(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

Open Table
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.

1Percent of labeled amount.

2Values 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

Open Table
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%) 85-115/75-125.
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.

1Percent of labeled amount.

2Values 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]


Tried the LawStack mobile app?

Join thousands and try LawStack mobile for FREE today.

  • Carry the law offline, wherever you go.
  • Download CFR, USC, rules, and state law to your mobile device.