§ 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.

(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 percent1 Type A	Type B maximum (200x)	Assay limits percent1 Type B/C2
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 percent1 Type A	Type B maximum (100x)	Assay limits percent1 Type B/C2
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.
Thiabendazole	94–106	45.4 g/lb (10.0%)	>7% 85–115; <7% 90–110.
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

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.