21 C.F.R. Subpart A—General Provisions
Title 21 - Food and Drugs
(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] (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: (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 (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] (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] (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: (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: [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]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart A—General Provisions
§ 558.3 Definitions and general considerations applicable to this part.
§ 558.4 Requirement of a medicated feed mill license.
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.
§ 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.
---------------------------------------------------------------------------------------------------------------- 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.----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- 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).----------------------------------------------------------------------------------------------------------------
