------------------------------------------------------\1\ Content of vitamin and trace mineral premixes may be varied; however, they should be comparable to those used for other free-choice liquid feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with § 573.920 of this chapter. EDDI should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).\2\ To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of Bovatec Liquid 20 (90.8 gm/lb). If dry Bovatec-68 (68 gm/lb) is used, use 2.206 lbs per ton (0.111%), replacing molasses.
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(ii) Amount. 150 grams per ton (.017 percent).
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.
(v) Sponsor. See No. 046573 in §510.600(c) of this chapter.
(4) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications.
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------------------------------------------------------------------------ Ingredient Percent International feed No.------------------------------------------------------------------------Monocalcium Phosphate (21% P)..... 57.70 6-01-082Salt.............................. 17.55 6-04-152Distillers Dried Grains w/Solubles 5.40 5-28-236Dried Cane Molasses (46% Sugars).. 5.20 4-04-695Potassium Chloride................ 4.90 6-03-755Trace Mineral/Vitamin Premix\1\... 3.35 ..........................Calcium Carbonate (38% Ca)........ 2.95 6-01-069Mineral Oil....................... 1.05 8-03-123Magnesium Oxide (58% Mg).......... 1.00 6-02-756Iron Oxide (52% Fe)............... 0.10 6-02-431Lasalocid Type A Medicated Article 0.80 .......................... (68 g per pound).------------------------------------------------------------------------\1\ Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice loose mineral feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with § 573.920 of this chapter. EDDI should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
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(ii) Amount. 1,088 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.
(v) Sponsor. See No. 046573 in §510.600(c) of this chapter.
(5) Additional combinations. Lasalocid may be used in accordance with the provisions of this section in combination as follows:
(i) Melengestrol acetate alone or in combination with tylosin in accordance with §558.342.
(ii) [Reserved]
[41 FR 44382, Oct. 8, 1976]
Editorial Note: For Federal Register citations affecting §558.311, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.315 Levamisole hydrochloride (equivalent).
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(a) Approvals. Type A medicated articles: 227 grams per pound to No. 053501 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.350 of this chapter.
(c) Conditions of use. It is used in Type C medicated feed as follows:
(1) Cattle—(i) Amount per pound. 0.36–3.6 grams (0.08–0.8 percent).
(ii) Indications for use. Treatment of the following gastrointestinal worms and lung worm infections; stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus).
(iii) Limitations. Administer medicated feed mixed thoroughly in one half the usual amount of morning feed; the medicated feed mix should be consumed within 6 hours; when medicated feed is consumed resume normal feeding; medicated feed is to be fed at the rate of 0.36 gram of levamisole hydrochloride (equivalent) per 100 lb. of body weight; conditions of constant helminth exposure may require retreatment within 2 to 4 weeks after the first treatment; do not slaughter for food within 48 hours of treatment; consult veterinarian before using in severely debilitated animals; do not administer to dairy animals of breeding age; for use in pelleted or meal feeds only; the label shall bear the caution, “Muzzle foam may be observed. However, this reaction will disappear within a few hours. If this condition persists, a veterinarian should be consulted. Follow recommended dosage carefully.”
(2) Swine—(i) Amount per pound. 0.36 grams (0.08 percent).
(ii) Indications for use. Treatment of the following nematode infections: large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), swine kidney worms $(Stephanurus dentatus).
(iii) Limitations. It is recommended that regular feed be withheld overnight and worming feed administered the following morning; dilute supplement with nonmedicated feed as directed; feed the equivalent of 1 lb. of 0.08 percent worming feed per 100 lbs. of body weight of pigs to be treated; may be fed as sole feed or thoroughly mixed with 1 to 2 parts of regular feed prior to feeding; when medicated feed is consumed, resume normal feeding. Pigs maintained under conditions of constant worm exposure may require retreatment within 4 to 5 weeks after the first treatment due to reinfection; do not slaughter for food within 72 hours of treatment; the label shall bear the caution, “Excessive salivation or muzzle foam may be observed. This reaction is occasionally seen and will disappear in a short time after medication. If pigs are infected with mature lungworms, coughing and vomiting may be observed soon after medicated feed is consumed. This reaction is due to the expulsion of worms from the lungs and will be over in several hours.”
[40 FR 13959, Mar. 27, 1975, as amended at 43 FR 11176, Mar. 17, 1978; 43 FR 39351, Sept. 5, 1978; 43 FR 16013, Mar. 16, 1979; 51 FR 7398, Mar. 3, 1986; 67 FR 63055, Oct. 10, 2002]
§ 558.325 Lincomycin.
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(a) Approvals. Type A articles and Type B feeds approved for sponsors in §510.600(c) of this chapter for specific uses as in paragraph (d) of this section as follows:
(1) No. 000009 for 20 and 50 grams per pound.
(2)–(4) [Reserved]
(5) No. 043733 for 8 and 20 grams per pound.
(6)–(12) [Reserved]
(13) No. 051311 for 2.5 and 8 grams per pound.
(14)–(15) [Reserved]
(b) Related tolerances. See §556.360 of this chapter.
(c) [Reserved]
(d) Conditions of use—(1) Chickens. It is used in feed as follows:
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---------------------------------------------------------------------------------------------------------------- Lincomycin grams/ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 2.................................... Broilers: For control of As lincomycin hydrochloride 000009 necrotic enteritis caused monohydrate.. by Clostridium spp. or other susceptible organisms..(ii) 2 to 4.............................. Broilers: For increased rate As lincomycin hydrochloride 000009 of weight gain and improved monohydrate.. feed efficiency..----------------------------------------------------------------------------------------------------------------
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(2) Swine. It is used in feed as follows:
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---------------------------------------------------------------------------------------------------------------- Lincomycin grams/ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 20................................... Growing-finishing swine: For Feed as sole ration. Not to 000009 increased rate of weight be fed to swine that weigh gain.. more than 250 pounds (lb)..(ii) 40.................................. 1. For control of swine Feed as sole ration; for use 000009 dysentery.. in swine on premises with a 043733 history of swine dysentery 051311 but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for treatment of swine dysentery. Not to be fed to swine that weigh more than 250 lb.. 2. For control of porcine Feed as sole ration, or 000009 proliferative enteropathies following use of lincomycin (ileitis) caused by at 100 g/ton for control of Lawsonia intracellularis.. porcine proliferative enteropathies (ileitis). Not to be fed to swine that weigh more than 250 lb..(iii) 100................................ 1. For treatment of swine Feed as sole ration for 3 000009 dysentery.. weeks or until signs of 043733 disease disappear. Not to 051311 be fed to swine that weigh more than 250 lb.. 2. For control of porcine Feed as sole ration for 3 000009 proliferative enteropathies weeks or until signs of (ileitis) caused by disease disappear. Not to Lawsonia intracellularis.. be fed to swine that weigh more than 250 lb..(iv) 200................................. For reduction in the Feed as sole ration for 3 000009 severity of swine weeks. Not to be fed to 051311 mycoplasmal pneumonia swine that weigh more than caused by Mycoplasma 250 lb.. hyopneumoniae..----------------------------------------------------------------------------------------------------------------
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(3) Lincomycin may also be used in combination with:
(i) Amprolium and ethopabate or amprolium and ethopabate with roxarsone in accordance with §558.58.
(ii) Clopidol in accordance with §558.175.
(iii) Decoquinate in accordance with §558.195.
(iv) Fenbendazole as provided in §558.258.
(v) Halofuginone in accordance with §558.265.
(vi) Ivermectin as in §558.300.
(vii) Lasalocid alone or with roxarsone in accordance with §558.311.
(viii) Monensin alone or with roxarsone in accordance with §558.355.
(ix) Nicarbazin alone or with narasin or roxarsone as in §558.366.
(x) Pyrantel as in §558.485.
(xi) Robenidine in accordance with §558.515.
(xii) Roxarsone in accordance with §558.530.
(xiii) Salinomycin with or without roxarsone as in §558.550.
(xiv) Zoalene in accordance with §558.680.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.325, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.340 Maduramicin ammonium.
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(a) Approvals. Type A medicated articles: 4.54 grams per pound to 046573 in §510.600(c) of this chapter.
(b) Tolerances. See §556.375 of this chapter.
(c) Conditions of use—(1) Amount. 4.54 to 5.45 grams per ton (5 to 6 parts per million) (1 to 1.2 pounds per ton).
(i) Indications for use. For prevention of coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and E. mivati.
(ii) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.
(2) [Reserved]
[54 FR 5229, Feb. 2, 1989, as amended at 54 FR 26732, June 26, 1989; 54 FR 32635, Aug. 9, 1989; 54 FR 33885, Aug. 17, 1989; 55 FR 23, Jan. 2, 1990; 55 FR 8460, Mar. 8, 1990; 55 FR 49616, Nov. 30, 1990; 59 FR 8134, Feb. 18, 1994; 61 FR 18082, Apr. 24, 1996; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001]
§ 558.342 Melengestrol.
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(a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound.
(2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound.
(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) No. 000009 for use of products described in paragraph (a) of this section.
(2) No. 021641 for use of product described in paragraph (a)(2) of this section.
(c) Related tolerances. See §556.380 of this chapter.
(d) Special considerations. (1) Type B or C medicated feeds may be manufactured from melengestrol acetate liquid Type A articles or Type B or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraphs (c)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.
(3) Combination Type B or C medicated feeds containing lasalocid must be labeled in accordance with §558.311(d)(5) of this chapter.
(4) Liquid combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be manufactured in accordance with §558.311(d) of this chapter.
(5) Combination Type B or C medicated feeds containing monensin must be labeled in accordance with §558.355(d) of this chapter.
(6) Liquid combination Type B or C medicated feeds containing melengestrol acetate and monensin must be manufactured in accordance with §558.355(f)(3)(i) of this chapter.
(7) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with §558.625(c) of this chapter.
(8) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement.
(e) Conditions of use—(1) Cattle.
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---------------------------------------------------------------------------------------------------------------- Melengestrol acetate in mg/head/ Combination in mg/ day head/day Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.25 to 0.5.................. .................... Heifers fed in Administer 0.5 to 000009, confinement for 2.0 pounds (lb)/ 021641 slaughter: For head/day of increased rate of medicated feed weight gain, improved containing 0.125 feed efficiency, and to 1.0 mg suppression of estrus melengestrol (heat).. acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/day..(ii) 0.5......................... .................... Heifers intended for Administer 0.5 to 000009, breeding: For 2.0 lb/head/day of 021641 suppression of estrus Type C feed (heat).. containing 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not exceed 24 days of feeding..(iii) 0.25 to 0.5................ Lasalocid 100 to 360 Heifers fed in Add at the rate of 000009 confinement for 0.5 to 2.0 lb/head/ slaughter: As in day a medicated paragraph (e)(1)(i) of feed (liquid or this section.. dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 grams (g) of lasalocid per ton; or add at the rate of 0.5 to 2.0 lb/ head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/ lb to a ration of nonmedicated feed to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 mg lasalocid/ head/day.. Lasalocid provided by No. 046573 in § 510.600(c) of this chapter..(iv) 0.25 to 0.5................. Lasalocid 100 to 360 Heifers fed in To administer 0.25 000009, plus tylosin 90. confinement for to 0.5 mg 021641 slaughter: As in melengestrol paragraph (e)(1)(i) of acetate plus 100 this section; and for to 360 mg reduced incidence of lasalocid plus 90 liver abscesses.. mg tylosin/head/ day:. 1. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 10 to 30 g lasalocid and 8 to 10 g tylosin per ton; or. 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/ lb to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or. 3. Add 0.5 to 2.0 lb/head/day of a dry pelleted medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 50 to 720 mg lasalocid, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed.. Lasalocid provided by No. 046573 and tylosin as tylosin phosphate by No. 000986 in § 510.600(c) of this chapter..(v) 0.25 to 0.4.................. Monensin 50 to 360.. Heifers fed in ................... 000009, confinement for Add at the rate of 021641 slaughter: As in 0.5 to 2.0 lb/head/ paragraph (e)(1)(i) of day a medicated this section.. feed (liquid or dry) containing 0.125 to 0.80 mg melengestrol acetate/lb to a feed containing 5 to 30 g monensin per ton; or add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 0.80 mg melengestrol acetate plus 25 to 720 mg monensin/lb to a nonmedicated feed to provide 0.25 to 0.40 mg melengestrol acetate and 50 to 360 mg monensin/ head/day.. Monensin provided by No. 000986 in § 510.600(c) of this chapter.. (vi) 0.25 to 0.4................ Monensin 50 to 360.. Heifers fed in ................... 000009, confinement for Add at the rate of 021641 slaughter: As in item 0.5 to 2.0 lb/head/ paragraph (e)(1)(i) of day a medicated this section; and for feed (liquid or the prevention and dry) containing control of coccidiosis 0.125 to 0.80 mg due to Eimeria bovis melengestrol and E. zuernii.. acetate/lb to a feed containing 10 to 30 g monensin per ton; or add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 0.80 mg melengestrol acetate plus 25 to 720 mg monensin/lb to a nonmedicated feed to provide 0.25 to 0.40 mg melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight, up to 360 mg monensin/head/ day.. Monensin provided by No. 000986 in § 510.600(c) of this chapter..(vii) 0.25 to 0.5................ Monensin 50 to 360 Heifers fed in To administer 0.25 000009, plus tylosin 60 to confinement for to 0.50 mg 021641 90. slaughter: As in melengestrol paragraph (e)(1)(i) of acetate to 50 to this section; for the 360 mg monensin prevention and control plus 60 to 90 mg of coccidiosis due to tylosin/head/day:. E. bovis and E. 1. Add 0.5 to 2.0 zuernii; and for lb/head/day of a reduced incidence of liquid or dry liver abscesses caused medicated feed by Fusobacterium containing 0.125 necrophorum and to 1.0 mg Actinomyces melengestrol (Corynebacterium) acetate/lb to a pyogenes.. medicated feed containing 5 to 30 g monensin and 8 to 10 g tylosin per ton; or. 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 25 to 720 mg monensin per pound to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or. 3. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate, 25 to 600 mg monensin, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed.. Monensin and tylosin as tylosin phosphate provided by No. 000986 in § 510.600(c) of this chapter..(viii) 0.25 to 0.5............... Oxytetracycline 75.. Heifers fed in Add at the rate of 000009 confinement for 0.5 to 2.0 lb/head/ slaughter: As in day a medicated paragraph (e)(1)(i) of feed (liquid or this section; and for dry) containing reduction of liver 0.125 to 1.0 mg condemnation due to melengestrol liver abscesses.. acetate/lb per pound to a feed containing 6 to 10 g oxytetracycline per ton; or add at the rate of 0.5 to 2.0 lb/head/day a dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 37.5 to 150 mg oxytetracycline/lb to provide 0.25 to 0.5 mg melengestrol acetate and 75 mg oxytetracycline/ head/day.. Oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter..(ix) 0.25 to 0.5................. Tylosin 60 to 90.... Heifers fed in To administer 0.25 000009, confinement for to 0.5 mg 021641 slaughter: As in melengestrol paragraph (e)(1)(i) of acetate with 60 to this section; and for 90 mg tylosin/head/ reduced incidence of day:. liver abscesses caused 1. Add 0.5 to 2.0 by F. necrophorum and lb/head/day of a Actinomyces liquid or dry (Corynebacterium) medicated feed pyogenes.. containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 8 to 10 g tylosin per ton; or. 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to 4.5 to 18 pounds of a dry medicated feed containing 10 to 40 g tylosin per ton; or. 3. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article) plus 45 to 180 mg tylosin/ lb to a ration of nonmedicated feed.. Tylosin as tylosin phosphate provided by No. 000986 in § 510.600(c) of this chapter..----------------------------------------------------------------------------------------------------------------
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(2) Melengestrol may also be used with ractopamine alone or in combination as in §558.500 of this chapter.
[42 FR 28535, June 3, 1977]
Editorial Note: For Federal Register citations effecting §558.342, see the List of CFR Section Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.348 Mibolerone.
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(a) Approvals. To No. 000009 in §510.600(c) of this chapter for a canned dog food, each 61/2 ounce can containing 30 or 60 micrograms of mibolerone.
(b) Conditions of use—(1) Amount. 30 micrograms for animals weighing up to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds.
(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.
(3) Limitations. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[47 FR 6617, Feb. 16, 1982]
§ 558.355 Monensin.
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(a) Specifications. Monensin, as the base or the sodium salt, contains a minimum of 90 percent monensin activity derived from monensin A and a minimum of 95 percent derived from monensin A plus B. Using thin layer chromatography, the Rf value must be comparable to a reference standard (the Rf value is the distance the spots travel from the starting line divided by the distance the solvent front travels from the starting line), or, using High Performance Liquid Chromatography, the factor distribution of monensin Factor A or B is calculated as the percentage of total biopotency of all peaks. The loss on drying is not more than 10 percent when dried in vacuum at 60 °C for 2 hours.
(b) Approvals. Approvals for Type A medicated articles containing the specified levels of monensin activity granted to firms identified by sponsor numbers in §510.600(c) of this chapter for the conditions of use indicated in paragraph (f) of this section are as follows:
(1) To 000986: 36.3 (for export only), 44, 45, or 60 grams per pound, paragraphs (f) (1)(i) and (4) of this section.
(2) To 000986: 110 grams per lb., paragraphs (f)(1) (i), (iii), (iv), (v), (ix), and (x).
(3) To 000986: 44 grams per lb. with 18 grams per lb. of roxarsone, 110 grams per lb. with 45 grams per lb. of roxarsone, paragraph (f)(1)(ii).
(4) To 000986: 45 and 60 grams per pound, as monensin sodium, paragraph (f)(2) of this section.
(5) To 066104: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xiii), (xx), and (xxi) of this section.
(6) To 000986: 45 and 60 grams per pound, as monensin sodium, paragraph (f)(5) of this section.
(7) To 000986: 20, 30, 45, 60, 80, and 90.7 grams per pound, as monensin sodium, paragraph (f)(3) of this section.
(8) To 046573: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraph (f)(1)(xiv) of this section.
(9) To 046573: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xv) and (xvi) of this section.
(10) To 016592: 45 and 60 grams per pound, as monensin sodium, paragraph (f)(1)(xvii) of this section.
(11) To 046573: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xiv), (xviii), (xix), (xxiii), (xxiv), (xxv), (xxvi), and (xxvii) of this section.
(12) To 066104: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraph (f)(1)(xxii) of this section.
(13) To 021930: 60 and 80 grams per pound, paragraph (f)(3)(v) of this section.
(14) To 000986: 60, 80, and 90.7 grams per pound, as monensin sodium, paragraph (f)(6) of this section.
(c) [Reserved]
(d) Special considerations. (1) Type C chicken feed containing monensin as the mycelial cake shall bear an expiration date of 90 days after its date of manufacture.
(2) Type C cattle feeds containing 30 grams or less monensin sodium per ton shall bear an expiration date of 30 days after its date of manufacture.
(3) Type C goat feeds shall bear an expiration date of 30 days after date of manufacture.
(4) [Reserved]
(5) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture.
(6) The labeling of all formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.
(7) The labeling of all Type A articles and Type B feeds (liquid and dry) containing monensin intended for use in cattle shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following caution statements:
(i) Monensin medicated cattle feed is safe for use in cattle only. Consumption by unapproved species may result in toxic reactions;
(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle.
(iii) Must be thoroughly mixed in feeds before use;
(iv) Do not feed undiluted;
(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.
(vi) A withdrawal time has not been established for preruminating calves. Do not use in calves to be processed for veal.
(8) The labeling of complete feeds containing monensin intended for use in cattle shall bear the caution statements specified in paragraphs (d) (6) and (7) (i) and (v) of this section.
(9) The labeling of Type A articles containing monensin intended for use in chickens shall bear the caution statements specified in paragraphs (d) (6) and (7) (iii) and (iv) of this section.
(10) The labeling of all Type A articles and Type B feeds (liquid and dry) containing monensin intended for use in goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following caution statements:
(i) Monensin medicated goat feed is safe for use in goats only. Consumption by unapproved species may result in toxic reactions.
(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin could be fatal to goats.
(iii) Must be thoroughly mixed in feeds before use.
(iv) Do not feed undiluted.
(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.
(11) The labeling of complete feeds containing monensin intended for use in goats shall bear the caution statements specified in paragraphs (d)(6) and (d)(10) (i) and (v) of this section.
(12) Mixing directions for liquid feeds requiring recirculation or agitation:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(13) The labeling of Type B and Type C (liquid and dry) medicated feeds intended for use in dairy cows shall bear the following caution statements: You may notice: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin.
(e) Related tolerances. See §556.420 of this chapter.
(f) Conditions of use. It is used as follows:
(1) Broiler chickens—(i) Amount per ton. Monensin, 90–110 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as monensin or monensin sodium.
(ii) Amount per ton. Monensin, 90–110 grams, plus roxarsone 45.4 grams (0.005 percent).
(a) Indications for use. Growth promotion and feed efficiency, improving pigmentation; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin or monensin sodium.
(iii) Amount per ton. Monensin, 90–110 grams plus bacitracin, 5–25 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin methylene disalicylate provided by No. 046573 in §510.600(c) of this chapter; as monensin sodium.
(iv) Amount per ton. Monensin, 90–110 grams plus bacitracin, 10 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as zinc bacitracin provided by No. 046573 in §510.600(c) of this chapter; as monensin sodium.
(v) Amount per ton. Monensin, 90–110 grams plus bacitracin, 10–30 grams.
(a) Indications for use. For improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as zinc bacitracin provided by No. 046573 in §510.600(c) of this chapter; as monensin sodium.
(vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 to 2 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; do not feed to laying chickens. Bambermycins provided by No. 016592 in §510.600(c) of this chapter.
(vii) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 gram; plus roxarsone, 22.7 to 45.4 grams
(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; use as sole source of organic arsenic; withdraw 5 d before slaughter; do not feed to laying chickens. Bambermycins provided by No. 016592 in §510.600(c) of this chapter; roxarsone provided by No. 046573.
(viii) Amount per ton. Monensin, 90 to 110 grams plus oxytetracycline, 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air-sac infection) caused by Mycoplasma gallisepticum and Escherichia coli.
(b) Limitations. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; do not feed to laying chickens; feed continuously as sole ration; as monensin sodium.
(ix) Amount per ton. Monensin, 90–110 grams plus lincomycin, 2 grams.
(a) Indications for use. For increase in rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; to be fed as a sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as monensin sodium.
(x) Amount per ton. Monensin, 90–110 grams plus lincomycin, 2 grams and roxarsone, 15–45 grams.
(a) Indications for use. For increase in rate of weight gain; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as roxarsone provided by No. 046573, §510.600(c) of this chapter; as monensin sodium provided by No. 000986, §510.600(c) of this chapter; as lincomycin provided by No. 000009, §510.600(c) of this chapter; as a combination provided by No. 000009, §510.600(c) of this chapter.
(xi) Amount per ton. Monensin, 90 to 110 grams, plus lincomycin, 2 grams and roxarsone, 15 to 30 grams.
(a) Indications for use. For increase in rate of weight gain, improved feed efficiency, improved pigmentation, and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as roxarsone provided by No. 046573 in §510.600(c) of this chapter; as monensin sodium provided by No. 000986 in §510.600(c) of this chapter; as lincomycin provided by No. 000009 in §510.600(c) of this chapter; as a combination provided by No. 000009 in §510.600(c) of this chapter.
(xii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 10 to 25 grams, and roxarsone, 11.3 to 45.4 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati; for increased rate of weight gain and for improved feed efficiency.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in §510.600 of this chapter; as bacitracin methylene disalicylate provided by No. 046573 in §510.600 of this chapter; as roxarsone provided by No. 011526 or 046573 in §510.600 of this chapter.
(xiii) Amount per ton. Monensin, 90 to 110 grams, plus 5 grams virginiamycin.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati; for increased rate of weight gain and improved feed efficiency.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium provided by No. 000986 in §510.600 of this chapter; virginiamycin provided by No. 066104 in §510.600 of this chapter.
(xiv) Amount per ton. Monensin, 90 to 110 grams, plus 500 grams chlortetracycline.
(a) Indications for use. As an aid in the reduction of mortality due to Escherichia coli infections susceptible to such treatment. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed for 5 days as the sole ration; withdraw 24 hours before slaughter; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; not to be fed continuously for more than 5 days; as monensin sodium; as chlortetracycline hydrochloride provided by Nos. 046573 and 048164 in §510.600(c) of this chapter.
(xv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 10 grams, and roxarsone, 15 grams (0.0017 percent).
(a) Indications for use. For increase in rate of weight gain; for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; feed must be used within 4 weeks of manufacture; as monensin sodium; as bacitracin zinc provided by No. 046573 in §510.600(c) of this chapter; as roxarsone provided by No. 046573 in §510.600(c) of this chapter.
(xvi) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams, and roxarsone, 15 to 45.4 grams (0.0017 percent to 0.005 percent).
(a) Indications for use. For improved feed efficiency; for improved pigmentation by enhancing carotenoid and xanthophyll utilization; for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; feed must be used within 4 weeks of manufacture; as monensin sodium; as bacitracin zinc provided by No. 046573 in §510.600(c) of this chapter; as roxarsone provided by No. 046573 in §510.600(c) of this chapter.
(xvii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90 to 110 grams plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. For increased rate of weight gain; and as an aid in prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; use as sole source of organic arsenic; withdraw 5 d before slaughter; do not feed to laying chickens. Bambermycins provided by No. 016592 in §510.600(c) of this chapter; roxarsone provided by No. 046573.
(xviii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 50 grams, and roxarsone, 22.7 to 34.0 grams (0.0025 percent to .00375 percent).
(a) Indications for use. For increase in rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp or other organisms susceptible to bacitracin methylene disalicylate.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in §510.600(c) of this chapter; as bacitracin methylene disalicylate provided by No. 046573 in §510.600(c) of this chapter; as roxarsone provided by No. 046573 in §510.600(c) of this chapter.
(xix) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 50 grams, and roxarsone, 22.7 to 45.4 grams (0.0025 percent to .005 percent).
(a) Indications for use. For increased rate of weight gain; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in §510.600(c) of this chapter; as bacitracin methylene disalicylate provided by No. 046573 in §510.600(c) of this chapter; as roxarsone provided by No. 046573 in §510.600(c) of this chapter.
(xx) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 5 to 15 grams, and roxarsone, 22.7 grams (0.0025 percent).
(a) Indications for use. For incease in rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in §510.600(c) of this chapter; as virginiamycin provided by No. 066104 in §510.600(c) of this chapter; roxarsone provided by Nos. 046753 and 011526 in §510.600(c) of this chapter.
(xxi) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 5 to 15 grams.
(a) Indications for use. For increase in rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium provided by No. 000986 in §510.600 of this chapter; virginiamycin provided by No. 066104 in §510.600 of this chapter.
(xxii) Amount per ton. Monensin, 90 to 110 grams plus oxytetracycline, 500 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. Mivati, and E. maxima; as an aid in the reduction of mortality due to air-sacculities (air-sac infection) caused by Escherichia coli sensitive to oxytetracycline.
(b) Limitations. Feed for 5 days as sole ration. Do not feed to laying chickens. Withdraw 24 hours before slaughter. As monensin sodium provided by No. 000986 in §510.600(c) of this chapter. As mono-alkyl (C8-C18) trimethylammonium oxytetracycline provided by No. 066104 in §510.600(c) of this chapter.
(xxiii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams, and roxarsone, 22.7 to 45.4 grams (0.0025 percent to 0.005 percent).
(a) Indications for use. For improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in §510.600(c) of this chapter; as bacitracin zinc provided by No. 046573 in §510.600(c) of this chapter; as roxarsone provided by No. 046573 in §510.600(c) of this chapter.
(xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 4 to 50 grams.
(xxv) Amount per ton. Monensin, 90 to 110 grams plus bacitracin, 4 to 50 grams.
(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin zinc provided by No. 046573 in §510.600(c) of this chapter, as monensin sodium.
(xxvi) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 to 200 grams and roxarsone 22.7 to 34.0 grams.
(a) Indications for use. As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of weight gain and improved feed efficiency.
(b) Limitations. For broiler chickens only. Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Do not feed to laying hens. To control necrotic enteritis, start medication at first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of infection. Use continuously for 5 to 7 days or as long as clinical signs persist, then reduce dosage to prevention level. Animals should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness. As roxarsone and bacitracin methylene disalicylate provided by No. 046573 in §510.600(c) of this chapter.
(xxvii) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 to 200 grams and roxarsone 22.7 to 45.4 grams.
(a) Indications for use. As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of weight gain.
(b) Limitations. For broiler chickens only. Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Do not feed to laying hens. To control necrotic enteritis, start medication at first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of infection. Use continuously for 5 to 7 days or as long as clinical signs persist, then reduce dosage to prevention level. Animals should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness. As roxarsone and bacitracin methylene disalicylate provided by No. 046573 in §510.600(c) of this chapter.
(xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin phosphate, 4 to 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. As monensin sodium and tylosin phosphate provided by No. 000986 in §510.600(c) of this chapter.
(xxix) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(xxx) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 100 to 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(2) Turkeys—(i) Amount per ton. Monensin, 54 to 90 grams.
(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis.
(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.
(ii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin methylene disalicylate, 4 to 50 grams.
(a) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, for increased rate of weight gain, and for improved feed efficiency.
(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylene disalicylate as provided by No. 046573 in §510.600(c) of this chapter.
(iii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin methylene disalicylate, 200 grams.
(a) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylene disalicylate.
(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylene disalicylate as provided by No. 046573 in §510.600(c) of this chapter.
(iv) Amount per ton. Monensin, 54 to 90 grams, with virginiamycin, 10 to 20 grams.
(a) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses, mature turkeys, and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.
(v) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 1 to 2 grams.
(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for improved feed efficiency in growing turkeys.
(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter.
(vi) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 2 grams.
(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter.
(3) Cattle—(i) Amount per ton. Monensin, 5–30 grams.
(a) Indications for use. Improved feed efficiency.
(b) Limitations. (1) Feed only to cattle being fed in confinement for slaughter. Feed continuously in complete feed at a rate of 50 to 360 milligrams of monensin per head per day; as monensin sodium. Complete feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions as defined in paragraph (d)(12) of this section. The liquid feed must bear caution statement as follows: Inadequate mixing, (recirculation or agitation), of liquid feeds has resulted in increased monensin concentration which has been fatal to cattle.
(2) An approved physically stable monensin liquid feed will not be subject to the requirements for mixing directions defined in paragraph (d)(12) of this section. A manufacturer may secure approval of a physically stable liquid feed by:
(i) Either filing an NADA for the product or by establishing a master file containing data to support the stability of its product;
(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental NADA to establish physical stability; and
(iii) Requesting No. 000986 in §510.600(c) of this chapter to file a supplemental NADA to provide for the use of its monensin Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the agency will approve the supplemental NADA. The approval will provide a basis for the individual liquid feed manufacturer to manufacture the liquid medicated feed under a medicated feed mill license described in the master file. A manufacturer who seeks to market a physically unstable monensin liquid feed with mixing directions different from the standard established in paragraph (d)(12) of this section may also follow this procedure.
(ii) Amount per ton. Monensin, 5 to 30 grams, plus tylosin, 8 to 10 grams.
(a) Indications for use. Improved feed efficiency; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.
(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 360 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day; as monensin sodium; as tylosin phosphate. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds and shall conform to mixing instructions as in §558.625 (c).
(iii) Amount per ton. Monensin, 25 to 400 grams.
(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.
(b) Limitations. For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed.
(iv) [Reserved]
(v) Amount. 150 milligrams per pound (0.033 percent).
(a) Indications for use. For increased rate of weight gain and for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii.
(b) Limitations. As protein-mineral blocks to be fed free choice to cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers) on pasture which may require supplemental feed. Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. Do not allow horses or other equines access to formulations containing monensin (ingestion of monensin by equines has been fatal). Block's effectiveness in cull cows and bulls has not been established. Approval must comply with §510.455 of this chapter.
(vi) Amount per ton. Monensin, 25 to 400 grams.
(a) Indications for use. For improved feed efficiency; for prevention and control of coccidiosis due to E. bovis and E. zuernii.
(b) Limitations. Feed to mature reproducing beef cows. Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day.
(vii) Amount per ton. Monensin, 10 to 30 grams.
(a) Indications for use. For prevention and control of coccidiosis due to E. bovis and E. zuernii.
(b) Limitations. For feedlot cattle, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 360 milligrams per head per day.
(viii) Additional combinations. Monensin may be used for heifers being fed in confinement for slaughter with melengestrol acetate with or without tylosin as in §558.342.
(ix) Amount. To 000986: To make liquid Type B medicated feed containing 400 grams per ton monensin sodium with 150 grams per ton tylosin phosphate used to make a dry Type C medicated feed containing 21.4 to 26.8 grams per ton monensin plus 8 to 10 grams per ton tylosin.
(a) Indications for use. Improved feed efficiency; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.
(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously at the rate of 8.2 to 10.2 kilograms (18 to 22.5 pounds) of Type C medicated feed per head per day to supply 240 milligrams of monensin and 90 milligrams of tylosin per head per day; as monensin sodium; as tylosin phosphate. Do not allow horses or other equines access to feeds containing monensin. Ingestion of monensin by equines has been fatal. Safe use in unapproved species and breeding cattle has not been established. The liquid medicated feed must bear expiration date of 14 days after date of manufacture. The mixing directions for this liquid medicated feed stored in recirculation or agitation tank systems are as defined in paragraph (d)(12) of this section.
(x) Amount per ton. Monensin, 1,620 grams as monensin sodium (810 milligrams per pound).
(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.
(b) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:
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------------------------------------------------------------------------ International Ingredient Percent feed no.------------------------------------------------------------------------Monocalcium phosphate (21% phosphorus, 15% 29.49 6-01-082 calcium).....................................Sodium chloride (salt)........................ 24.25 6-04-152Dried cane molasses........................... 20.0 4-04-695Ground limestone (33% calcium) or calcium 13.75 6-02-632 carbonate (38% calcium)......................Cane molasses................................. 3.0 4-04-696Processed grain by-products (as approved by 5.0 AAFCO).......................................Vitamin/trace mineral premix\1\............... 2.5Monensin Type A article, 80 grams per pound... 1.01Antidusting oil............................... 1.0------------------------------------------------------------------------\1\Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium and ethylenediamine dihydroiodide (EDDI) must comply with the published requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).)
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(c) Limitations. Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement. The product's effectiveness in cull cows and bulls has not been established. Consumption by unapproved species may result in toxic reactions.
(xi) Amount per ton. Monensin, 10 to 200 grams.
(a) Indications for use. For prevention and control of coccidiosis due to E. bovis and E. zuernii.
(b) Limitations. For calves excluding veal calves. Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day.
(xii) Amount per ton. Monensin, 10 to 30 grams; plus tylosin, 8 to 10 grams.
(a) Indications for use. For improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.
(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously to provide 50 to 360 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 360 milligrams per head per day; and 60 to 90 milligram of tylosin per head per day.
(xiii) Amount per ton. Monensin, 11 to 22 grams.
(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.
(B) Limitations. Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See paragraphs (d)(2), (d)(5), (d)(6), (d)(7)(i), (d)(7)(ii), (d)(7)(iii), (d)(7)(vi), (d)(8), and (d)(13) of this section.
(xiv) Amount per ton. Monensin, 11 to 400 grams.
(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.
(B) Limitations. Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See paragraphs (d)(2), (d)(5), (d)(6), (d)(7)(i), (d)(7)(ii), (d)(7)(iii), (d)(7)(vi), (d)(8), and (d)(13) of this section.
(4) Replacement chickens intended for use as cage layers—(i) Amount per ton. Monensin, 90 to 110 grams.
(i)(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(ii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 4 to 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain, and improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(iii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(iv) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium; do not feed to chickens over 16 weeks of age.
(v) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 100 to 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(vi) Amount per ton. Monensin, 90 to 110 grams; bacitracin methylene disalicylate, 50 grams; plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. Use as sole source of organic arsenic. Do not feed to chickens over 16 weeks of age. Poultry should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness or paralysis. Withdraw 5 days before slaughter. As monensin sodium provided by 000986; bacitracin methylene disalicylate and roxarsone as provided by 046573 in §510.600(c) of this chapter.
(vii) Amount per ton. Monensin, 90 to 110 grams; bacitracin methylene disalicylate, 100 to 200 grams; plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(b) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams/ton). Do not feed to laying chickens. Use as sole source of organic arsenic. Do not feed to chickens over 16 weeks of age. Poultry should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness or paralysis. Withdraw 5 days before slaughter. As monensin sodium provided by 000986; bacitracin methylene disalicylate and roxarsone as provided by 046573 in §510.600(c) of this chapter.
(iv) Amount per ton. Monensin, 90 to 110 grams, plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(b) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Poultry should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness or paralysis. As monensin sodium provided by 000986; roxarsone as provided by 046573 in §510.600(c) of this chapter.
(5) Bobwhite quail—(i) Amount per ton. Monensin, 73 grams.
(ii) Indications for use. For the prevention of coccidiosis in growing bobwhite quail caused by Eimeria dispersa and E. Lettyae.
(iii) Limitations. Feed continuously as the sole ration; do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin.
(6) Goats—(i) Amount per ton. Monensin, 20 grams.
(a) Indications for use. For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae.
(b) Limitations. (1) Feed only to goats being fed in confinement. Do not feed to lactating goats. Feed continuously in Type C feed as monensin sodium. Type C feed may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions, as defined in paragraph (d)(12) of this section. The liquid feed must bear caution statement as follows: Inadequate mixing, (recirculation or agitation), of liquid feeds has resulted in increased monensin concentration which could be fatal to goats.
(2) An approved physically stable monensin liquid feed will not be subject to the requirements for mixing directions defined in paragraph (d)12) of this section. A manufacturer may secure approval of a physically stable liquid feed by:
(i) Either filing an NADA for the product or by establishing a master file containing data to support the stability of its product;
(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental NADA to establish physical stability; and
(iii) Requesting No. 000986 in §510.600(c) of this chapter to file a supplemental NADA to provide for the use of its monensin Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the agency will approve the supplemental NADA. The approval will provide a basis for the individual liquid feed manufacturer to manufacture the liquid medicated feed under a medicated feed mill license described in the master file. A manufacturer who seeks to market a physically unstable monensin liquid feed with mixing directions different from the standard established in paragraph (d)(12) of this section may also follow this procedure.
(ii) [Reserved]
(7) Monensin may also be used in combination with:
(i) Decoquinate alone or with tylosin as in §558.195.
(ii) Melengestrol acetate alone or with tylosin as in §558.342.
(iii) Ractopamine alone or in combination as in §558.500.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.355, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.360 Morantel tartrate.
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(a) Approvals. Type A medicated articles: 88 grams per pound to 066104 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.425 of this chapter.
(c) Special considerations. (1) Do not use in Type B or Type C medicated feeds containing bentonite.
(2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(d) Conditions of use—(1) Amount. 0.44 to 4.4 grams of morantel tartrate per pound of feed.
(2) Indications for use—(i) Cattle. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum).
(ii) Goats. For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus axei.
(3) Limitations. Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of slaughter; do not treat goats within 30 days of slaughter.
[46 FR 50950, Oct. 16, 1981, as amended at 47 FR 53352, Nov. 26, 1982; 51 FR 7399, Mar. 3, 1986; 51 FR 9005, Mar. 17, 1986; 52 FR 11642, Apr. 10, 1987; 59 FR 17922, Apr. 15, 1994; 66 FR 47963, Sept. 17, 2001]
§ 558.363 Narasin.
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(a) Approvals. Type A medicated articles containing specified levels of narasin approved for sponsors identified in §510.600(c) of this chapter for use as in paragraph (d) of this section are as follows:
(1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph (d)(1)(i) of this section.
(2) To 000986: 36, 45, 54, 72, and 90 grams per pound, with 10, 20, 50, and 80 percent roxarsone, paragraph (d)(1)(ii) of this section.
(3) To 000986: 36 grams per pound, with 36 grams per pound nicarbazin, paragraph (d)(1)(iii) of this section.
(4) To 016592: 36, 45, 54, 72, and 90 grams per pound, with 2 and 10 grams per pound bambermycins, paragraph (d)(1)(iv) of this section.
(5) To 016592: 45 grams per pound, with 4 and 10 grams per pound bambermycins, and 45.4, 90, and 227 grams per pound roxarsone, paragraph (d)(1)(vii) of this section.
(6) To 046573: 45 grams per pound with 10, 25, 30, 40, 50, 60, or 75 grams per pound bacitracin methylene disalicylate and 45.4, 90, or 227 grams per pound roxarsone, paragraphs (d)(1)(viii) and (d)(1)(ix) of this section.
(7) To 046573: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this section.
(b) Tolerances. See §556.428 of this chapter.
(c) [Reserved]
(d) Conditions of use. It is used as follows:
(1) Broiler chickens—(i) Amount per ton. Narasin, 54 to 72 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal.
(ii) Amount per ton. Narasin, 54 to 72 grams, plus roxarsone 45.4 grams (0.005 percent).
(A) Indications for use. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati including some field strains of E. tenella which are more susceptible to roxarsone combined with narasin than to narasin alone.
(B) Limitations. For broiler chickens only; feed continuously as the sole ration; do not feed to laying chickens; may be fatal if accidentally fed to adult turkeys or to horses; withdraw 5 days before slaughter; as sole source of organic arsenic; not approved for use with pellet binders.
(iii) Amount per ton. Narasin, 27 to 45 grams, plus nicarbazin, 27 to 45 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these animals has been fatal. Withdraw 5 days before slaughter. The 2 drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 000986 in §510.600(c) of this chapter may be used in the combination.
(iv) Amount per ton. Narasin, 54 to 72 grams, plus bambermycins, 1 to 2 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. May be fatal if fed to adult turkeys, horses, or other equines. Narasin as provided by No. 000986; bambermycins by No. 016592 in §510.600(c) of this chapter.
(v) Amount per ton. Narasin 54 to 72 grams, roxarsone 22.7 to 45.4 grams, and bacitracin methylene disalicylate 10 to 50 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, for increased rate of weight gain, and for improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. Use as sole source of organic arsenic. Drug overdose or lack of water may result in leg weakness. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, roxarsone by 046573, bacitracin methylene disalicylate by 046573 in §510.600(c) of this chapter.
(vi) Amount per ton. Narasin 54 to 72 grams, and bacitracin methylene disalicylate 10 to 50 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and E. tenella, for increased rate of weight gain, and for improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin methylene disalicylate by 046573 in §510.600(c) of this chapter.
(vii) Amount per ton. Narasin 54 to 72 grams, bambermycins 1 to 2 grams, and roxarsone 22.7 to 45.4 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys or horses or other equines access to formulations containing narasin. Ingestion of narasin by these animals has been fatal. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Narasin as provided by 000986 in §510.600(c) of this chapter, bambermycins by 016592, and roxarsone by 046573.
(viii) Amount per ton. Narasin, 54 to 72 grams, and bacitracin methylene disalicylate, 50 grams, with roxarsone, 22.7 to 45.4 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdose or lack of water intake may result in leg weakness or paralysis. Narasin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573 in §510.600(c) of this chapter.
(ix) Amount per ton. Narasin, 54 to 72 grams, and bacitracin methylene disalicylate, 100 to 200 grams, with roxarsone, 22.7 to 45.4 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdose or lack of water intake may result in leg weakness or paralysis. Narasin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573 in §510.600(c) of this chapter.
(x) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 to 50 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin zinc by 046573 in §510.600(c) of this chapter.
(xi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 grams.
(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin sodium and tylosin phosphate as provided by 000986 in §510.600(c) of this chapter.
(2) Narasin may also be used for broilers in combination with:
(i) Nicarbazin with lincomycin as in §558.366.
(ii) Nicarbazin and bacitracin methylene disalicylate as in §558.366.
(iii) Bacitracin methylene disalicylate, nicarbazin, and roxarsone as in §558.366.
(iv) Nicarbazin and roxarsone as in §558.366.
[51 FR 29098, Aug. 14, 1986
Editorial Note: For Federal Register citations affecting §558.363, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.364 Neomycin sulfate.
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(a) Approvals. Type A medicated article: 325 grams per pound to 000009 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.430 of this chapter.
(c) [Reserved]
(d) Conditions of use. Neomycin sulfate is used as follows:
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---------------------------------------------------------------------------------------------------------------- Neomycin Sulfate Combination Indications for Use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(1) 250 to 2,250 grams per ton (g/ .................... Cattle, swine, sheep, To provide 10 000009 t) of dry type C feed.. and goats. For milligrams (mg) of treatment and control neomycin sulfate of colibacillosis per pound of body (bacterial enteritis) weight per day for caused by Escherichia a maximum of 14 coli susceptible to days. The neomycin.. concentration of neomycin sulfate required in medicated feed must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects feed consumption. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed supplements..(2) 400 to 2,000 g/t of type C .................... Do..................... To provide 10 mg of 000009 milk replacer.. neomycin sulfate per pound of body weight per day for a maximum of 14 days. Amount consumed will vary depending on animal's consumption and weight. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only..----------------------------------------------------------------------------------------------------------------
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[64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000]
§ 558.365 Nequinate.
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(a) Approvals. Type A medicated articles: 4 percent to No. 051311 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.440 of this chapter.
(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(d) Conditions of use. It is used as follows:
(1) Broiler or fryer chickens—(i) Amount per ton. Nequinate, 18.16 grams.
(ii) Indications for use. An aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(iii) Limitations. Feed continuously as the sole ration.
(2) Roaster chickens or replacement chickens for caged layers—(i) Amount per ton. Nequinate, 18.16 grams (0.002 percent).
(ii) Indications for use. An aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(iii) Limitations. Feed continuously as the sole ration; do not feed to chickens over 16 weeks of age.
[40 FR 13959, Mar. 27, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2685, Jan. 26, 1987; 66 FR 45167, Aug. 28, 2001; 70 FR 32489, June 3, 2005]
§ 558.366 Nicarbazin.
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(a) Specifications. Type A medicated articles containing 25 percent nicarbazin.
(b) Approvals. See Nos. 000986, 060728, and 066104 in §510.600(c) of this chapter for use as in paragraph (d) of this section.
(c) Related tolerances. See §556.445 of this chapter.
(d) Conditons of use. It is used in chicken feed as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------27 to 45......................... Narasin 27 to 45.... Broiler chickens; Sec. 000986 prevention of 558.363(d)(1)(iii). coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.. Narasin 27 to 45 and Broiler chickens; Feed continuously 000986 bacitracin prevention of as sole ration. methylene coccidiosis caused by Withdraw 5 days disalicylate 4 to Eimeria tenella, E. before slaughter. 50. necatrix, E. Do not allow acervulina, E. maxima, turkeys, horses, E. brunetti, E. or other equines mivati; for increased access to rate of weight gain formulations and improved feed containing efficiency. narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate by 046573. Narasin 27 to 45 and Broiler chickens: For Feed continuously 046573 bacitracin prevention of as sole ration. Do methylene coccidiosis caused by not feed to laying disalicylate 50.. Eimeria tenella, E. hens. Withdraw 5 necatrix, E. days before acervulina, E. maxima, slaughter. Do not E. brunetti, and E. allow turkeys, mivati; as an aid in horses or other the prevention of equines access to necrotic enteritis formulations caused or complicated containing by Clostridium spp. or narasin. Ingestion other organisms of narasin by susceptible to these species has bacitracin.. been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 046573 in § 510.600(c) of this chapter.. Narasin 27 to 45 and Broiler chickens: For To control necrotic 046573 bacitracin prevention of enteritis, start methylene coccidiosis caused by medication at disalicylate 100 to Eimeria tenella, E. first clinical 200.. necatrix, E. signs of disease; acervulina, E. maxima, vary dosage based E. brunetti, and E. on the severity of mivati; as an aid in infection; the control of administer necrotic enteritis continuously for 5 caused or complicated to 7 days or as by Clostridium spp. or long as clinical other organisms signs persist, susceptible to then reduce bacitracin.. bacitracin to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 046573 in § 510.600(c) of this chapter.. Narasin 27 to 45, Broiler chickens; Feed continuously 046573 bacitracin prevention of as sole ration. methylene coccidiosis caused by Withdraw 5 days disalicylate 50, Eimeria tenella, E. before slaughter. and roxarsone 22.7 necatrix, E. Do not allow to 45.4.. acervulina, E. maxima, turkeys, horses or E. brunetti, and E. other equines mivati, as an aid in access to the prevention of formulations necrotic enteritis containing caused or complicated narasin. Ingestion by Clostridium spp. or of narasin by other organisms these species has susceptible to been fatal. Do not bacitracin, for feed to laying increased rate of hens. Use as sole weight gain, improved source of organic feed efficiency, and arsenic. Narasin improved pigmentation.. and nicarbazin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573.. Narasin 27 to 45, Broiler chickens: As an Feed continuously 000986 and bambermycins 1 aid in preventing as sole ration to 2. outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis; ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed coccidiosis; do efficiency.. not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bambermycins provided by No. 016592; nicarbazin and narasin by No. 066104 in § 510.600(c) of this chapter. Narasin 27 to 45 and Broiler chickens; Feed continuously 000986 Lincomycin 2 to 4. prevention of as sole ration. coccidiosis caused by Withdraw 5 days Eimeria tenella, E. before slaughter. necatrix, E. Do not allow acervulina, E. maxima, turkeys, horses, E. brunetti, E. or other equines mivati; for increased access to rate of weight gain formulations and improved feed containing efficiency. narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Narasin and nicarbazin as provided by 000986, lincomycin by 000009. Narasin 27 to 45 and Broiler chickens; for Feed continuously 000986 roxarsone 22.7 to prevention of as sole ration. 45.4. coccidiosis caused by Use as sole source Eimeria tenella, E. of organic necatrix, E. arsenic. Withdraw acervulina, E. maxima, 5 days before E. brunetti, and E. slaughter. Do not mivati; for increased allow turkeys, rate of weight gain, horses or other improved feed equines access to efficiency, and formulations improved pigmentation.. containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Use as sole source of organic arsenic. Narasin and nicarbazin as provided by 000986, roxarsone by 046573..90.8 to 181.6 (0.01 to 0.02 pct). Bacitracin methylene Broiler chickens: As an Feed continuously 066104 disalicylate 4 to aid in preventing as sole ration 50 and roxarsone outbreaks of cecal from time chicks 22.7 to 45.4. (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed outbreaks of efficiency, and coccidiosis. Feed improved pigmentation. as the sole source of organic arsenic; drug overdose or lack of water may result in leg weakness; do not use in flushing mashes. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by No. 066104; bacitracin methylene disalicylate and roxarsone by No. 046573 in § 510.600(c) of this chapter. Penicillin 2.4 to 50 Broiler chickens: As an Feed continuously 066104 aid in preventing as sole ration outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed outbreaks of efficiency. coccidiosis. Do not use in flushing mashes. Do not feed to chickens producing eggs for human consumption. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104 in § 510.600(c) of this chapter. Penicillin 2.4 to 50 Broiler chickens: As an Feed continuously 066104 and roxarsone 22.7 aid in preventing as sole ration to 45.4. outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed outbreaks of efficiency, and coccidiosis. Feed improved pigmentation. as the sole source of organic arsenic; drug overdose or lack of water may result in leg weakness; do not use in flushing mashes. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104; roxarsone by No. 046573 in § 510.600(c) of this chapter.113.5 (0.0125 pct)............... .................... Chickens; aid in Feed continuously 000986 preventing outbreaks as sole ration 060728 of cecal (Eimeria from time chicks 066104 tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis. ordinarily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bacitracin methylene Broiler chickens; aid ......do........... 060728 disalicylate 30. in preventing 066104 outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency. Bacitracin zinc 4 to Broiler chickens; aid For broiler 066104 50.. in preventing chickens only. outbreaks of cecal Feed continuously (Eimeria tenella) and as sole ration intestinal (E. from time chicks acervulina, E. maxima, are placed on E. necatrix, and E. litter until past brunetti) coccidiosis, the time when and for increased rate coccidiosis is of weight gain and ordinarily a improved feed hazard. efficiency.. Discontinue medication 4 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by 066104, bacitracin zinc by 046573.. Bambermycins 1 to 2. Broiler chickens; aid Feed continuously 057926 in preventing as sole ration outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a for increased rate of hazard; do not use weight gain and as a treatment for improved feed coccidiosis; do efficiency.. not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Nicarbazin as provided by 066104.. Bambermycins 1 to 2. Broiler chickens: For Feed continuously 016592 prevention of as sole ration. coccidiosis caused by Bambermycins Eimeria tenella, E. provided by No. necatrix, E. 016592 in § acervulina, E. 510.600(c) of this brunetti, E. mivati, chapter. and E. maxima; and for increased rate of weight gain and improved feed efficiency.. Lincomycin 2 Broiler chickens; aid Feed continuously 060728 (0.00044 pct). in preventing as sole ration 066104 outbreaks of secal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis; ordinarily a for increased rate of hazard; do not use weight gain.. as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter.. Roxarsone 22.7 ......do............... Feed continuously 060728 (0.0025).. as sole ration 066104 from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; as sole source of organic arsenic; do not use a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 5 days before slaughter. Roxarsone 22.7 ......do............... ......do........... 060728 (0.0025) plus 066104 lincomycin 2 (0.0004)..----------------------------------------------------------------------------------------------------------------
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[42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 FR 40887, July 13, 1979; 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June 5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar. 7, 2000; 66 FR 46706, Sept. 7, 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 63500, Dec. 7, 2001; 67 FR 30327, May 6, 2002; 71 FR 16224, Mar. 31, 2006; 71 FR 27957, May 15, 2006]
§ 558.369 Nitarsone.
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(a) Approvals. Type A medicated articles: 50 percent to 046573 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.60 of this chapter.
(c) [Reserved]
(d) Conditions of use. It is used as follows:
(1) Chickens and turkeys—(i) Amount. Nitarsone, 0.01875 percent.
(ii) Indications for use. As an aid in the prevention of blackhead.
(iii) Limitations. Early medication is essential to prevent spread of disease. Adequate drinking water must be provided near feeder at all times. The drug is not effective in preventing blackhead in birds infected more than 4 or 5 days. Discontinue use 5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues. The drug is dangerous for ducks, geese, and dogs. Overdosage or lack of water may result in leg weakness or paralysis. Use as sole source of arsenic.
(2) Turkeys—(i) Amount. Nitarsone 0.01875 percent, plus bacitracin methylene disalicylate or bacitracin zinc 4 to 50 grams per ton.
(ii) Indications for use. As an aid in the prevention of blackhead, and for increased rate of weight gain and improved feed efficiency.
(iii) Limitations. For growing turkeys. Feed continuously as sole ration. Early medication is essential to prevent spread of disease. Adequate drinking water must be provided near feeders at all times. Overdosage or lack of water may result in leg weakness or paralysis. The drug is not effective in preventing blackhead in birds infected more than 4 or 5 days. Discontinue use 5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues. The drug is dangerous for ducks, geese, and dogs. Use as sole source of arsenic.
[46 FR 47535, Sept. 29, 1981, as amended at 47 FR 14152, Apr. 2, 1982; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8460, Mar. 8, 1990; 57 FR 8578, Mar. 11, 1992; 63 FR 39028, July 21, 1998; 71 FR 16223, Mar. 31, 2006]
§ 558.376 Nitromide and sulfanitran.
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(a) Approvals. Type A medicated articles: 25 percent nitromide, 30 percent sulfanitran, with or without 5 percent roxarsone to 053501 in §510.600(c) of this chapter.
(b) Related tolerances. See §§556.220 and 556.680 of this chapter.
(c) Conditions of use. It is used for chickens as follows:
(1) Amount. 227 grams per ton nitromide (0.025 percent) and 272 grams per ton sulfanitran (0.03 percent).
(i) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, and E. acervulina.
(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter; from Type A articles containing not more than 25 percent nitromide and 30 percent sulfanitran.
(2) Amount. 227 grams per ton nitromide (0.025 percent) and 272 grams per ton sulfanitran (0.03 percent), plus 45.4 grams per ton roxarsone (0.005 percent).
(i) Indications for use. Prevention of coccidiosis caused by Eimeria tenella, E. necatrix, and E. acervulina; growth promotion and feed efficiency; improving pigmentation.
(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter; from Type A articles containing not more than 25 percent nitromide, 30 per cent sulfanitan, and 5 percent roxarsone; as sole source of organic arsenic.
[41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8460, Mar. 8, 1990]
§ 558.415 Novobiocin.
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(a) Approvals. Type A medicated articles: 25 grams of activity per pound to 000009 in §510.600(c) of this chapter. Type B medicated feeds: 17.5 grams per pound to 000009 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.460 of this chapter.
(c) Conditions of use. It is used in animal feeds as follows:
(1) Chickens—(i) Amount. Novobiocin, 6–7 mgs. per lb. body weight per day.
(a) Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.
(b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.
(ii) Amount. Novobiocin, 10–14 mgs. per lb. body weight per day.
(a) Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin.
(b) Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.
(2) Turkeys—(i) Amount. Novobiocin, 4–5 mgs. per lb. body weight per day.
(a) Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.
(b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying turkeys; feed 5 to 7 days; withdraw 4 days before slaughter.
(ii) Amount. Novobiocin, 5–8 mgs. per lb. body weight per day.
(a) Indications for use. Aid in the control of recurring outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin following initial treatment with 7–8 mgs. per pound body weight per day.
(b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter.
(iii) Amount. Novobiocin, 7–8 mgs. per lb. body weight per day.
(a) Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infection susceptible to novobiocin; treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin.
(b) Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter.
(3) Mink—(i) Amount. 20 mgs. per lb. body weight per day.
(ii) Indications for use. For treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms.
(iii) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed for 7 days.
(4) Ducks—(i) Amount. Novobiocin, 350 grams per ton.
(ii) Indications for use. Control of infectious serositis and fowl cholera in ducks caused by Pasteurella anatipestifer and P. multocida, susceptible to novobiocin.
(iii) Limitations. Administer, as sole ration, for 5 to 7 days, continue medication for 14 days if necessary, repeat if reinfection occurs; discontinue use at least 3 days before slaughter; not for use in laying ducks.
[40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987]
§ 558.430 Nystatin.
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(a) Approvals. Type A medicated articles: 20 grams of activity per pound to 046573 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.470 of this chapter.
(c) Conditions of use. It is used for chickens and turkeys as follows:
(1) Amount. 50 grams per ton.
(i) Indications for use. Chickens and turkeys; aid in control of crop mycosis and mycotic diarrhea (Candida albicans).
(ii) Limitations. Growing and laying chickens; growing turkeys.
(2) Amount. 100 grams per ton.
(i) Indications for use. Chickens and turkeys; treatment of crop mycosis and mycotic diarrhea (Candida albicans).
(ii) Limitations. Growing and laying chickens; growing turkeys; to be fed for 7 to 10 days.
[41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 57 FR 8578, Mar. 11, 1992]
§ 558.435 Oleandomycin.
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(a) Approvals. Type A medicated articles: 5 grams of activity per pound to 066104 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.480 of this chapter.
(c) Special considerations. Do not use bentonite in Type B or Type C medicated feeds containing oleandomycin. Oleandomycin refers to oleandomycin or feed-grade oleandomycin.
(d) Conditions of use. It is used in animal feed as follows:
(1) Chickens and turkeys—(i) Amount per ton. Oleandomycin, 1 to 2 grams.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency for broiler chickens and growing turkeys.
(2) Swine—(i) Amount per ton. Oleandomycin, 5 to 11.25 grams.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency in growing-finishing swine.
[40 FR 13959, Mar. 27, 1975, as amended at 44 FR 40283, July 10, 1979; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 66 FR 47963, Sept. 17, 2001]
§ 558.450 Oxytetracycline.
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(a) Approvals. Type A medicated articles:
(1) 10, 20, 30, 50, 100, and 200 grams per pound to 066104 in §510.600(c) of this chapter.
(2) 50 and 100 grams per pound to 048164 in §510.600(c) of this chapter.
(b) Special considerations. (1) In accordance with §558.5 labeling shall bear the statement: “FOR USE IN DRY ANIMAL FEED ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.”
(2) The articles in paragraph (a)(1) of this section contain an amount of mono-alkyl (C8–C18) trimethylammonium oxytetracycline expressed in terms of an equivalent amount of oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate base expressed in terms of an equivalent amount of oxytetracycline hydrochloride.
(3) The articles in paragraph (a)(2) of this section contain an amount of mono-alkyl (C8–C18) trimethylammonium oxytetracycline expressed in terms of an equivalent amount of oxytetracycline hydrochloride.
(c) Related tolerances. See §556.500 of this chapter.
(d)(1) Conditions of use. It is used in feed as follows:
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Table 1---------------------------------------------------------------------------------------------------------------- Oxytetracycline amount Combination Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 20 grams per ton (g/ .................... Sheep; increased rate ................... 066104, ton). of weight gain and 048164 improved feed efficiency..(ii) 10 to 50 g/ton.............. .................... 1. Chickens; increased Do not feed to Do. rate of weight gain chickens producing and improved feed eggs for human efficiency.. consumption. .................... 2. Growing turkeys; Do not feed to Do. increased rate of turkeys producing weight and improved eggs for human feed efficiency.. consumption. .................... 3. Swine; increased ................... Do. rate of weight and improved feed efficiency..(iii) 100 g/ton.................. .................... Turkeys; control of Feed continuously Do. hexamitiasis caused by for 7 to 14 days Hexamita meleagridis (d); do not feed susceptible to to turkeys oxytetracycline.. producing eggs for human consumption.(iv) 100 to 200 g/ton............ .................... Chickens; control of Feed continuously Do. infectious synovitis for 7 to 14 d; do caused by Mycoplasma not feed to synoviae; control of chickens producing fowl cholera caused by eggs for human Pasteurella multocida consumption; in susceptible to low calcium feed, oxytetracycline.. withdraw 3 d before slaughter.(v) 200 g/ton.................... .................... Turkeys; control of Feed continuously 066104, infectious synovitis for 7 to 14 d; 048164 caused by M. synoviae withdraw 5 d susceptible to before slaughter; oxytetracycline.. do not feed to turkeys producing eggs for human consumption.(vi) 400 g/ton................... .................... Chickens; control of Feed continuously Do. chronic respiratory for 7 to 14 d; do disease (CRD) and air not feed to sac infection caused chickens producing by M. gallisepticum eggs for human and Escherichia coli consumption; in susceptible to low calcium feeds, oxytetracycline.. withdraw 3 d before slaughter.(vii) 500 g/ton.................. .................... Chickens; reduction of Feed continuously 066104, mortality due to air for 5 d; do not 048164 sacculitis (air-sac- feed to chickens infection) caused by producing eggs for E. coli susceptible to human consumption; oxytetracycline.. withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.(viii) 0.05 to 0.1 milligram/ .................... Calves (up to 250 lb); Feed continuously; 066104, pound (mg/lb) of body weight for increased rate of in milk replacers 048164 daily.. weight gain and or starter feed. improved feed efficiency..(ix) 10 mg/lb of body weight .................... 1.Calves and beef and Feed continuously Do. daily.. nonlactating dairy for 7 to 14 d; in cattle; treatment of feed or milk bacterial enteritis replacers; for No. caused by E. coli and 048164, withdraw 5 bacterial pneumonia d before (shipping fever slaughter; for No. complex) caused by P. 066104, 0-day multocida susceptible withdrawal. to oxytetracycline.. .................... 2. Calves (up to 250 Feed continuously Do. lb); treatment of for 7 to 14 d; in bacterial enteritis milk replacers or caused by E. coli starter feed; for susceptible to No. 048164, oxytetracycline.. withdraw 5 d before slaughter; for No. 066104, 0- day withdrawal. .................... 3. Sheep; treatment of Feed continuously Do. bacterial enteritis for 7 to 14 d; caused by E. coli and withdraw 5 d bacterial pneumonia before slaughter. caused by P. multocida susceptible to oxytetracycline.. .................... 4. Swine; treatment of Feed continuously Do. bacterial enteritis for 7 to 14 d; for caused by E. coli and No. 048164, Salmonella withdraw 5 d choleraesuis before slaughter; susceptible to for No. 066104, oxytetracycline and zero-day treatment of bacterial withdrawal. pneumonia caused by P. multocida susceptible to oxytetracycline.. .................... 5. Breeding swine; Feed continuously Do. control and treatment for not more than of leptospirosis 14 d; for No. (reducing the 048164, withdraw 5 incidence of abortion d before and shedding of slaughter; for No. leptospirae) caused by 066104, zero-day Leptospira pomona withdrawal. susceptible to oxytetracycline..(x) 25 mg/lb of body weight...... .................... Turkeys; control of Feed continuously Do. complicating bacterial for 7 to 14 d; organisms associated withdraw 5 d with bluecomb before slaughter; (transmissible do not feed to enteritis; coronaviral turkeys producing enteritis) susceptible eggs for human to oxytetracycline.. consumption.(xi) 25 mg/head/day.............. .................... Calves (250 to 400 lb); ................... Do. increased rate of weight gain and improved feed efficiency..(xii) 75 mg/head/day............. .................... Growing cattle (over ................... Do. 400 lb); increased rate of weight gain; improved feed efficiency, and reduction of liver condemnation due to liver abscesses..(xiii) 0.5 to 2.0 g/head/day..... .................... Cattle; prevention and Feed 3 to 5 d Do. treatment of the early before and after stages of shipping arrival in fever complex.. feedlots.(xiv) 200 mg/colony.............. .................... Honey bees; control of Remove at least 6 Do. American foulbrood weeks prior to caused by Bacillus main honey flow. larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline..----------------------------------------------------------------------------------------------------------------
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(2) It is used in fish feed as follows:
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Table 2---------------------------------------------------------------------------------------------------------------- Oxytetracycline amount Combination Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 250 mg/kilogram of fish/d .................... Pacific salmon for For salmon not over 066104 (11.35 g/100 lb of fish/d).. marking of skeletal 30 g body weight; tissue.. administer as sole ration for 4 consecutive days; fish not to be liberated for at least 7 d following the last administration of medicated feed..(ii) 2.5 to 3.75 g/100 lb of fish/ .................... 1. Salmonids; control Administer in mixed 066104 d.. of ulcer disease ration for 10 d; caused by Hemophilus do not liberate piscium, furunculosis fish or slaughter caused by Aeromonas fish for food for salmonicida, bacterial 21 d following the hemorrhagic septicemia last caused by A. administration of liquefaciens, and medicated feed; do pseudomonas disease.. not administer when water temperature is below 9 °C (48.2 °F).. .................... 2. Catfish; control of Administer in mixed 066104 bacterial hemorrhagic ration for 10 d; septicemia caused by do not liberate A. liquefaciens and fish or slaughter pseudomonas disease.. fish for food for 21 d following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F).(iii) 1 g/lb of medicated feed... .................... Lobsters; control of Administer as sole 066104 gaffkemia caused by ration for 5 Aerococcus viridans.. consecutive days; withdraw medicated feed 30 d before harvesting lobsters..----------------------------------------------------------------------------------------------------------------
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(3) Oxytetracycline may be used in accordance with the provisions of this section in the combinations provided as follows:
(i) Carbadox as in §558.115 of this chapter.
(ii) Lasalocid as in §558.311.
(iii) Melengestrol acetate as in §558.342.
(iv) Robenidine hydrochloride in accordance with §558.515.
(v) Salinomycin as in §558.550.
[61 FR 51590, Oct. 3, 1996, as amended at 63 FR 41192, Aug. 3, 1998; 66 FR 32740, June 18, 2001; 66 FR 45167, Aug. 28, 2001; 66 FR 47963, Sept. 17, 2001; 67 FR 51081, Aug. 7, 2002; 69 FR 28821, May 19, 2004; 69 FR 51173, Aug. 18, 2004; 69 FR 62407, Oct. 26, 2004; 71 FR 27958, May 15, 2006; 71 FR 44887, Aug. 8, 2006]
§ 558.455 Oxytetracycline and neomycin.
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(a) Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.
(b) Sponsors. See No. 066104 in §510.600(c) of this chapter.
(c) Related tolerances. See §§556.430 and 556.500 of this chapter.
(d) Indications for use—(1) Chickens. It is used in feed as follows:
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---------------------------------------------------------------------------------------------------------------- Oxytetracycline and neomycin sulfate amount in grams per ton of feed Indications for use Limitations Sponsors----------------------------------------------------------------------------------------------------------------(i) 10 to 50............................. Chickens: For increased rate Feed continuously; do not 066104 of weight gain and improved feed to chickens producing feed efficiency. eggs for human consumption.(ii) 100 to 200.......................... Chickens: For control of Feed continuously for 7 to 066104 infectious synovitis caused 14 days (d); do not feed to by Mycoplasma synoviae; chickens producing eggs for control of fowl cholera human consumption; in low caused by Pasteurella calcium feed, withdraw 3 d multocida susceptible to before slaughter. oxytetracycline.(iii) 400................................ Chickens: For control of Feed continuously for 7 to 066104 chronic respiratory disease 14 d; do not feed to (CRD) and air sac infection chickens producing eggs for caused by M. gallisepticum human consumption; in low and Escherichia coli calcium feeds, withdraw 3 d susceptible to before slaughter. oxytetracycline.(iv) 500................................. Chickens: For reduction of Feed continuously for 5 d; 066104 mortality due to air do not feed to chickens sacculitis (air-sac- producing eggs for human infection) caused by E. consumption; withdraw 24 coli susceptible to hours before slaughter; in oxytetracycline. low calcium feeds withdraw 3 d before slaughter.----------------------------------------------------------------------------------------------------------------
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(2) Turkeys. It is used in feed as follows:
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---------------------------------------------------------------------------------------------------------------- Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton of feed............... Growing turkeys: For Feed continuously; do not 066104 increased rate of weight feed to turkeys producing gain and improved feed eggs for human consumption. efficiency.(ii) 100 g/ton of feed................... Turkeys: For control of Feed continuously for 7 to 066104 hexamitiasis caused by 14 d; do not feed to Hexamita meleagridis turkeys producing eggs for susceptible to human consumption. oxytetracycline.(iii) 200 g/ton of feed.................. Turkeys: For control of Feed continuously for 7 to 066104 infectious synovitis caused 14 d; withdraw 5 d before by M. synoviae susceptible slaughter; do not feed to to oxytetracycline. turkeys producing eggs for human consumption.(iv) To provide 25 mg/lb of body weight Turkeys: For control of Feed continuously for 7 to 066104 daily. complicating bacterial 14 d; withdraw 5 d before organisms associated with slaughter; do not feed to bluecomb (transmissible turkeys producing eggs for enteritis; coronaviral human consumption. enteritis) susceptible to oxytetracycline.----------------------------------------------------------------------------------------------------------------
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(3) Swine. It is used in feed as follows:
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---------------------------------------------------------------------------------------------------------------- Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton of feed............... Swine: For increased rate of ............................ 066104 weight gain and improved feed efficiency.(ii) To provide 10 mg/lb of body weight 1. Swine: For treatment of Feed continuously for 7 to 066104 daily. bacterial enteritis caused 14 d; withdraw 5 d before by E. coli and Salmonella slaughter. choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. 2. Breeding swine: For Feed continuously for not 066104 control and treatment of more than 14 d; withdraw 5 leptospirosis (reducing the d before slaughter. incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline.----------------------------------------------------------------------------------------------------------------
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(4) Cattle and sheep. It is used in feed as follows:
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---------------------------------------------------------------------------------------------------------------- Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 20 grams per ton of feed....... Sheep: For increased rate of ............................ 066104 weight gain and improved feed efficiency.(ii) To provide 0.05 to 0.1 mg/lb of body Calves (up to 250 lb): For Feed continuously; in milk 066104 weight daily.. increased rate of weight replacers or starter feed. gain and improved feed efficiency.(iii) To provide 10 mg/lb of body weight 1. Calves and beef and Feed continuously for 7 to 066104 daily. nonlactating dairy cattle: 14 d; in feed or milk For treatment of bacterial replacers. If symptoms enteritis caused by E. coli persist after using for 2 and bacterial pneumonia or 3 d, consult a (shipping fever complex) veterinarian. Treatment caused by P. multocida should continue 24 to 48 susceptible to hours beyond remission of oxytetracycline; treatment disease symptoms. A and control of withdrawal period has not colibacillosis (bacterial been established for use in enteritis) caused by E. preruminating calves. Do coli susceptible to not use in calves to be neomycin. processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter. 2. Calves (up to 250 lb): Feed continuously for 7 to 066104 For treatment of bacterial 14 d; in milk replacers or enteritis caused by E. coli starter feed. If symptoms susceptible to persist after using for 2 oxytetracycline; treatment or 3 d, consult a and control of veterinarian. Treatment colibacillosis (bacterial should continue 24 to 48 enteritis) caused by E. hours beyond remission of coli susceptible to disease symptoms. A neomycin. withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter. 3. Sheep: For treatment of Feed continuously for 7 to 066104 bacterial enteritis caused 14 d. If symptoms persist by E. coli and bacterial after using for 2 or 3 d, pneumonia caused by P. consult a veterinarian. multocida susceptible to Treatment should continue oxytetracycline; treatment 24 to 48 hours beyond and control of remission of disease colibacillosis (bacterial symptoms. Withdraw 5 d enteritis) caused by E. before slaughter. coli susceptible to neomycin.(iv) To provide 25 mg/head/day........... Calves (250 to 400 lb): For ............................ 066104 increased rate of weight gain and improved feed efficiency.(v) To provide 75 mg/head/day............ Growing cattle (over 400 ............................ 066104 lb): For increased rate of weight gain; improved feed efficiency, and reduction of liver condemnation due to liver abscesses.(vi) To provide 0.5 to 2.0 g/head/day.... Cattle: For prevention and Feed 3 to 5 d before and 066104 treatment of the early after arrival in feedlots. stages of shipping fever A withdrawal period has not complex. been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.----------------------------------------------------------------------------------------------------------------
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[71 FR 16225, Mar. 31, 2006]
§ 558.460 Penicillin.
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(a) Specifications. As penicillin procaine G or feed grade penicillin procaine.
(b) Sponsors. Type A medicated articles: To 066104, 100 and 227 grams per pound. To 046573, 100 and 227 grams per pound.
(c) Related tolerances. See §556.510 of this chapter.
(d) Conditions of use. (1) It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams Penicillin in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 2.4 to 50.................... .................... Chickens, turkeys, and Do not feed to 000069, pheasants; for poultry producing 046573. increased rate of eggs for human weight gain and consumption.. improved feed efficiency..(ii) 5 to 20..................... .................... Quail; for increased Quail; not over 5 Do. rate of weight gain weeks of age.. and improved feed efficiency..(iii) 10 to 50................... .................... Swine; for increased ................... Do. rate of weight gain and improved feed efficiency..----------------------------------------------------------------------------------------------------------------
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(2) Penicillin may be used in accordance with the provisions of this section in the combinations provided as follows:
(i) Amprolium in accordance with §558.55.
(ii) Amprolium plus ethopatbate in accordance with §558.58.
(iii) Hygromycin B in accordance with §558.274.
(iv) Nicarbazin alone or with roxarsone as in §558.366.
(v) Roxarsone and zoalene in accordance with §558.680.
(vi) Zoalene in accordance with §558.680.
[41 FR 11004, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 36995, July 19, 1977; 47 FR 42103, Sept. 24, 1982; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 58 FR 30120, May 26, 1993; 60 FR 39847, Aug. 4, 1995; 63 FR 36179, July 2, 1998; 65 FR 45880, July 26, 2000; 66 FR 47963, Sept. 17, 2001; 71 FR 16227, Mar. 31, 2006]
§ 558.464 Poloxalene.
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(a) Approvals. (1) Dry Type A medicated articles: 53 percent to 000069 in §510.600(c) of this chapter.
(2) Liquid Type A medicated articles: 99.5 percent to 000069 in §510.600(c) of this chapter.
(b) Conditions of use. (1) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle.
(2) Poloxalene dry Type A article and liquid Type A article must be thoroughly blended and evenly distributed in feed prior to use. This may be accomplished by adding the Type A article to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during exposure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.
[40 FR 39857, Aug. 29, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995
§ 558.465 Poloxalene free-choice liquid Type C feed.
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(a) Approvals. Type A medicated articles: 99.5 percent to 066104 in §510.600(c) of this chapter.
(b) Conditions of use. (1) For control of legume (alfalfa, clover) and wheat pasture bloat in cattle, use 7.5 grams of poloxalene per pound of liquid Type C feed (1.65 percent weight/weight). Each animal must consume 0.2 pound of Type C feed per 100 pounds of body weight daily for adequate protection.
(2) For control of legume (alfalfa, clover) bloat in cattle grazing of prebloom legumes, use 10.00 grams of poloxalene per pound of liquid Type C feed (2.2 percent weight/weight). Each animal must consume 0.15 pound of Type C feed per 100 pounds of body weight daily for adequate protection. If consumption exceeds 0.2 pound of Type C feed per 100 pounds of body weight daily, cattle should be changed to a Type C feed containing 7.5 grams of poloxalene per pound.
(3) Poloxalene liquid Type A article must be thoroughly blended and evenly distributed into a liquid Type C feed and offered to cattle in a covered liquid Type C feed feeder with lick wheels. The formula for the liquid Type C feed, on a weight/weight basis, is as follows: Ammonium polyphosphate 2.66 percent, phosphoric acid (75 percent) 3.37 percent, sulfuric acid 1.00 percent, water 10.00 percent, and molasses sufficient to make 100.00 percent, vitamins A and D and/or trace minerals may be added. One free-turning lick wheel per 25 head of cattle must be provided.
(4) The medicated liquid Type C feed must be introduced at least 2 to 5 days before legume consumption to accustom the cattle to the medicated liquid Type C feed and to lick wheel feedings. If the medicated liquid wheel Type C feed feeding is interrupted, this 2- to 5-day introductory feeding should be repeated.
[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 21281, Apr. 26, 1977; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001]
§ 558.485 Pyrantel tartrate.
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(a) Specifications. Type A medicated articles containing 9.6, 19.2, 48, or 80 grams per pound pyrantel tartrate.
(b) Approvals. See sponsors in §510.600(c) of this chapter for uses as in paragraph (e) of this section:
(1) No. 066104: 9.6, 19.2, and 80 grams per pound for use as in paragraph (e)(1) of this section.
(2) [Reserved]
(3) Nos. 010439, 011490, 011749, 016968, 017473, 017519, 017790, 043733, and 049685: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.
(4) [Reserved]
(5) No. 051311: 19.2 and 48 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.
(6) Nos. 034936 and 046987: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) and (e)(1)(ii) of this section.
(7) Nos. 000069 and 017135: 48 grams per pound for use as in paragraph (e)(2) of this section.
(c) Related tolerances. See §556.560 of this chapter.
(d) Special considerations. (1) See §500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.
(2) Do not mix in Type B or Type C medicated feeds containing bentonite.
(e) Conditions of use. It is used as follows:
(1) Swine—(i) Amount per ton. 96 grams (0.0106 percent).
(A) Indications for use. Aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.
(B) Limitations. Feed continuously as the sole ration in a Type C feed; withdraw 24 hours prior to slaughter.
(ii) Amount per ton. 96 grams (0.0106 percent).
(A) Indications for use. For the removal and control of large roundworm (Ascaris suum) infections.
(B) Limitations. Feed for 3 days as the sole ration in a Type C feed; withdraw 24 hours prior to slaughter.
(iii) Amount per ton. 800 grams (0.0881 percent).
(A) Indications for use. For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections.
(B) Limitations. As sole ration for a single therapeutic treatment in Type C feed; feed at the rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over; withdraw 24 hours prior to slaughter.
(iv) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and carbadox, 50 grams (0.0055 percent).
(A) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.
(B) Limitations. Do not feed to swine weighing over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in Type C feeds containing less than 15 percent crude protein.
(v) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and tylosin, 40 to 100 grams, as tylosin phosphate.
(A) Indications for use. For prevention of swine dysentery (vibrionic); aid in the prevention of migration and establishment of large roundworms (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp. ) infections.
(B) Limitations. Use 100 grams tylosin per ton for at least 3 weeks followed by 40 grams tylosin per ton until market weight; withdraw 24 hours before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(vi) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and tylosin 40 to 100 grams, as tylosin phosphate.
(A) Indications for use. Treatment and control of swine dysentery (vibrionic); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp. ) infections.
(B) Limitations. Administer tylosin in feed as tylosin phosphate after treatment with tylosin in drinking water as tylosin base; 0.25 grams per gallon in drinking water for 3 to 10 days, 40 to 100 grams tylosin per ton in feed for 2 to 6 weeks; withdraw 24 hours before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(vii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 40 grams, as lincomycin hydrochloride monohydrate.
(A) Indications for use. For control of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.
(B) Limitations. Feed as sole ration; for use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(viii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 grams, then 40 grams, as lincomycin hydrochloride monohydrate.
(A) Indications for use. For treatment and control of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.
(B) Limitations. Feed 100 grams per ton for 3 weeks or until signs of disease disappear, followed by 40 grams per ton; feed as sole ration; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(ix) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 grams, as lincomycin hydrochloride monohydrate.
(A) Indications for use. For treatment of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.
(B) Limitations. Feed 100 grams per ton 3 weeks or until signs of disease disappear, followed by 40 grams per ton; feed as sole ration; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(x) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 or 40 grams.
(A) Indications for use. For treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections.
(B) Limitations. Administer in accordance with paragraph (c)(2)(i), (c)(2)(ii), or (c)(2)(iii) of §558.325 and paragraph (e)(1)(ii)(B) of this section.
(xi) Amount per ton. Pyrantel tartrate, 800 grams (0.0881 percent) and lincomycin, 100 or 40 grams.
(A) Indications for use. For treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections.
(B) Limitations. Administer in accordance with paragraph (c)(2)(i), (c)(2)(ii), or (c)(2)(iii) of §558.325 and paragraph (e)(1)(iii)(B) of this section.
(xii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 200 grams as lincomycin hydrochloride monohydrate.
(A) Indications for use. For the reduction in severity of swine mycoplasma pneumonia caused by Mycoplasma hyopneumoniae; aid in the prevention of migration and establishment of large roundworms (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.
(B) Limitations. Feed as sole ration for 21 days; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter; consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(C) Sponsor. See No. 000009 in §510.600(c) of this chapter.
(2) Horses—(i) Amount. Feed continuously at the rate of 1.2 milligrams per pound (2.64 milligrams per kilogram) of body weight.
(A) Indications for use. Prevention of Strongylus vulgaris larval infections; control of adult large strongyles (S. vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum).
(B) Limitations. Administer either as a top-dress (not to exceed 20,000 grams per ton) or mixed in the horse's daily grain ration (not to exceed 1,200 grams per ton) during the time that the animal is at risk of exposure to internal parasites. Not for use in horses intended for food. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(ii) [Reserved]
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.485, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.500 Ractopamine.
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(a) Specifications. Type A medicated articles containing 9 or 45 grams of ractopamine hydrochloride per pound.
(b) Approvals. See No. 000986 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.570 of this chapter.
(d) Special considerations. (1) Labeling of Type B and Type C swine feeds shall bear the following:
(i) “Caution: Pigs fed PAYLEAN are at an increased risk for exhibiting the downer pig syndrome (also referred to as “slows,” “subs,” or “suspects”). Pig handling methods to reduce the incidence of downer pigs should be thoroughly evaluated prior to initiating use of PAYLEAN.”
(ii) “Not for use in breeding swine.”
(2) Tylosin in combinations as tylosin phosphate.
(3) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(e) Conditions of use. (1) Swine—
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---------------------------------------------------------------------------------------------------------------- Combination in grams/ Ractopamine in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 4.5.......................... .................... For increased rate of Feed continuously 000986 weight gain, improved as sole ration.. feed efficiency, and increased carcass leanness in finishing swine fed a complete ration containing at least 16 percent crude protein from 150 lb (68 kg) to 240 lb (109 kg) body weight..(ii) 4.5......................... Tylosin 40.......... Finishing swine: As in Feed continuously 000986 paragraph (e)(1)(i) of as sole ration this section; and for until market prevention of swine weight following dysentery (vibrionic).. the use of tylosin at 100 grams per ton (g/t) for at least 3 weeks..(iii) 4.5........................ Tylosin 100......... 1. Finishing swine: As Feed continuously 000986 in paragraph (e)(1)(i) as sole ration for 000986 of this section; and 21 days.. for prevention and/or Feed continuously control of porcine as sole ration for proliferative at least 3 weeks enteropathies followed by (ileitis) associated tylosin at 40 g/t with Lawsonia until market intracellularis.. weight.. 2. Finishing swine: As in paragraph (e)(1)(i) of this section; and for prevention of swine dysentery (vibrionic)..(iv) 4.5 to 18................... .................... For improved feed Feed continuously 000986 efficiency and as sole ration.. increased carcass leanness in finishing swine fed a complete ration containing at least 16 percent crude protein from 150 lb (68 kg) to 240 lb (109 kg) body weight..(v) 4.5 to 18.................... Tylosin 40.......... Finishing swine: As in Feed continuously 000986 paragraph (e)(1)(iv) as sole ration of this section; and until market for prevention of weight following swine dysentery the use of tylosin (vibrionic).. at 100 g/t for at least 3 weeks..(vi) 4.5 to 18................... Tylosin 100......... 1. Finishing swine: As Feed continuously 000986 in paragraph as sole ration for 000986 (e)(1)(iv) of this 21 days.. section; and for Feed continuously prevention and/or as sole ration for control of porcine at least 3 weeks proliferative followed by enteropathies tylosin at 40 g/t (ileitis) associated until market with Lawsonia weight.. intracellularis.. 2. Finishing swine: As in paragraph (e)(1)(iv) of this section; and for prevention of swine dysentery (vibrionic)..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Ractopame in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 8.2 to 24.6.................. .................... Cattle fed in Feed continuously 000986 confinement for as sole ration slaughter: For during the last 28 increased rate of to 42 days on weight gain and feed. Not for improved feed animals intended efficiency during the for breeding. last 28 to 42 days on feed.(ii) 8.2 to 24.6................. Monensin 10 to 30... Cattle fed in As in paragraph 000986 confinement for (e)(2)(i) of this slaughter: As in section; see paragraph (e)(2)(i) of § 558.355(d) this section; and for of this chapter. prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.(iii) [Reserved].................(iv) 8.2 to 24.6................. Monensin 10 to 30, Cattle fed in As in paragraph 000986 plus tylosin 8 to confinement for (e)(2)(i) of this 10. slaughter: As in section; see paragraph (e)(2)(i) of §§ this section; for 558.355(d) and prevention and control 558.625(c) of this of coccidiosis due to chapter. E. bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.(v) [Reserved]...................(vi) 9.8 to 24.6................. .................... Cattle fed in Feed continuously 000986 confinement for as sole ration slaughter: For during the last 28 increased rate of to 42 days on weight gain, improved feed. Not for feed efficiency, and animals intended increased carcass for breeding. leanness during the last 28 to 42 days on feed.(vii) 9.8 to 24.6................ Monensin 10 to 30... Cattle fed in As in paragraph 000986 confinement for (e)(2)(vi) of this slaughter: As in section; see paragraph (e)(2)(vi) § 558.355(d) of this section; and of this chapter. for prevention and control of coccidiosis due to E. bovis and E. zuernii.(viii) 9.8 to 24.6............... Monensin 10 to 30, Heifers fed in As in paragraph 000986 plus melengestrol confinement for (e)(2)(vi) of this acetate to provide slaughter: As in section; see 0.25 to 0.5 mg/head/ paragraph (e)(2)(vi) §§ day. of this section; for 558.342(d) and prevention and control 558.355(d) of this of coccidiosis due to chapter. Eimeria bovis and E. Melengestrol zuernii; and for acetate as suppression of estrus provided by No. (heat).. 000009 in § 510.600(c) of this chapter..(ix) 9.8 to 24.6................. Monensin 10 to 30, Cattle fed in As in paragraph 000986 plus tylosin 8 to confinement for (e)(2)(vi) of this 10. slaughter: As in section; see paragraph (e)(2)(vi) §§ of this section; for 558.355(d) and prevention and control 558.625(c) of this of coccidiosis due to chapter. E. bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.(x) 9.8 to 24.6.................. Monensin 10 to 30, Heifers fed in As in paragraph 000986 plus tylosin 8 to confinement for (e)(2)(vi) of this 021641 10, plus slaughter: As in section; see melengestrol paragraph (e)(2)(vi) §§ acetate to provide of this section; for 558.342(d), 0.25 to 0.5 mg/head/ prevention and control 558.355(d), and day. of coccidiosis due to 558.625(c) of this Eimeria bovis and E. chapter. zuernii; for reduction Melengestrol of incidence of liver acetate as abscesses caused by provided by Nos. Fusobacterium 000009 and 021641 necrophorum and in § Actinomyces 510.600(c) of this (Corynebacterium) chapter.. pyogenes; and for suppression of estrus (heat)..----------------------------------------------------------------------------------------------------------------
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[67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006]
§ 558.515 Robenidine hydrochloride.
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(a) Approvals. Type A medicated articles: 30 grams per pound to 046573 in §510.600(c) of this chapter.
(b) Special considerations. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use in Type B or Type C medicated feeds containing bentonite.
(c) Related tolerances. See §556.580 of this chapter.
(d) Conditions of use. It is used in feed for chickens as follows:
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----------------------------------------------------------------------------------------------------------------Robenidine hydrochloride in grams/ Combination in ton grams/ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------30 (0.0033 pct).................. .................... For broiler and fryer Feed continuously 046573 chickens: As an aid in as sole ration. Do the prevention of not feed to coccidiosis caused by layers. Withdraw 5 E. mivati, E. days prior to brunetti, E. tenella, slaughter.. E. acervulina, E. maxima, and E. necatrix.. Bacitracin (as For broiler and fryer Feed continuously 046573 bacitracin chickens: As an aid in as sole ration. Do methylene the prevention of not feed to laying disalicylate) 4 to coccidiosis caused by chickens. Withdraw 30. E. mivati, E. 5 days prior to brunetti, E. tenella, slaughter.. E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.. Bacitracin (as For broiler and fryer Feed continuously 046573 bacitracin chickens: As an aid in as sole ration. Do methylene the prevention of not feed to laying disalicylate) 27 to coccidiosis caused by chickens. Withdraw 50. E. mivati, E. 5 days prior to brunetti, E. tenella, slaughter.. E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.. Bacitracin (as For broiler and fryer Feed continuously 046573 bacitracin chickens: As an aid in as sole ration. Do methylene the prevention of not feed to laying disalicylate) 50. necrotic enteritis hens. Withdraw 5 caused or complicated days before by Clostridium spp. or slaughter.. other organisms susceptible to bacitracin.. Bacitracin (as For broiler and fryer To control a 046573 bacitracin chickens: As an aid in necrotic enteritis methylene the control of outbreak, start disalicylate) 100 necrotic enteritis medication at to 200. caused or complicated first clinical by Clostridium spp. or signs of disease; other organisms administer susceptible to continuously for 5 bacitracin.. to 7 days or as long as clinical signs persist, then reduce bacitracin methylene disalicylate to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter.. Bacitracin (as For broiler chickens: Feed continuously 046573 bacitracin As an aid in the as sole ration. methylene prevention of Use as the sole disalicylate) 50 coccidiosis caused by source of organic and roxarsone 22.7 E. mivati, E. arsenic; poultry to 45.4. brunetti, E. tenella, should have access E. acervulina, E. to water at all maxima, and E. times; drug necatrix. As an aid in overdose or lack the prevention of of water intake necrotic enteritis may result in leg caused or complicated weakness or by Clostridium spp. or paralysis. Do not other organisms feed to laying susceptible to chickens. Withdraw bacitracin. For 5 days prior to increased rate of slaughter.. weight gain, improved feed efficiency, and improved pigmentation.. Bacitracin (as For broiler chickens: To control necrotic 046573 bacitracin As an aid in the enteritis, start methylene prevention of medication at disalicylate) 100 coccidiosis caused by first clinical to 200 and E. mivati, E. signs of disease; roxarsone 22.7 to brunetti, E. tenella, vary bacitracin 45.4. E. acervulina, E. dosage based on maxima, and E. the severity of necatrix. As an aid in infection; the control of administer necrotic enteritis continuously for 5 caused or complicated to 7 days or as by Clostridium spp. or long as clinical other organisms signs persist, susceptible to then reduce bacitracin. For bacitracin to increased rate of prevention level weight gain, improved (50 g/ton). Use as feed efficiency, and the sole source of improved pigmentation.. organic arsenic; poultry should have access to water at all times; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.. Bacitracin (as For broiler and fryer Feed continuously 046573 bacitracin zinc) 4 chickens: As an aid in as sole ration. Do 046573 to 30. the prevention of not feed to laying coccidiosis caused by chickens. Withdraw E. mivati, E. 5 days prior to brunetti, E. tenella, slaughter.. E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.. Bacitracin (as For broiler and fryer Feed continuously 046573 bacitracin zinc) 27 chickens: As an aid in as sole ration. Do 046573 to 50. the prevention of not feed to laying coccidiosis caused by chickens. Withdraw E. mivati, E. 5 days prior to brunetti, E. tenella, slaughter.. E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.. Chlortetracycline For broiler and fryer Feed continuously 100 to 200. chickens: As an aid in as sole ration up the prevention of to 14 days. Do not coccidiosis caused by feed to chickens E. mivati, E. producing eggs for brunetti, E. tenella, human consumption. E. acervulina, E. Withdraw 5 days maxima, and E. prior to necatrix. For control slaughter.. of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.. Chlortetracycline For broiler and fryer Feed continuously 200 to 400. chickens: As an aid in as sole ration up the prevention of to 14 days. Do not coccidiosis caused by feed to chickens E. mivati, E. producing eggs for brunetti, E. tenella, human consumption. E. acervulina, E. Withdraw 5 days maxima, and E. prior to necatrix. For control slaughter.. of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline.. Chlortetracycline For broiler and fryer Feed continuously 046573 500. chickens: As an aid in as sole ration up the prevention of to 5 days. Do not coccidiosis caused by feed to chickens E. mivati, E. producing eggs for brunetti, E. tenella, human consumption. E. acervulina, E. Withdraw 5 days maxima, and E. prior to necatrix. As an aid in slaughter.. the reduction of mortality due to E. coli susceptible to chlortetracycline.. Lincomycin 2........ For broiler and fryer Feed continuously 000009 chickens: As an aid in as the sole the prevention of ration. Do not coccidiosis caused by feed to laying E. mivati, E. hens. Withdraw 5 brunetti, E. tenella, days before E. acervulina, E. slaughter.. maxima, and E. necatrix. For increase in rate of weight gain and improved feed efficiency.. Oxytetracycline 400. For broiler chickens: Feed continuously 066104 As an aid in the for 7 to 14 days. prevention of Do not feed to coccidiosis caused by chickens producing E. mivati, E. eggs for human brunetti, E. tenella, consumption. E. acervulina, E. Withdraw 5 days maxima, and E. before slaughter.. necatrix. For control of CRD and air sac infection caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline.. Roxarsone 22.5 to For broiler and fryer Feed continuously 046573 45.4 (0.005 chickens: As an aid in as the sole percent). the prevention of ration. Use as coccidiosis caused by sole source of E. mivati, E. organic arsenic. brunetti, E. tenella, Do not feed to E. acervulina, E. layers. Withdraw 5 maxima, and E. days prior to necatrix. For slaughter.. increased rate of weight gain..----------------------------------------------------------------------------------------------------------------
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[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.515, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.530 Roxarsone.
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(a) Specifications. Type A medicated articles containing 10, 20, 50, or 80 percent roxarsone.
(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 046573 for use of 10, 20, and 50 percent Type A medicated articles as in paragraph (d)(1)(i) of this section.
(2) No. 046573 for use of 10, 20, 50, and 80 percent Type A medicated articles as in paragraphs (d)(1) through (d)(3) of this section.
(c) Related tolerances. See §556.60 of this chapter.
(d) Conditions of use—(1) Chickens. It is used in chicken feed as follows:
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------------------------------------------------------------------------Roxarsone in Combinations grams per in grams per Indications Limitations Sponsor ton ton for use------------------------------------------------------------------------(i) 22.7 to .............. Growing Feed 046573 45.4 chickens: continuously For throughout increased growing rate of period; do weight gain, not feed to improved chickens feed producing efficiency, eggs for and improved human pigmentation consumption; . withdraw 5 days before slaughter; as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness.------------------------------------------------------------------------(ii) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 10 to 50 chickens: As paragraph in paragraph (d)(1)(i) of (d)(1)(i) of this section. this Chlortetracyc section. line as provided by No. 046573 in § 510.600(c) of this chapter.------------------------------------------------------------------------(iii) 22.7 Chlortetracycl Growing As in ........... to 45.4 ine 100 to chickens: As paragraph 200 in paragraph (d)(1)(i) of (d)(1)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. infectious Chlortetracyc synovitis line as caused by provided by Mycoplasma No. 046573 in synoviae § susceptible 510.600(c) of to this chapter. chlortetracy cline.------------------------------------------------------------------------(iv) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 200 to chickens: As paragraph 400 in paragraph (d)(1)(i) of (d)(1)(i) of this section this except feed section; and continuously for control for 7 to 14 of chronic days. respiratory Chlortetracyc disease line as (CRD) and provided by air sac No. 046573 in infection § caused by M. 510.600(c) of gallisepticu this chapter. m and Escherichia coli susceptible to chlortetracy cline.------------------------------------------------------------------------(v) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 500 chickens: As paragraph in paragraph (d)(1)(i) of (d)(1)(i) of this section this except feed section; and continuously for for 5 days. reduction of Chlortetracyc mortality line as due to E. provided by coli No. 046573 in infections § susceptible 510.600(c) of to this chapter. chlortetracy cline.------------------------------------------------------------------------
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(2) Turkeys. It is used in turkey feed as follows:
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------------------------------------------------------------------------Roxarsone in Combinations grams per in grams per Indications Limitations Sponsor ton ton for use------------------------------------------------------------------------(i) 22.7 to .............. Growing Feed 046573 45.4 turkeys: For continuously increased throughout rate of growing weight gain, period; do improved not feed to feed turkeys efficiency, producing and improved eggs for pigmentation human . consumption; withdraw 5 days before slaughter; as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness.------------------------------------------------------------------------(ii) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 10 to 50 turkeys: As paragraph in paragraph (d)(2)(i) of (d)(2)(i) of this section. this Chlortetracyc section. line as provided by No. 046573 in § 510.600(c) of this chapter.------------------------------------------------------------------------(iii) 22.7 Chlortetracycl Growing As in ........... to 45.4 ine 200 turkeys: As paragraph in paragraph (d)(2)(i) of (d)(2)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. infectious Chlortetracyc synovitis line as caused by provided by Mycoplasma No. 046573 in synoviae § susceptible 510.600(c) of to this chapter. chlortetracy cline.------------------------------------------------------------------------(iv) 22.7 to Chlortetracycl 1. Growing As in ........... 45.4 ine 400 turkeys: As paragraph in paragraph (d)(2)(i) of (d)(2)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. hexamitiasis Chlortetracyc caused by line as Hexamita provided by meleagrides No. 046573 in susceptible § to 510.600(c) of chlortetracy this chapter. cline. 2. Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracy cline.------------------------------------------------------------------------(v) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 25 mg/lb turkeys: As paragraph body weight in paragraph (d)(2)(i) of daily (d)(2)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. complicating Chlortetracyc bacterial line as organisms provided by associated No. 046573 in with § bluecomb 510.600(c) of (transmissib this chapter. le enteritis, coronaviral enteritis) susceptible to chlortetracy cline.------------------------------------------------------------------------
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(3) Swine. It is used in swine feed as follows:
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------------------------------------------------------------------------Roxarsone in Combinations grams per in grams per Indications Limitations Sponsor ton ton for use------------------------------------------------------------------------(i) 22.7 to .............. Growing and Feed 046573 34.1 finishing continuously swine: For throughout increased growing rate of period; weight gain withdraw 5 and improved days before feed slaughter; as efficiency. sole source of organic arsenic.------------------------------------------------------------------------(ii) 22.7 to Chlortetracycl Growing and Feed for not ........... 34.1 ine 400 (to finishing more than 14 administer 10 swine: As in days; mg/lb body paragraph withdraw 5 weight) (d)(3)(i) of days before this slaughter; as section; and sole source for of organic treatment of arsenic. bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracy cline.------------------------------------------------------------------------(iii) 181.5 .............. Growing and Feed for not 046573 finishing more than 6 swine: For consecutive the days; if treatment of improvement swine is not dysentery. observed, consult a veterinarian; withdraw 5 days before slaughter; as a sole source of organic arsenic; animals must consume enough medicated feed to provide a therapeutic dose.------------------------------------------------------------------------(iv) 181.5 Chlortetracycl Growing and Feed for not ........... ine 10 to 50 finishing more than 6 swine: As in consecutive paragraph days; if (d)(3)(i) of improvement this is not section; and observed, for consult a treatment of veterinarian; swine withdraw 5 dysentery. days before slaughter; as a sole source of organic arsenic; animals must consume enough medicated feed to provide a therapeutic dose.------------------------------------------------------------------------(v) 181.5 Chlortetracycl Growing and Feed for not ........... ine 400 (to finishing more than 6 administer 10 swine: As in consecutive mg/lb body paragraph days; if weight) (d)(3)(iii) improvement of this is not section; and observed, for consult a treatment of veterinarian; bacterial withdraw 5 enteritis days before caused by E. slaughter; as coli and S. a sole source choleraesuis of organic and arsenic; bacterial animals must pneumonia consume caused by P. enough multocida medicated susceptible feed to to provide a chlortetracy therapeutic cline. dose.------------------------------------------------------------------------
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(4) Permitted combinations. It may be used in accordance with this section in combination with:
(i) Aklomide as in §558.35.
(ii) Amprolium as in §558.55.
(iii) Amprolium and ethopabate as in §558.58.
(iv) Bacitracin methylene disalicylate as in §558.76.
(v) Bacitracin zinc as in §558.78.
(vi) Bambermycins and bambermycins plus certain anticoccidials as in §558.95.
(vii) Chlortetracycline as in §558.128.
(viii) Clopidol as in §558.175.
(ix) Decoquinate alone or in combination as in §558.195.
(x) Diclazuril alone or in combination as in §558.198.
(xi) Halofuginone alone or in combination as in §558.265.
(xii) Lasalocid alone or in combination as in §558.311.
(xiii) Monensin alone or in combination as in §558.355.
(xiv) Narasin alone or in combination as in §558.363.
(xv) Nequinate as in §558.365.
(xvi) Nicarbazin alone or in combination as in §558.366.
(xvii) Nitromide and sulfanitran as in §558.376.
(xviii) Penicillin and zoalene as in §558.680.
(xix) Robenidine hydrochloride as in §558.515.
(xx) Salinomycin alone or in combination as in §558.550.
(xxi) Semduramicin alone or in combination as in §558.555.
(xxii) Sulfadimethoxine, ormetoprim as in §558.575.
(xxiii) Zoalene alone or in combination as in §558.680.
[46 FR 52331, Oct. 27, 1981]
Editorial Note: For Federal Register citations affecting §558.530, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.550 Salinomycin.
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(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin activity per pound (as salinomycin sodium biomass).
(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section:
(1) No. 046573 for use as in paragraph (d) of this section.
(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), (d)(3)(i), and (d)(4) of this section.
(3) No. 048164 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) of this section.
(c) [Reserved]
(d) Conditions of use. (1) Broilers: It is used as follows:
(i)(a) Amount per ton. Salinomycin 40 to 60 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(c) Limitations. Feed continuously as sole ration. Do not feed to layers. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.
(ii)(a) Amount per ton. Salinomycin 40 to 60 grams and roxarsone 45.4 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone.
(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 011526 or 046573 in §510.600(c) of this chapter.
(iii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 30 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati for incresed rate of weight gain and improved feed efficiency.
(c) Limitation. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentially fed to adult turkeys or horses. Bacitracin methylene disalicylate as provided by No. 046573 in §510.600(c) of this chapter.
(iv)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone; for increased rate of weight gain.
(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone and bacitracin as provided by No. 046573 in §510.600(c) of this chapter.
(v)(a) Amount per ton. Salinomycin 40 to 60 grams per ton with roxarsone 22.7 to 45.4 grams per ton.
(b) Indications for use. For the prevention of coccidiosis caused by Eimera tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidently fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 in §510.600(c) of this chapter.
(vi)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin MD as provided by No. 046573 in §510.600(c) of this chapter.
(vii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin zinc 10 to 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.
(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 046573 in §510.600(c) of this chapter.
(viii)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 45.4 grams and bacitracin zinc 4 to 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone; for increased rate of weight gain and improved feed efficiency.
(c) Limitations. See paragraph (d)(1)(iv)(c) of this section.
(ix)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 34.1 grams and bacitracin zinc 10 to 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 and bacitracin as provided by No. 046573 in §510.600(c) of this chapter.
(x)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers or to chickens over 16 weeks of age. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.
(xi)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 to 15 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.
(c) Limitations. See paragraph (d)(1)(x)(c) of this section.
(xii) (a) Amount per ton. Salinomycin 40 to 60 grams, virginiamycin 5 grams, and roxarsone 45.4 grams.
(b) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone, and for improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Withdraw 5 days prior to slaughter. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter. Roxarsone as provided by No. 046573 in §510.600(c) of this chapter.
(xiii)(a) Amount per ton. Salinomycin 40 to 60 grams and lincomycin 2 to 4 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and for improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. Do not allow horses, adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to this feed. Ingestion by these species may result in severe gastrointestinal effects or may be fatal. Lincomycin hydrochloride monohydrate as provided by No. 000009 in §510.600(c) of this chapter.
(xiv)(a) Amount per ton. Salinomycin 40 to 60 grams, roxarsone 45.4 grams, and lincomycin 2 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than to salinomycin alone, and for improved feed efficiency.
(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Drug overdose or lack of water may result in leg weakness. Do not feed to layers. Do not allow horses, adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to this feed. Ingestion by these species may result in severe gastrointestinal effects or may be fatal. Withdraw 5 days before slaughter. Lincomycin hydrochloride monohydrate as provided by No. 000009 in §510.600(c) of this chapter. Roxarsone as provided by No. 046573 in §510.600(c) of this chapter.
(xv)(a) Amount per ton. Salinomycin 40 to 60 grams, chlortetracycline 500 grams, and roxarsone 45.4 grams.
(b) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
(c) Limitations. Do not feed to layers. In feeds containing 0.8 percent dietary calcium, not to be fed for more than 5 days. Not approved for use with pellet binders. Withdraw 5 days before slaughter. May be fatal if accidentally fed to adult turkeys or to horses. Chlortetracycline as provided by Nos. 046573 and 048164; roxarsone as provided by No. 046573; and salinomycin as provided by Nos. 046573 and 016592 in §510.600(c) of this chapter.
(xvi)(a) Amount per ton. Salinomycin 40 to 60 grams and chlortetracycline 500 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E., necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
(c) Limitations. Do not feed to layers. In feeds containing 0.8 percent dietary calcium. Not to be fed for more than 5 days. Not approved for use with pellet binders. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 046573 and 048164; salinomycin as provided by Nos. 046573 and 016592 in §510.600(c) of this chapter.
(xvii)(A) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 34.1 or 45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.
(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than to salinomycin alone; for increased rate of weight gain. Use of 34.1 or 45.4 grams per ton roxarsone is indicated to meet the E. tenella challenge which varies with environmental and management conditions.
(C) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to laying chickens. May be fatal if accidentally fed to adult turkeys or horses. Poultry should have access to drinking water at all times. Overdosage or lack of water may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573 in §510.600(c) of this chapter. Roxarsone and bacitracin as provided by No. 046573 in §510.600(c) of this chapter.
(xviii)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.
(B) Indications for use. For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(C) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by Nos. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in §510.600(c) of this chapter.
(xix)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 grams.
(B) Indications for use. For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(C) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in §510.600(c) of this chapter.
(xx)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 50 grams.
(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(C) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) in this chapter.
(xxi)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 100 to 200 grams.
(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(C) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) in this chapter.
(xxii) Amount per ton. Salinomycin, 40 to 60 grams; plus tylosin, 4 to 50 grams.
(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by 046573; tylosin phosphate as provided by 000986 in §510.600(c) of this chapter.
(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 3 grams.
(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by Nos. 046573 and 016592; bambermycins by No. 016592 in §510.600(c) of this chapter.
(xxiv) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 2 grams; plus roxarsone, 45.4 grams.
(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; as sole source or organic arsenic; withdraw 5 days before slaughter; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses; Salinomycin as provided by Nos. 046573and 016592; bambermycins by No. 016592; roxarsone by No. 046573 in §510.600(c) of this chapter.
(2) Quail—(i)(a) Amount per ton. Salinomycin 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused by E. dispersa and E. lettyae.
(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.
(ii) [Reserved]
(3) Roaster and replacement (breeder and layer) chickens: It is used as follows:
(i)(A) Amount per ton. Salinomycin 40 to 60 grams.
(B) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(C) Limitations. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to horses or adult turkeys.
(ii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 4 to 50 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.
(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(iii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 50 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(iv)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.
(B) Indications for use. For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(C) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in §510.600(c).
(v) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 100 to 200 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
(B) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 046573; bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.
(vi)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 grams.
(B) Indications for use. For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(C) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Discontinue use prior to sexual maturity. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573; bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in §510.600(c).
(vii) Amount per ton. Salinomycin, 40 to 60 grams; and roxarsone, 22.7 to 45.4 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella,E. necatrix,E. acervulina,E. brunetti,E. mivati, andE. maxima, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. May be fatal if fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 046573 and roxarsone as provided by No. 046573 in §510.600(c) of this chapter.
(4) Chickens: It is used in chicken feed as follows:
(i) Amount per ton. Salinomycin, 40 to 60 grams; plus oxytetracycline, 500 grams.
(a) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for reduction of mortality due to air sacculitis (air-sac-infection) caused by Escherichia coli susceptible to oxytetracycline.
(b) Limitations. Feed continuously for 5 days; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter. Salinomycin as provided by Nos. 046573 and 016592; oxytetracycline as provided by No. 066104 in §510.600(c) of this chapter.
(ii) [Reserved]
[48 FR 30616, July 5, 1983]
Editorial Note: For Federal Register citations affecting §558.550, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.555 Semduramicin.
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(a) Specifications. Type A medicated article containing 22.7 grams per pound (50 grams per kilogram) semduramicin sodium.
(b) Approvals. See No. 066104 in §510.600(c) of this chapter for use as in paragraph (d) of this section.
(c) Related tolerances. See §556.597 of this chapter.
(d) Conditions of use in chickens. It is used in chicken feed as follows:
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------------------------------------------------------------------------ Semduramicin Combinations in grams per in grams per Indications Limitations Sponsor ton ton for use------------------------------------------------------------------------(1) 22.7 (25 ............. Broiler Do not feed to 066104 ppm) chickens: laying hens. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/ E. mitis, E. necatrix, and E. tenella.------------------------------------------------------------------------(2) 22.7 Bacitracin Broiler Feed 066104 methylene chickens: continuously disalicylate As in as sole 10 to 50 paragraph ration. Do (d)(1) of not feed to this laying hens. section; Bacitracin for methylene improved disalicylate feed as provided efficiency. by No. 046573 in § 510.600(c) of this chapter.------------------------------------------------------------------------(3) 22.7 Bacitracin Broiler Feed 066104 methylene chickens: continuously disalicylate As in as sole 10 to 50 paragraph ration. Use plus (d)(4) of feed within 2 roxarsone this weeks of 45.4 section; production. for Do not feed improved to laying feed hens. Use as efficiency. sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.------------------------------------------------------------------------(4) 22.7 Roxarsone Broiler Feed 066104 45.4 chickens: continuously For the as sole prevention ration. For of broiler coccidiosis chickens caused by only. Do not Eimeria feed to acervulina, laying hens. E. Use as sole brunetti, source of E. maxima, organic E. mivati/ arsenic. E. mitis, Withdraw 5 E. days before necatrix, slaughter. and E. Roxarsone as tenella, provided by including No. 046573 in some field § strains of 510.600(c) of E. tenella this chapter. that are more susceptible to semduramici n combined with roxarsone than semduramici n alone.------------------------------------------------------------------------(5) 22.7 Virginiamycin Broiler Feed 066104 5 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided increased by No. 066104 rate of in § weight gain 510.600(c) of and this chapter. improved feed efficiency.------------------------------------------------------------------------(6) 22.7 Virginiamycin Broiler Feed 066104 5 to 15 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided increased by No. 066104 rate of in § weight 510.600(c) of gain. this chapter.------------------------------------------------------------------------(7) 22.7 Virginiamycin Broiler Feed 066104 20 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided prevention by No. 066104 of necrotic in § enteritis 510.600(c) of caused by this chapter. Clostridium perfringens susceptible to virginiamyc in.------------------------------------------------------------------------(8) 22.7 Virginiamycin Broiler Feed 066104 20 plus chickens: continuously roxarsone As in as sole 22.7 to 45.4 paragraph ration (d)(1) of throughout this growing section; period. Do for not feed to prevention laying hens. of necrotic Use as sole enteritis source of caused by organic Clostridium arsenic. perfringens Poultry susceptible should have to access to virginiamyc drinking in; for water at all increased times. Drug rate of overdose or weight gain lack of water and may result in improved leg weakness. feed Roxarsone as efficiency; in § and for 558.530(b)(1) improved of this pigmentatio chapter n. provided by No. 046573 in § 510.600(c) of this chapter; semduramicin and virginiamycin as provided by No. 066104.------------------------------------------------------------------------
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[59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July 21, 2005]
§ 558.575 Sulfadimethoxine, ormetoprim.
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(a) Approvals. Type A medicated articles to sponsors as identified in §510.600(c) of this chapter for uses as in paragraph (d) of this section as follows:
(1) 25 percent sufadimethoxine and 15 percent ormetoprim to 046573 for use for poultry as in paragraphs (d)(1), (d)(2), (d)(3), (d)(4), and (d)(7) of this section.
(2) 25 percent sulfadimethoxine and 5 percent ormetoprim to No. 015331 for use for fish as in paragraphs (d)(5) and (d)(6) of this section.
(b) Related tolerances. See §§556.490 and 556.640 of this chapter.
(c) [Reserved]
(d) Conditions -of use. It is used in feeds for animals as follows:
(1) Broiler chickens—(i) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).
(a) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).
(b) Limitations. Feed as sole ration; withdraw 5 days before slaughter.
(ii) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent) plus roxarsone, 22.7 grams (0.0025 percent).
(a) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli, (colibacillosis); and P. multocida (fowl cholera); growth promotion and feed efficiency; improving pigmentation.
(b) Limitations. Withdraw 5 days before slaughter; as sole source of organic arsenic.
(2) Replacement chickens—(i) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).
(ii) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. galmaxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).
(iii) Limitations. Feed as a sole ration; do not feed to chickens over 16 weeks (112 days) of age; withdraw 5 days before slaughter.
(3) Turkeys—(i) Amount per ton. Sulfadimethoxine, 56.75 grams (0.00625 percent) plus ormetoprim, 34.05 grams (0.00375 percent).
(ii) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to turkeys, namely, E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial infection due to P. multocida (fowl cholera).
(iii) Limitations. Do not feed to turkeys producing eggs for food; withdraw 5 days before slaughter.
(4) Ducks—(i) Amount per ton. Sulfadimethoxine, 227 grams (0.025 percent) plus ormetoprim, 136.2 grams (0.015 percent).
(a) Indications for use. As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks, including breeding ducks.
(b) Limitations. Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; do not feed to ducks producing eggs for food.
(ii) Amount per ton. Sulfadimethoxine, 454 grams (0.05 percent) plus ormetoprim, 272.4 grams (0.03 percent).
(a) Indications for use. As an aid in the control of bacterial infections due to E. coli, Riemerella anatipestifer, and severe challenge of P. multocida (fowl cholera) in ducks.
(b) Limitations. Feed as a sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.
(5) Salmonids—(i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.
(ii) Indications of use. For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.
(iii) Limitations. Administer for 5 consecutive days; withdraw 42 days before release as stocker fish or slaughter.
(6) Catfish—(i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.
(ii) Indications for use. For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.
(iii) Limitations. Administer for 5 consecutive days; withdraw 3 days before slaughter or release as stocker fish.
(7) Chukar partridges—(i) Amount per ton. Sulfadimethoxine 113.5 grams (0.0125 percent) plus ormetoprim 68.1 grams (0.0075 percent).
(ii) Indications for use. For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.
(iii) Limitations. Feed continuously to young birds up to 8 weeks of age as sole ration.
[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005]
§ 558.579 Sulfaethoxypyridazine.
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(a) Approvals. Type A medicated articles: 5.5 percent for swine, and 5.5 and 11 percent for cattle to 010042 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.650 of this chapter.
(c) Conditions of use. It is used in animal feed as follows:
(1) Swine—(i) Amount. 25 milligrams per pound body weight per day.
(ii) Indications for use. For treatment of bacterial scours, pneumonia, enteritis, bronchitis, septicemia accompanying Salmonella choleraesuis infection.
(iii) Limitations. Administer 1,000 grams per ton (0.11 percent) for not less than 4 days nor more than 10 days; do not treat within 10 days of slaughter; as sole source of sulfonamide; for use by or on the order of a licensed veterinarian.
(2) Cattle—(i) Amount. 25 milligrams per pound body weight per day.
(ii) Indications for use. For treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis.
(iii) Limitations. Administer as a top dressing or in mixed feed for 4 days; do not treat within 16 days of slaughter; as sole source of sulfonamide; milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food; for use by or on the order of a licensed veterinarian.
[41 FR 11005, Mar. 15, 1976, as amended at 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987]
§ 558.582 Sulfamerazine.
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(a) Approvals. Type A medicated articles: 99 percent to 046573 in §510.600(c) of this chapter.
(b) Related tolerances. See §556.660 of this chapter.
(c) Conditions of use. It is used in fish feed for rainbow trout, brook trout, and brown trout as follows:
(1) Amount. 10 grams of sulfamerazine per 100 pounds of fish per day.
(2) Indications for use. Control of furunculosis.
(3) Limitations. Treat for not more than 14 days; do not treat within 3 weeks of marketing or stocking in stream open to fishing.
[41 FR 11005, Mar. 15, 1976, as amended at 51 FR 7400, Mar. 3, 1986; 61 FR 18082, Apr. 24, 1996; 63 FR 27846, May 21, 1998; 66 FR 46707, Sept. 7, 2001]
§ 558.586 Sulfaquinoxaline.
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(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.
(b) Approvals. See No. 059130 in §510.600(c) of this chapter.
(c) Special considerations. (1) For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Medicated chickens, turkeys, and rabbits must actually consume enough medicated feed which provides a recommended dose of approximately 3.5 to 60 milligrams per pound per day in chickens, 2.5 to 100 milligrams per pound per day in turkeys, and 2.8 to 68 milligrams per pound per day in rabbits depending upon age and class of animal, ambient temperature, and other factors. Consult a veterinarian or poultry pathologist for diagnosis.
(2) [Reserved]
(d) Conditions of use. It is used as follows:
(1) Chickens—(i) Amount. 0.015 percent.
(a) Indications for use. As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti under average conditions of exposure.
(b) Limitations. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.
(ii) Amount. 0.0175 percent.
(a) Indications for use. As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti where excessive exposure to coccidia is increased due to overcrowding or other management factors.
(b) Limitations. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.
(iii) Amount. 0.1 to 0.05 percent.
(a) Indications for use. As an aid in controlling outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti.
(b) Limitations. Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.
(2) Turkeys—(i) Amount. 0.0175 percent.
(a) Indications for use. As an aid in preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.
(b) Limitations. Feed 0.0175 percent continuously during time birds are closely confined. May be continued for week to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption.
(ii) Amount. 0.05 percent.
(a) Indications for use. As an aid in controlling outbreaks of coccidiosis caused by Eimeria meleagrimitis, and E. adenoeides.
(b) Limitations. Feed 0.05 percent for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary till all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption.
(3) Chickens and turkeys—(i) Amount. 0.05 or 0.1 percent.
(a) Indications for use. As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline.
(b) Limitations. Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption.
(ii) [Reserved]
(4) Rabbits—(i) Amount. 0.025 percent.
$(a) Indications for use. As an aid in preventing coccidiosis caused by Eimeria stiedae.
$(b) Limitations. Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter.
(ii) Amount. 0.1 percent.
(a) Indications for use. As an aid in controlling outbreaks of coccidiosis caused by Eimeria stiedae.
$(b) Limitations. Feed for 2 weeks. Do not treat within 10 days of slaughter.
[48 FR 3965, Jan. 28, 1983, as amended at 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 29843, July 23, 1990; 59 FR 33197, June 28, 1994; 69 FR 60547, Oct. 12, 2004]
§ 558.600 Tiamulin.
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(a) Specifications. Type A article containing 5, 10, or 113.4 grams of tiamulin (as tiamulin hydrogen fumarate) per pound.
(b) Approvals. See No. 058198 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.738 of this chapter.
(d) Special considerations—(1) Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.
(2) Not for use in swine weighing over 250 pounds.
(3) Use as sole source of tiamulin.
(e) Conditions of use—(1) Swine. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Combination in grams Tiamulin in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10........................... .................... For increased rate of Feed continuously 058198 weight gain and as the sole ration. improved feed efficiency.(ii) 35.......................... .................... 1. For control of swine Feed continuously 058198 dysentery associated as sole ration on with Brachyspira premises with a (formerly Serpulina or history of swine Treponema) dysentery but hyodysenteriae where signs of susceptible to disease have not tiamulin. yet occurred or following approved treatment of disease. Withdraw 2 days before slaughter. .................... 2. For control of Feed continuously 058198 porcine proliferative as the sole ration enteropathies for not less than (ileitis) associated 10 days. Withdraw with Lawsonia 2 days before intracellularis. slaughter.(iii) 35......................... Chlortetracycline, For treatment of swine Feed continuously 048164, approximately 400 bacterial enteritis as sole ration for 058198 (varying with body caused by Escherichia 14 days. Use as weight and feed coli and Salmonella only source of consumption to choleraesuis and chlortetracycline. provide 10 bacterial pneumonia Withdraw 2 days milligrams of caused by Pasteurella before slaughter. chlortetracycline multocida susceptible As per pound of body to chlortetracycline, chlortetracycline weight daily). and control of swine calcium complex, dysentery associated Type A medicated with Brachyspira articles (formerly Serpulina or containing the Treponema) equivalent of 50 hyodysenteriae to 100 grams per susceptible to pound of tiamulin. chlortetracycline hydrochloride provided by 046573 and 048164 in § 510.600(c) of this chapter.(iv) 200......................... .................... For treatment of swine Feed continuously 058198 dysentery associated as the sole feed with Brachyspira for 14 consecutive (formerly Serpulina or days. Withdraw Treponema) feed 7 days before hyodysenteriae slaughter. susceptible to tiamulin.----------------------------------------------------------------------------------------------------------------
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(2) [Reserved]
[67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, 2005]
§ 558.615 Thiabendazole.
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(a) Approvals. Dry Type A medicated articles: 22, 44.1, 66.1, and 88.2 percent to 050604 in §510.600(c) of this chapter. The 66.1 percent Type A is solely for the manufacture of cane molasses liquid Type B feed which is mixed in dry feeds. The 88.2 percent Type A is used solely for the manufacture of an aqueous slurry for adding to a Type C dry cattle feed.
(b) Special considerations. Do not use in Type B or Type C medicated feed containing bentonite.
(c) Related tolerances. See §556.730 of this chapter.
(d) Conditions of use. It is used in feed for animals as follows:
(1) Cattle—(i) Amount. 3 grams per 100 lb. body weight.
(a) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum).
(b) Limitations. Use 3 grams per 100 lb. body weight at a single dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.
(ii) Amount. 5 grams per 100 lb. body weight.
(a) Indications for use. Control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum); control of infections of Cooperia spp.
(b) Limitations. 5 grams per 100 lb. body weight at a single dose or divided into 3 equal doses, administered 1 dose each day, on succeeding days; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.
(2) Goats—(i) Amount. 3 grams per 100 lb. body weight.
(ii) Indications for use. Control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ).
(iii) Limitations. 3 grams per 100 lb. body weight at a single dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.
(3) Sheep and goats—(i) Amount. 2 grams per 100 lb. body weight.
(ii) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp.; Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also active against ova and larvae passed by sheep from 3 hours to 3 days after the feed is consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia spp., Nematodirus spp., Strongyloides spp.; less effective against those of Haemonchus contortus and Oesophagostomum spp. ).
(iii) Limitations. Use 2 grams per 100 lb. body weight at a single dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.
(4) For swine—(i) Amount. 45.4–908 grams per ton (0.005–0.1 percent).
(ii) Indications for use. Aid in the prevention of infections of large roundworms (genus Ascaris).
(iii) Limitations. Administer continuously feed containing 0.05–0.1 percent thiabendazole per ton for 2 weeks followed by feed containing 0.005–0.02 percent thiabendazole per ton for 8–14 weeks; do not treat animals within 30 days of slaughter.
(5) Pheasants—(i) Amount. 454 grams per ton (0.05 percent) continuously for 2 weeks (14 days).
(ii) Indications for use. For the treatment of gapeworms (Syngamus trachea) in pheasants.
(iii) Limitations. Do not use treated pheasants for food for 21 days after last day of treatment. Fertility, hatchability, and other reproductive data are not available on use in breeding animals.
[40 FR 13959, Mar. 27, 1975, as amended at 47 FR 49641, Nov. 2, 1982; 49 FR 29958, July 25, 1984; 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 62 FR 63271, Nov. 28, 1997]
§ 558.618 Tilmicosin.
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(a) Specifications. Type A medicated article containing 20 percent tilmicosin as tilmicosin phosphate (90.7 grams per pound).
(b) Approvals. See No. 000986 in §510.600(c) of this chapter.
(c) Special considerations. (1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See §558.6 of this chapter for additional requirements for the use of products regulated as veterinary feed directives (VFDs).
(2) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance. VFDs for tilmicosin shall not be refilled.
(3) Do not use in Type B or Type C medicated feeds containing bentonite.
(d) Related tolerances. See §556.735 of this chapter.
(e) Conditions of use. It is used in swine feed as follows:
(1) Amount per ton. 181 grams to 363 grams tilmicosin.
(2) Indications for use. For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
(3) Limitations. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an expected disease outbreak. Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an appropriate antimicrobial. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Do not allow horses or other equines access to feeds containing tilmicosin. Withdraw 7 days before slaughter.
[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 2002; 69 FR 78306, Dec. 30, 2004]
§ 558.625 Tylosin.
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(a) Specifications. Tylosin is the antibiotic substance produced by growth of Streptomyces fradiae or the same antibiotic substance produced by any other means. Tylosin, present as the phosphate salt, conforms to the appropriate antibiotic standard. Tylosin contains at least 95 percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and tylosin D of which at least 80 percent is tylosin A as determined by a method entitled “Determination of Factor Content in Tylosin by High Performance Liquid Chromatography,” which is incorporated by reference. Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php.
(b) Approvals. Type A medicated article levels of tylosin granted to firms as sponsor(s) and identified by drug listing numbers in §510.600(c) of this chapter for the specific usage indicated in paragraph (f) of this section.
(1) To 000986: 10, 40, 100 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(2) [Reserved]
(3) To 043733: 20 and 40 grams per pound, paragraphs (f)(1)(i) through (vi) of this section.
(4) [Reserved]
(5) To No. 051311: 0.4, 0.8, 1, and 8 grams per pound, paragraph (f)(1)(vi)(a) of this section; 10 and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(6)–(7) [Reserved]
(8) To 035369: 4 and 10 grams per pound, paragraph (f)(1)(vi)(a) of this section; 10 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(9) [Reserved]
(10) To 017519: 0.4, 0.8, and 1.6 grams per pound, paragraph (f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, paragraphs (f)(1)(i) through (f)(1)(vi) of this section.
(11) [Reserved]
(12) To 021930: 2 grams per pound, paragraph (f)(1)(vi)(a) of this section; 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(13) [Reserved]
(14) To 016968: 1, 2, 4, 8, and 10 grams per pound, paragraphs (f)(1) (i), (iii), (iv), and (vi) of this section; 20, 25, 40, and 100 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(15)–(24) [Reserved]
(25) To 066104: 4, 8, and 10 grams per pound, paragraph (f)(1)(vi)(a) of this section; 20 and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(26)–(32) [Reserved]
(33) To 034936: 0.8 and 2 grams per pound, paragraph (f)(1)(vi)(a) of this section; 4, 8, and 10 grams per pound, paragraphs (f)(1)(i), (iii), (iv), and (vi) of this section; 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section; 100 grams per pound, paragraphs (f)(1) (i), (ii), (iii), (iv), and (vi) of this section.
(34) [Reserved]
(35) To 039741: 2 and 10 grams per pound, paragraph (f)(1)(vi)(a) of this section.
(36)–(37) [Reserved]
(38) To 053740: 1 gram per pound, paragraph (f)(1)(vi)(a) of this section; 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(39) To 061623: 10 grams per pound, paragraph (f)(1)(vi)(a) of this section.
(40) To 035955: 10 grams per pound, paragraph (f)(1)(vi)(a) of this section.
(41) [Reserved]
(42) To 010439: 0.4, 0.5, and 2 grams per pound, paragraph (f)(1)(vi) (a) of this section; 5, 10, 20, and 40 grams per pound, paragraph (f)(1)(i) through (vi) of this section.
(43)–(44) [Reserved]
(45) To 017139: 4 and 10 grams per pound, paragraph (f)(1)(vi)(a) of this section.
(46)–(47) [Reserved]
(48) To 017790: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(49)–(53) [Reserved]
(54) To 046573: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(55)–(56) [Reserved]
(57) To 028459: 0.4 and 10 grams per pound; paragraph (f)(1)(vi)(a) of this section.
(58)–(62) [Reserved]
(63) To 046987: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(64)–(65) [Reserved]
(66) To 024174: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(67) To 027190: 2 grams per pound; paragraph (f)(1)(vi)(a) of this section.
(68) To 017473: 10 and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(69)–(76) [Reserved]
(77) To 050639: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(78) To 050972: 0.36, 0.4, 0.72, and 0.8 gram per pound, paragraph (f)(1)(vi)(a) of this section; 1 gram per pound, paragraphs (f)(1)(vi) (a), (b), and (d) of this section.
(79) [Reserved]
(80) To 049685: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(81)–(82) [Reserved]
(83) To 046573: 5-, 10-, 20-, and 40-grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(84) [Reserved]
(85) To 047126: 10, 40, and 100 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
(86)–(88) [Reserved]
(89) To 048164: 5, 10, 20, and 40 grams per pound, paragraph (f)(1) (i) through (vi) of this section.
(c) Special considerations. (1) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) Tylosin liquid Type B medicated feeds used to make Type C medicated feeds for cattle may be manufactured from tylosin Type A medicated articles according to the following mixing directions:
(i) Presolubilize tylosin in 50 percent urea for approximately 1 hour prior to adding any feed components or other active ingredients.
(ii) Maintain a pH between 4.5 and 6.0.
(3) Tylosin liquid Type B medicated feeds must bear an expiration date of 8 weeks after the date of manufacture.
(d) [Reserved]
(e) Related tolerances. See §556.740 of this chapter.
(f) Conditions of use. (1) It is used in animal feeds as follows:
(i) For beef cattle—(a) Amount per ton. 8–10 grams.
(b) Indications for use. For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.
(c) Limitations. As tylosin phosphate; each animal must receive not more than 90 milligrams per day and not less than 60 milligrams per day; feed continuously as sole ration.
(ii) Broiler chickens—(a) Amount per ton. Tylosin, 800–1000 grams.
(b) Indications for use. To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.
(c) Limitations. As tylosin phosphate; withdraw 5 days before slaughter; administer in feed to chickens 0 to 5 days of age, follow with second administration in feed for 24–48 hours at 3 to 5 weeks of age.
(iii) Chickens—(a) Amount per ton. Tylosin, 4–50 grams.
(1) Indications for use. For increased rate of weight gain and improved feed efficiency.
(2) Limitations. As tylosin phosphate.
(iv) Laying chickens—(a) Amount per ton. Tylosin, 20–50 grams.
(b) Indications for use. For improved feed efficiency.
(c) Limitations. As tylosin phosphate.
(v) Replacement chickens—(a) Amount per ton. Tylosin, 1,000 grams.
(b) Indications for use. To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.
(c) Limitations. As tylosin phosphate; withdraw 5 days before slaughter; administer in feed to chickens 0 to 5 days of age, follow with second administration in feed for 24 to 48 hours at 3 to 5 weeks of age.
(vi) Swine—(a) Amount per ton. Tylosin, 10–100 grams.
(1) Indications for use. For increased rate of weight gain and improved feed efficiency.
(2) Limitations. As tylosin phosphate; continuous use as follows: Grams per ton: 20–100, prestarter or starter; 20–40, grower; 10–20, finisher.
(b) Amount per ton. Tylosin, 40–100 grams.
(1) Indications for use. Prevention of swine dysentery (vibrionic).
(2) Limitations. Use 100 grams per ton for at least 3 weeks followed by 40 grams per ton until market weight; as tylosin phosphate.
(c) Amount per ton. Tylosin, 40–100 grams.
(1) Indications for use. Treatment and control of swine dysentery (vibrionic).
(2) Limitations. Administer in feed as tylosin phosphate after treatment with tylosin in drinking water as tylosin base; 0.25 gram per gallon in drinking water for 3–10 days, 40–100 grams per ton in feed for 2–6 weeks.
(d) Amount per ton. Tylosin, 100 grams.
(1) Indications for use. Maintaining weight gains and feed efficiency in presence of atrophic rhinitis.
(2) Limitations. As tylosin phosphate.
(vi) Pyrantel tartrate in accordance with §558.485.
(e) Amount per ton. Tylosin 100 grams.
(1) Indications for use. Prevention and/or control of procine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.
(2) Limitations. As tylosin phosphate, administer for 21 days.
(2) Tylosin may also be used in combination with:
(i) Decoquinate and monensin as in §558.195.
(ii) Hygromycin B as in §558.274.
(iii) Melengestrol acetate alone or in combination with certain ionophores as in §558.342.
(iv) Monensin as in §558.355.
(v) Narasin as in §558.363.
(vi) Pyrantel tartrate as in §558.485.
(vii) Ractopamine alone or in combination as in §558.500.
(viii) Salinomycin as in §558.550.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.625, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.630 Tylosin and sulfamethazine.
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(a) [Reserved]
(b) Approvals. Type A medicated article levels, a combination of equal amounts of tylosin and sulfamethazine, granted to firms as sponsor(s) and identified by drug listing numbers in §510.600(c) of this chapter for the conditions of use indicated in paragraph (f) of this section.
(1) To 000986: 40 grams per pound each, paragraph (f)(2)(i).
(2) To 000986: 10 grams per pound each, paragraph (f)(2)(i).
(3) To 017519: 10 grams per pound each, paragraph (f)(2)(ii) of this section.
(4) [Reserved]
(5) To No. 051311: 40 grams per pound each, paragraph (f)(2)(ii) of this section.
(6) To 017139: 4, 10, or 20 grams per pound each, paragraph (f)(2)(ii) of this section.
(7) To 021930: 2 grams per pound each, paragraph (f)(2)(i) of this section; 5, 10, 20, or 40 grams per pound each, paragraph (f)(2)(ii) of this section.
(8) To 017519: 5 or 10 grams per pound each, paragraph (f)(2)(ii) of this section.
(9) [Reserved]
(10) To 000986, 010439, 011749, 016968, 017473, 017519, 024174, 030841, 034936, 035098, 043733, 046573, 046987, 048164, and 051359: 5, 10, 20, or 40 grams per pound each, paragraph (f)(2)(ii) of this section.
(c)–(d) [Reserved]
(e) Related tolerances. See §§556.670 and 556.740 of this chapter.
(f) Conditions of use. It is used in feed for swine as follows:
(1) Amount per ton. Tylosin, 100 grams plus sulfamethazine, 100 grams.
(2) Indications for use. (i) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (P. multocida and/or C. pyogenes); for reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.
(ii) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes).
(3) Limitations. As tylosin phosphate; withdraw 15 days before slaughter.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.630, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.635 Virginiamycin.
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(a) Approvals. Type A medicated articles. (1) 1.1 percent activity (5 grams per pound), 2.2 percent activity (10 grams per pound), 4.4 percent activity (20 grams per pound), 11 percent activity (50 grams per pound), and 50 percent activity (227 grams per pound) used as in paragraph (d) of this section; and 30 percent activity (136.2 grams per pound) for the manufacture of Type C medicated feed for cattle used as in paragraph (d)(3); to 066104 in §510.600(c) of this chapter.
(2) 2.2 percent activity (10 grams per pound) to 046573, 016968, and 017790 in §510.600(c) of this chapter for use as in paragraphs (d)(1)(iv) and (d)(1)(v) of this section.
(b) Related tolerances. See §556.750 of this chapter.
(c) Special considerations. (1) Not for use in breeding swine over 120 pounds.
(2) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.
(d) Conditions of use—(1) Swine. It is used as follows:
(i) 100 grams per ton for 2 weeks, for treatment of swine dysentery in nonbreeding swine over 120 pounds.
(ii) 100 grams per ton for 2 weeks, 50 grams per ton thereafter, for treatment and control of swine dysentery in swine up to 120 pounds.
(iii) 25 grams per ton, as an aid in control of dysentery in swine up to 120 pounds. For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred.
(iv) 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 grams per ton to market weight for increased rate of weight gain and improved feed efficiency. For continuous use from weaning to market weight.
(v) 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 to 10 grams per ton to market weight for increased rate of weight gain. For continuous use from weaning to market weight.
(2) Poultry. It is used as follows:
(i) 5 to 15 grams per ton for increased rate of weight gain, for use in broiler chickens, not for use in layers.
(ii) 5 grams per ton for increased rate of weight gain and improved feed efficiency in broiler chickens, not for use in layers.
(iii) 20 grams per ton for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin in broiler chickens; not for use in layers.
(iv) 10 to 20 grams per ton for increased rate of weight gain and improved feed efficiency in growing turkeys.
(3) Cattle. It is used as follows:
(i) 16.0 to 22.5 grams per ton to provide 100 to 340 milligrams per head per day for increased rate of weight gain.
(ii) 13.5 to 16.0 grams per ton to provide 85 to 240 milligrams per head per day for reduction of incidence of liver abscesses.
(iii) 11.0 to 16.0 grams per ton to provide 70 to 240 milligrams per head per day for improved feed efficiency.
(iv) Feed continuously as sole ration to cattle fed in confinement for slaughter. Not for use in animals intended for breeding.
(4) Virginiamycin may be used in combination with:
(i) Amprolium and ethopabate as in §558.58.
(ii) Diclazuril as in §558.198.
(iii) Halofuginone as in §558.265.
(iv) Lasalocid as in §558.311.
(v) Monensin alone or with roxarsone as in §558.355.
(vi) Salinomycin alone or with roxarsone as in §558.550.
(vii) Semduramicin alone or with roxarsone as in §558.555.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting §558.635, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 558.680 Zoalene.
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(a) Specifications. Type A medicated article containing 25 percent zoalene.
(b) Approvals. See No. 046573 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.770 of this chapter.
(d) Conditions of use—(1) Chickens and turkeys:
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---------------------------------------------------------------------------------------------------------------- Combination in grams/ Zoalene in grams/ton ton Indications for use Limitations----------------------------------------------------------------------------------------------------------------(i) 36.3-113.5 (0.004-0.0125%)....... ....................... Replacement chickens; Grower ration not to be development of active fed to birds over 14 immunity to weeks of age; as coccidiosis.. follows:----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Growing conditions Starter ration Grower ration Grams per ton Grams per ton ---------------------------------------------------------------- Severe exposure 113.5 (0.0125%) 75.4-113.5 (0.0083%-0.0125%) Light to moderate 75.4-113.5 36.3-75.4 (0.004%- exposure (0.0083%-0.0125%) 0.0083%) ----------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Zoalene in grams/ton ton Indications for use Limitations---------------------------------------------------------------------------------------------------------------- Arsanilate sodium 90 Replacement chickens; Grower ration not to be (0.01%).. development of active fed to birds over 14 immunity to weeks of age; withdraw coccidiosis; growth 5 days (d) before promotion and feed slaughter; as sole efficiency; improving source of organic pigmentation.. arsenic; feed as in subtable in item (i). Arsanilic acid 90 Replacement chickens; Grower ration not to be (0.01%).. development of active fed to birds over 14 immunity to weeks of age; withdraw coccidiosis; growth 5 d before slaughter; promotion and feed as sole source of efficiency; improving organic arsenic; feed pigmentation.. as in subtable in item (i). Arsanilic acid 90 Replacement chickens; As erythromycin (0.01%) plus growth promotion and thiocyanate; grower erythromycin 4.6 to feed efficiency; ration not to be fed 18.5.. development of active to birds over 14 weeks immunity to of age; withdraw 5 d coccidiosis; improving before slaughter; as pigmentation.. sole source of organic arsenic; feed as in subtable item (i). Arsanilic acid 90 1. Replacement Feed for 2 d before (0.01%) plus chickens; as an aid in stress and 3 to 6 d erythromycin 92.5.. the prevention of after stress; as chronic respiratory erythromycin disease during periods thiocyanate; grower of stress; development ration not to be fed of active immunity to to birds over 14 weeks coccidiosis; growth of age; withdraw 5 d promotion and feed before slaughter; as efficiency; improving sole source of organic pigmentation.. arsenic arsenic; feed as in subtable in item (i). ....................... 2. Replacement Feed for 7 to 14 d; as chickens; as an aid in erythromycin the prevention of thiocyanate; grower infectious coryza; ration not to be fed development of active to birds over 14 weeks immunity to of age; withdraw 5 d coccidiosis; growth before slaughter; as promotion and feed sole source of organic efficiency; improving arsenic; feed as in pigmentation.. subtable in item (i). Arsanilic acid 90 Replacement chickens; Feed for 5 to 8 d; do (0.01%) plus as an aid in the not use in birds erythromycin 185.. prevention and producing eggs for reduction of lesions food purposes; and in lowering withdraw 5 d before severity of chronic slaughter; as respiratory disease; erythromycin growth promotion and thiocyanate; as sole feed efficiency; source of organic improving pigmentation arsenic; feed as in and development of subtable in item (i). active immunity to coccidiosis.. Arsanilic acid 90 Replacement chickens; As procaine penicillin; (0.01%) plus growth promotion and grower ration not to penicillin 2.4 to 50.. feed efficiency; be fed to birds over development of active 14 weeks of age; immunity to withdraw 5 d before coccidiosis; improving slaughter; as sole pigmentation.. source of organic arsenic; feed as in subtable in item (i). Bacitracin 4 to 50..... Replacement chickens: Feed as in subtable in For development of § active immunity to 558.680(d)(1)(i); coccidiosis; for grower ration not to increased rate of be fed to birds over weight gain, improved 14 weeks of age. As feed efficiency. bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter. Bacitracin methylene Replacement chickens: Feed as in subtable in disalicylate 4 to 50 For development of § plus roxarsone 22.7 to active immunity to 558.680(d)(1)(i); 45.4. coccidiosis; for grower ration not to increased rate of be fed to birds over weight gain, improved 14 weeks of age. feed efficiency, and Discontinue use 5 days improved pigmentation. before slaughter; as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. As bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter. Bacitracin methylene... Replacement chickens; Feed continuously as disalicylate 50....... development of active sole ration as in immunity to subtable in this item coccidiosis; as an aid (i); grower ration not in the prevention of to be fed to birds necrotic enteritis over 14 weeks of age. caused or complicated Bacitracin methylene by Clostridium spp. or disalicylate as other organisms provided by 046573 in susceptible to § 510.600(c) of bacitracin.. this chapter. Bacitracin methylene Replacement chickens; Feed continuously as disalicylate 100 to development of active sole ration as in 200. immunity to subtable in this item coccidiosis; as an aid (i). To control in the control of necrotic enteritis, necrotic enteritis start medication at caused or complicated first clinical signs by Clostridium spp. or of disease; vary other organisms bacitracin dosage susceptible to based on the severity bacitracin.. of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams/ton). Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter. Bacitracin 100 to 500.. Replacement chickens; As bacitracin zinc; treatment of chronic grower ration not to respiratory disease be fed to birds over (air-sac infection); 14 weeks of age; feed blue comb (nonspecific as in subtable in item infectious enteritis); (i). development of active immunity to coccidiosis.. Chlortetracycline 100 Replacement chickens; Do not feed to chickens to 200.. development of active producing eggs for immunity to human consumption; coccidiosis; control grower ration not to of infectious be fed to birds over synovitis caused by 14 weeks of age; feed Mycoplasma synoviae as in subtable in item susceptible to (i). chlortetracycline.. Chlortetracycline 200 Replacement chickens; Do not feed to chickens to 400.. development of active producing eggs for immunity to human consumption; coccidiosis; control grower ration not to of chronic respiratory be fed to birds over disease (CRD) and air 14 weeks of age; feed sac infection caused as in subtable in item by M. gallisepticum (i). and Escherichia coli susceptible to chlortetracycline.. Erythromycin 4.6 to Replacement chickens; As erythromycin 18.5.. growth promotion and thiocyanate; grower feed efficiency; ration not to be fed development of active to birds over 14 weeks immunity to of age; feed as in coccidiosis.. subtable in item (i). Erythromycin 92.5...... 1. Replacement Feed for 2 d before chickens, as an aid in stress and 3 to 6 the prevention of after stress; withdraw chronic respiratory 24 hours (h) before disease during periods slaughter; as of stress; development erythromycin of active immunity to thiocyanate; grower coccidiosis.. ration not to be fed to birds over 14 weeks of age; feed as in subtable in item (i). ....................... 2. Replacement Feed for 7 to 14 d; chickens; as an aid in withdraw 24 h before the prevention of slaughter; as infectious coryza; erythromycin development of active thiocyanate; grower immunity to ration not to be fed coccidiosis.. to birds over 14 weeks of age; feed as in subtable in item (i). Erythromycin 185....... Replacement chickens; Feed for 5 to 8 d; do as an aid in the not use in birds prevention and producing eggs for reduction of lesions food purposes; and in lowering withdraw 48 h before severity of chronic slaughter; grower respiratory disease; ration not to be fed development of active to birds over 14 weeks immunity to of age; feed as in coccidiosis.. subtable in item (i). Hygromycin B 8 to 12... Replacement chickens; Grower ration not to be development of active fed to birds over 14 immunity to weeks of age; feed as coccidiosis; control in subtable in item of infestation of (i). large round worms (Ascaris galli) cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignate).. Penicillin 2.4 to 50... Replacement chickens; As procaine penicillin; growth promotion and grower ration not to feed efficiency; be fed to birds over development of active 14 weeks of age; feed immunity to as in subtable in item coccidiosis.. (i). Penicillin 2.4 to 50 Replacement chickens; As procaine penicillin; plus roxarsone 22.7 to growth promotion and grower ration not to 45.4 (0.0025% to feed efficiency; be fed to birds over 0.005%).. development of active 14 weeks of age; immunity to withdraw 5 d before coccidiosis; improving slaughter; as sole pigmentation.. source of organic arsenic; feed as in subtable in item (i). Roxarsone 22.7 to 45.5 Replacement chickens; Grower ration not to be (0.0025% to 0.005%).. development of active fed to birds over 14 immunity to weeks of age; withdraw coccidiosis; growth 5 d before slaughter; promotion and feed as sole source of efficiency; improving organic arsenic; feed pigmentation.. as in subtable in item (i).(ii) 113.5 (0.0125%)................. ....................... Broiler chickens; prevention and control of coccidiosis.. Arsanilate sodium 90 Broiler chickens; Withdraw 5 d before (0.01%).. prevention and control slaughter; as sole of coccidiosis; growth source of organic promotion and feed arsenic. efficiency; improving pigmentation.. Arsanilic acid 90 Broiler chickens; Withdraw 5 d before (0.01%).. growth promotion and slaughter; as sole feed efficiency; source of organic prevention and control arsenic. of coccidiosis; improving pigmentation.. Arsanilic acid 90 Broiler chickens; As erythromycin (0.01%) plus growth prevention and thiocyanate; withdraw erythromycin 4.6 to control of 5 d before slaughter; 18.5.. coccidiosis; improving as sole source of pigmentation.. organic arsenic. Arsanilic acid 90 1. Broiler chickens; as Do. (0.01%) plus an aid in the erythromycin 92.5.. prevention of chronic respiratory disease during periods of stress; growth promotion and feed efficiency; improving pigmentation; control of coccidiosis.. ....................... 2. Broiler chickens; Do. prevention and control of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of infectious coryza.. Arsanilic acid 90 Broiler chickens; as an Feed for 5 to 8 d; do (0.01%) plus aid in the prevention not use in birds erythromycin 185.. and reduction of producing eggs for lesions and in food purposes; as lowering severity of erythromycin chronic respiratory thiocyanate; withdraw disease; prevention 5 d before slaughter; and control of as sole source of coccidiosis; growth organic arsenic. promotion and feed efficiency; improving pigmentation.. Arsanilic acid 90 Broiler chickens; As procaine penicillin; (0.01%) plus growth promotion and withdraw 5 d before penicillin 2.4 to 50.. feed efficiency; slaughter; as sole prevention and control source of organic of coccidiosis; arsenic. improving pigmentation.. Arsanilic acid 90 Broiler chickens; Withdraw 5 d before (0.01%) plus prevention and control slaughter; as sole bacitracin 4 to 50.. of coccidiosis; source of organic improving arsenic; as bacitracin pigmentation; growth methylene promotion and feed disalicylate. efficiency.. Bacitracin 4 to 50..... Broiler chickens; As bacitracin methylene growth promotion and disalicylate or zinc feed efficiency; bacitracin. prevention and control of coccidiosis.. Bacitracin 4 to 50 plus Broiler chickens; As bacitracin methylene roxarsone 22.7 to 45.4 growth promotion and disalicylate or zinc (0.0025 to 0.005%).. feed efficiency; bacitracin; withdraw 5 prevention and control d before slaughter; as of coccidiosis; sole source of organic improving arsenic. pigmentation.. Bacitracin methylene Broiler chickens; Feed continuously as disalicylate 50. prevention and control sole ration. of coccidiosis; as an Bacitracin methylene aid in the prevention disalicylate as of necrotic enteritis provided by 046573 in caused or complicated § 510.600(c) of by Clostridium spp. or this chapter. other organisms susceptible to bacitracin.. Bacitracin methylene Broiler chickens; Feed continuously as disalicylate 100 to prevention and control sole ration. To 200. of coccidiosis; as an control necrotic aid in the control of enteritis, start necrotic enteritis medication at first caused or complicated clinical signs of by Clostridium spp. or disease; vary other organisms bacitracin dosage susceptible to based on the severity bacitracin.. of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams/ton). Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter. Bacitracin 100 to 500.. Broiler chickens; As zinc bacitrain. treatment of chronic respiratory disease (air-sac infection); blue comb (nonspecific infectious enteritis); prevention and control of coccidiosis.. Bambermycins 1......... Broiler chickens: As an Feed continuously as aid in the prevention sole ration. Do not and control of feed to chickens over coccidiosis; and for 14 weeks of age. increased rate of Bambermycins as weight gain and provided by No. 016592 improved feed in § 510.600(c) efficiency.. of this chapter. Bambermycins 1 plus Broiler chickens: As an Feed continuously as roxarsone 22.7. aid in the prevention sole ration. Do not and control of feed to chickens over coccidiosis; and for 14 weeks of age; feed increased rate of as sole source of weight gain and organic arsenic; improved feed withdraw 5 days before efficiency.. slaughter. Bambermycins as provided by No. 016592, roxarsone by No. 046573 in § 510.600(c) of this chapter. Chlortetracycline 100 Broiler chickens; Do not feed to chickens to 200. prevention and control producing eggs for of coccidiosis; human consumption; control of infectious feed continuously for synovitis caused by M. 7 to 14 d. synoviae susceptible to chlortetracycline.. Chlortetracycline 200 Broiler chickens; Do not feed to chickens to 400. prevention and control producing eggs for of coccidiosis; human consumption; control of chronic feed continuously for respiratory disease 7 to 14 d. (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline.. Erythromycin 4.6 to Broiler chickens; As erythromycin 18.5.. growth promotion and thiocyanate. feed efficiency; prevention and control of coccidiosis.. Erythromycin 92.5...... 1. Broiler chickens; as Feed for 2 d before an aid in the stress and 3 to 6 d prevention of chronic after stress; withdraw respiratory disease 24 h before slaughter; during period of as erythromycin stress; prevention and thiocyanate. control of coccidiosis.. ....................... 2. Broiler chicken; as Feed for 7 to 14 d; an aid in the withdraw 24 h before prevention of slaughter; as infectious coryza; erythromycin prevention and control thiocyanate. of coccidiosis.. Erythromycin 185....... Broiler chickens; as an Feed for 5 to 8 d; do aid in the prevention not use in birds and reduction of producing eggs for lesions and in food purposes; lowering severity of withdraw 48 h before chronic respiratory slaughter; as disease; prevention erythromycin and control of thiocyanate. coccidiosis.. Hygromycin B 8 to 12... Broiler chickens; ....................... prevention and control of coccidiosis; control of infestation of large round worms (Ascaris galli) cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignate) .. Lincomycin 2........... Broiler chickens; Do not feed to laying increase in rate of chickens; to be fed as weight gain; improved the sole ration; as feed efficiency; as an lincomycin aid in the prevention hydrochloride and control of monohydrate provided coccidiosis.. by No. 000009 in § 510.600(c) of this chapter. Penicillin 2.4 to 50... Broiler chickens; As procaine penicillin. growth promotion and feed efficiency; prevention and control of coccidiosis.. Penicillin 2.4 to 50 Broiler chickens; Withdraw 5 d before plus roxarsone 22.7 to prevention and control slaughter; as sole 45.4 (0.0025 to of coccidiosis; growth source of organic 0.005%).. promotion and feed arsenic; as procaine efficiency; improving penicillin. pigmentation.. Roxarsone 22.7 to 45.4 Broiler chickens; Withdraw 5 d before (0.0025 to 0.005%).. prevention and control slaugher; as sole of coccidiosis; growth source of organic promotion and feed arsenic. efficiency; improving pigmentation..(iii) 113.5 to 170.3 (0.0125 to ....................... Turkeys; prevention and For turkeys grown for 0.01875%).. control of meat purposes only. coccidiosis.. Arsanilate sodium 90 Turkeys; growth For turkeys grown for (0.01%).. promotion and feed meat purposes only; efficiency; improving withdraw 5 d before pigmentation.. slaughter; as sole source of organic arsenic. Arsanilic acid do.................... Do. 90(0.01%).. Bacitracin methylene Turkeys; prevention and For turkeys grown for disalicylate 4-50.. control of meat purposes only, coccidiosis, and not to be fed to increased rate of laying birds, feed weight gain and continuously as sole improved feed ration until 14 to 16 efficiency.. weeks of age. Carbarsone (not U.S.P.) Turkeys; prevention and For turkeys grown for 277 to 340.5 (0.025% control of meat purposes only; to 0.0375%).. coccidiosis; aid in feed continuously the prevention of beginning 2 weeks blackhead.. before blackhead and coccidiosis are expected and continue as long as prevention of blackhead and prevention and control of coccidiosis is needed; withdraw 5 d before slaughter; as sole source of organic arsenic. Roxarsone 22.7 to 45.4 Turkeys; growth Withdraw 5 d before (0.0025% to 0.005%).. promotion and feed slaughter; as sole efficiency; improving source of organic pigmentation.. arsenic.----------------------------------------------------------------------------------------------------------------
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(2) Zoalene may also be used in combination with roxarsone as in §558.530.
[41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR 27958, May 15, 2006]
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