21 Food and Drugs 6 2006-04-01 2006-04-01 false Requirement of a medicated feed mill license. 558.4 Section 558.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS General Provisions
§ 558.4 Requirement of a medicated feed mill license. Link to an amendment published at 71 FR 16221, Mar. 31, 2006.

(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 §§ 510.515 and 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 Drug Assay limits percent 1 type A Type B maximum (200x) Assay limits percent 1 type B/C 2 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, 100-108 3.5 g/lb (0.8%) 90-115. 5 and 10 g/1b, 90-115 70-130. Tylosin 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 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. 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%) 75-125 Florfenicol 90-110 n/a 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. 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%) 85-115/75-125 Nicarbazin (powder) 98-106 5.675 g/lb (1.25%) 85-115/80-120 Nitarsone 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.

(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.

 Effective Date Note:

At 71 FR 16221, Mar. 31, 2006, paragraph (c) of § 558.4 was amended by removing “§§ 510.515 and 558.15” and adding in its place“§ 558.15”, effective May 1, 2006.