21 C.F.R. § 558.4 Requirement of a medicated feed mill license.
Title 21 - Food and Drugs
(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
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart A—General Provisions
§ 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.
