[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.4]
[Page 359-362]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
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 and in
Sec. Sec. 510.515 and 558.15 of this chapter.
(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
[[Page 360]]
medicated articles and Type B and Type C medicated feeds, as follows:
Category I
----------------------------------------------------------------------------------------------------------------
Assay limits
Drug percent \1\ Type B maximum (200x) Assay limits percent \1\ type
type A B/C \2\
----------------------------------------------------------------------------------------------------------------
Aklomide............................ 90-110 22.75 g/lb (5.0%)........... 85-120.
Amprolium with Ethopabate........... 94-114 22.75 g/lb (5.0%)........... 80-120.
Bacitracin methylene disalicylate... 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.
Buquinolate......................... 90-110 9.8 g/lb (2.2%)............. 80-120.
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.
Erythromycin (thiocyanate salt)..... 85-115 9.25 g/lb (2.04%)........... <20g/ton 70-115/150-50:20g/ton 75-125.
Iodinated casein.................... 85-115 20.0 g/lb (4.4%)............ 75-125.
Laidlomycin propionate 90-110 1 g/lb (0.22%).............. 90-115/85-115.
[chyph]potassium.
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.
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 7.2 g/lb (1.6%)............. 85-115/75-125.
Nequinate........................... 95-112 1.83 g/lb (0.4%)............ 80-120.
Niclosamide......................... 85-120 225g/lb (49.5%)............. 80-120.
Nystatin............................ 85-125 5.0 g/lb (1.1%)............. 75-125.
Oleandomycin........................ 85-120 1.125 g/lb (0.25%).......... <11.25 g/ton 70-130; 11.25 g/ton 75-125.
Oxytetracycline..................... 90-120 20.0 g/lb (4.4%)............ 75-125/65-135.
Penicillin.......................... 80-120 10.0 g/lb (2.2%)............ 65-135.
Poloxalene.......................... 90-110 54.48 g/lb (12.0%).......... Liq. feed: 85-115.
Ractopamine......................... 85-105 1.8 g/lb (0.4%)............. 80-110/75-125.
Salinomycin......................... 95-115 6.0 g/lb (1.3%)............. 80-120.
Semduramicin........................ 90-110 2.25 g/lb (0.50%)........... 80-110.
Tiamulin............................ 113.4 g/lb, 3.5 g/lb (0.8%)............. 90-115.
100-108
5 and 10 g/ ............................ 70-130.
1b, 90-115
Tylosin............................. 80-120 10.0 g/lb (2.2%)............ 75-125.
Virginiamycin....................... 85-115 10.0 g/lb (2.2%)............ 70-130.
Zoalene............................. 92-104 11.35 g/lb (2.5%)........... 85-115.
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\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
----------------------------------------------------------------------------------------------------------------
Assay limits
Drug percent \1\ Type B maximum (100x) Assay limits percent \1\ Type
Type A 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.
Arsanilate sodium................... 90-110 4.5 g/lb (1.0%)............. 85-115/75-125.
Arsanilic acid...................... 90-110 4.5 g/lb (1.0%)............. 85-115/75-125.
Carbadox............................ 90-110 2.5 g/lb (0.55%)............ 75-125.
Carbarsone.......................... 93-102 17.0 g/lb (3.74%)........... 85-115.
Clopidol............................ 94-106 11.4 g/lb (2.5%)............ 90-115/80-120.
Famphur............................. 100-110 5.5 g/lb (1.21%)............ 90-115/80-120.
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Fenbendazole........................ 93-113 8.87 g/lb (1.96%)........... 75-125
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.
Levamisole.......................... 85-120 113.5 g/lb (25%)............ 85-125.
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 7.0 g/lb (1.54%)............ 70-125.
Oxytetracycline................... 80-120 10.0 g/lb (2.2%)............ 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
Narasin........................... 90-110 5.675 g/lb (1.25%).......... 85-115/75-125
Nicarbazin (powder)................. 98-106 5.675 g/lb (1.25%).......... 85-115/80-120
Nitarsone........................... 90-110 8.5 g/lb (1.87%)............ 85-120.
Nitromide........................... 90-110 11.35 g/lb (2.5%)........... 80-120.
Sulfanitran....................... 85-115 13.6 g/lb (3.0%)............ 75-125.
Nitromide........................... 90-110 11.35 g/lb (2.5%)........... 85-115.
Sulfanitran....................... 85-115 5.65 g/lb (1.24%)........... 75-125.
Roxarsone......................... 90-110 2.275 g/lb (0.5%)........... 85-120.
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.
Ronnel.............................. 85-115 27.2 g/lb (6.0%)............ 80-120.
Roxarsone........................... 90-110 2.275 g/lb (0.5%)........... 85-120.
Roxarsone........................... 90-110 2.275 g/lb (0.5%)........... 85-120.
Aklomide.......................... 90-110 11.35 g/lb (2.5%)........... 85-120.
Roxarsone........................... 90-110 2.275 g/lb (0.5%)........... 85-120.
Clopidol.......................... 94-106 11.35 g/lb (2.5%)........... 80-120.
Bacitracin methylene disalicylate. 85-115 5.0 g/lb (1.1%)............. 70-130.
Roxarsone........................... 90-110 2.275 g/lb (0.5%)........... 85-120.
Monensin.......................... 90-110 5.5 g/lb (1.2%)............. 75-125.
Sulfadimethoxine.................... 90-110 5.675 g/lb (1.25%).......... 85-115/75-125.
Ormetoprim (5/3).................. 90-110 3.405 g/lb (0.75%).......... 85-115.
Sulfadimethoxine.................... 90-110 85.1 g/lb (18.75%).......... 85-115/75-125.
Ormetoprim (5/1).................. 90-110 17.0 g/lb (3.75%)........... 85-115.
Sulfaethoxypyridazine............... 95-105 50.0 g/lb (11.0%)........... 85-115.
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.
Penicillin........................ 85-115 5.0 g/lb (1.1%)............. 85-125/70-130.
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.
Sulfanitran......................... 85-115 13.6 g/lb (3.0%)............ 75-125.
Aklomide.......................... 90-110 11.2 g/lb (2.5%)............ 85-120.
Sulfanitran......................... 85-115 13.6 g/lb (3.0%)............ 75-125.
Aklomide.......................... 90-110 11.2 g/lb (2.5%)............ 85-120.
Roxarsone......................... 90-110 2.715 g/lb (0.60%).......... 85-120.
Sulfanitran......................... 85-115 13.6 g/lb (3.0%)............ 75-125.
Aklomide.......................... 90-110 11.2 g/lb (2.5%)............ 85-120.
Roxarsone......................... 90-110 2.27 g/lb (0.5%)............ 85-120.
Sulfaquinoxaline.................... 98-106 11.2 g/lb (2.5%)............ 85-115.
Sulfathiazole....................... 85-115 10.0 g/lb (2.2%)............ 80-120.
Chlortetracycline................. 85-125 10.0g/lb (2.2%)............. 70-130.
Penicillin........................ 80-120 5.0 g/lb (1.1%)............. 70-130.
Thiabendazole....................... 94-106 45.4 g/lb (10.0%)........... 7% 85-115; <7% 90-
110.
Tilmicosin.......................... 90-110 18.2 g/lb (4.0%)............ 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 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.
[[Page 362]]
(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 Sec.
558.4, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.