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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2020]
[CITE: 21CFR558.4]



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

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart A - General Provisions

Sec. 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 Ethopabate94-11422.75 g/lb (5.0%)80-120.
Avilamycin90-1107.3 g/lb (1.6%)80-110.
Bacitracin methylenedisalicylate85-11525.0 g/lb (5.5%)70-130.
Bacitracin zinc84-1155.0 g/lb (1.1%)70-130.
Bambermycins90-110800 g/ton (0.09%)80-120/70-130.
Chlortetracycline85-11540.0 g/lb (8.8%)80-115/70-130.
Coumaphos95-1156.0 g/lb (1.3%)80-120.
Decoquinate90-1052.72 g/lb (0.6%)80-120.
Dichlorvos100-11533.0 g/lb (7.3%)90-120/80-130.
Diclazuril90-110182 g/t (0.02%)85-115/70-120.
Efrotomycin94-1131.45 g/lb (0.32%)80-120.
Iodinated casein85-11520.0 g/lb (4.4%)75-125.
Laidlomycin propionate potassium90-1101 g/lb (0.22%)90-115/85-115.
Lasalocid95-11540.0 g/lb (8.8%)Type B (cattle and sheep): 80-120; Type C (all): 75-125.
Lincomycin90-11520.0 g/lb (4.4%)80-130.
Lubabegron87-107908 g/ton85-115/80-120.
Melengestrol acetate90-11010.0 g/ton (0.0011%)70-120.
Monensin85-11540.0 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.
Narasin90-1109.0 g/lb (1.98%)85-115/75-125.
Nicarbazin (granular)90-1109.0 g/lb (1.98%)85-115/75-125.
Narasin90-1109.0 g/lb (1.98%)85-115/75-125.
Nystatin85-1255.0 g/lb (1.1%)75-125.
Oxytetracycline90-12020.0 g/lb (4.4%)75-125/65-135.
Poloxalene90-11054.48 g/lb (12.0%)Liq. feed: 85-115.
Ractopamine85-1052.46 g/lb (0.54%)80-110/75-125.
Salinomycin90-1106.0 g/lb (1.3%)80-120.
Semduramicin (as semduramicin sodium)90-1102.27 g/lb (0.50%)80-110
Semduramicin (as semduramicin sodium biomass)90-1102.27 g/lb (0.50%)80-120
Tylosin80-12010.0 g/lb (2.2%)75-125.
Tylvalosin90-1103.86 g/lb85-115.
Virginiamycin85-11510.0 g/lb (2.2%)70-130.
Zoalene92-10411.35 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
Amprolium94-11411.35 g/lb (2.5%)80-120.
Apramycin88-1127.5 g/lb (1.65%)80-120.
Carbadox90-1102.5 g/lb (0.55%)75-125.
Clopidol94-10611.4 g/lb (2.5%)90-115/80-120.
Erythromycin85-1154.625 g/lb (1.02%)75-125.
Famphur100-1105.5 g/lb (1.21%)90-115/80-120.
Fenbendazole93-1138.87 g/lb (1.96%)75-125.
Florfenicol90-1109.1 g/lb (2.0%)Swine feed: 85-115
Catfish feed: 80-110.
Salmonid feed: 80-110.
Halofuginone hydrobromide90-115272.0 g/ton (.03%)75-125.
Hygromycin B90-1101,200 g/ton (0.13%)75-125.
Ivermectin95-1051,180 g/ton (0.13%)80-110.
Maduramicin ammonium90-110545 g/ton (.06%)80-120.
Morantel tartrate90-11066.0 g/lb (14.52%)85-115.
Neomycin80-12020 g/lb (4.4%)70-125.
Oxytetracycline80-12020 g/lb (4.4%)65-135.
Neomycin sulfate80-120100 g/lb (22.0%)70-125.
Nicarbazin (granular)90-1105.675 g/lb (1.25%)85-115/75-125.
Nicarbazin (powder)96-1049.08 g/lb (2.00%)85-115/75-125.
Novobiocin85-11517.5 g/lb (3.85%)80-120.
Pyrantel tartrate90-11036 g/lb (7.9%)75-125.
Robenidine95-1151.5 g/lb (0.33%)80-120.
Sulfadimethoxine90-110Poultry: 5.675 g/lb
Fish: 85.1 g/lb
80-115/75-125.
Ormetoprim90-110Poultry: 3.405 g/lb
Fish: 17.0 g/lb
80-115.
Sulfamerazine85-11518.6 g/lb (4.0%)85-115.
Sulfamethazine85-11510.0 g/lb (2.2%)80-120.
Chlortetracycline85-11510.0 g/lb (2.2%)85-125/70-130.
Sulfamethazine85-11510.0 g/lb (2.2%)80-120.
Tylosin80-12010.0 g/lb (2.2%)75-125.
Sulfaquinoxaline98-10611.2 g/lb (2.5%)85-115.
Thiabendazole94-10645.4 g/lb (10.0%)>7% 85-115; <7% 90-110.
Tiamulin hydrogen fumarate90-11510 g/lb90-115/70-130.
Tilmicosin90-11037.9 g/lb (8.35%)Swine Type B/C feed: 85-115.
Cattle Type B feed: 85-115.
Cattle Type C feed: 80-110.
Zilpaterol90-110680 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.

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