21CFR558.4

(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: (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: [TABLE] 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. (e) When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product. (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.