21 CFR 558.4 - Requirement of a medicated feed mill license.

View all text of Subpart A [§ 558.3 - § 558.6]

§ 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.

(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.