CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART A—General Provisions (§558.3 to §558.15) > 558.4—Requirement of a medicated feed mill license.

558.4—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 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:
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.
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.
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 (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
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.
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 9.1 g/lb (2.0%) Swine feed: 85-115Catfish feed: 80-110 Salmonid feed: 80-110
Code of Federal Regulations 389
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 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.
Sulfanitran 85-115 13.6 g/lb (3.0%) 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.
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.
Aklomide 90-110 11.2 g/lb (2.5%) 85-120.
Aklomide 90-110 11.2 g/lb (2.5%) 85-120.
Roxarsone 90-110 2.715 g/lb (0.60%) 85-120.
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.
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.

Code of Federal Regulations

[51 FR 7392, Mar. 3, 1986]

Code of Federal Regulations

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.fdsys.gov.