Requirement of a medicated feed mill license.

(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. (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 Drug Assay limits percent 1 Type A Type B maximum (200x) Assay limits percent 1 Type B/C 2 Amprolium with Ethopabate 94-114 22.75 g/lb (5.0%) 80-120. Avilamycin 90-110 7.3 g/lb (1.6%) 80-110. Bacitracin methylenedisalicylate 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. 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. 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. Lubabegron 87-107 908 g/ton 85-115/80-120. 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 9.0 g/lb (1.98%) 85-115/75-125. Nicarbazin (granular) 90-110 9.0 g/lb (1.98%) 85-115/75-125. Narasin 90-110 9.0 g/lb (1.98%) 85-115/75-125. Nystatin 85-125 5.0 g/lb (1.1%) 75-125. Oxytetracycline 90-120 20.0 g/lb (4.4%) 75-125/65-135. 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 90-110 6.0 g/lb (1.3%) 80-120. Semduramicin (as semduramicin sodium) 90-110 2.27 g/lb (0.50%) 80-110 Semduramicin (as semduramicin sodium biomass) 90-110 2.27 g/lb (0.50%) 80-120 Tylosin 80-120 10.0 g/lb (2.2%) 75-125. Tylvalosin 90-110 3.86 g/lb 85-115. 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 Drug Assay limits percent 1 Type A Type B maximum (100x) Assay limits percent 1 Type B/C 2 Amprolium 94-114 11.35 g/lb (2.5%) 80-120. Apramycin 88-112 7.5 g/lb (1.65%) 80-120. Carbadox 90-110 2.5 g/lb (0.55%) 75-125. Clopidol 94-106 11.4 g/lb (2.5%) 90-115/80-120. Erythromycin 85-115 4.625 g/lb (1.02%) 75-125. Famphur 100-110 5.5 g/lb (1.21%) 90-115/80-120. Fenbendazole 93-113 8.87 g/lb (1.96%) 75-125. Florfenicol 90-110 9.1 g/lb (2.0%) Swine feed: 85-115 Catfish feed: 80-110. Salmonid feed: 80-110. Halofuginone 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. 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 20 g/lb (4.4%) 70-125. Oxytetracycline 80-120 20 g/lb (4.4%) 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. Nicarbazin (powder) 96-104 9.08 g/lb (2.00%) 85-115/80-120. 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. Sulfadimethoxine 90-110 Poultry: 5.675 g/lb Fish: 85.1 g/lb 80-115/75-125. Ormetoprim 90-110 Poultry: 3.405 g/lb Fish: 17.0 g/lb 80-115. 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. Sulfamethazine 85-115 10.0 g/lb (2.2%) 80-120. Tylosin 80-120 10.0 g/lb (2.2%) 75-125. Sulfaquinoxaline 98-106 11.2 g/lb (2.5%) 85-115. Tiamulin hydrogen fumarate 90-115 10 g/lb 90-115/70-130. Tilmicosin 90-110 37.9 g/lb (8.35%) Swine Type B/C feed: 85-115. Cattle Type B feed: 85-115. Cattle Type C feed: 80-110. Zilpaterol 90-110 680 g/t (0.075%) 80-110/75-115. 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. (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 at www.govinfo.gov.