Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTSPart 558 - NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart A - GENERAL PROVISIONS
Section 558.4 - Requirement of a medicated feed mill license

21 C.F.R. § 558.4

Download
PDF
Current through September 30, 2024
Section 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

DrugAssay limits percent1 Type AType B maximum (200x)Assay limits percent1 Type B/C2
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

DrugAssay limits percent1 Type AType B maximum (100x)Assay limits percent1 Type B/C2
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%)85-115/80-120.
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.
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.

21 C.F.R. §558.4

51 FR 7392, Mar. 3, 1986
81 FR 11665, 3/7/2016; 81 FR 17608, 3/30/2016; 81 FR 36789, 36790, 6/8/2016; 81 FR 59134, 8/29/2016; 81 FR 94995, 12/27/2016; 82 FR 21691, 5/10/2017; 82 FR 43485, 9/18/2017; 83 FR 13636, 3/30/2018; 83 FR 48947, 9/28/2018; 84 FR 12495, 4/2/2019; 84 FR 53311, 10/7/2019; 85 FR 4209, 1/24/2020; 87 FR 58963, 9/29/2022; 89 FR 14411, 2/27/2024

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.