[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.4] [Page 356-359] 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 Secs. 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 medicated articles and Type B and Type C medicated feeds, as follows: [[Page 357]] 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 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. Melengestrol acetate................ 90-110 10.0 g/ton (0.0011%)........ 70-120. Monensin............................ 90-110 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. 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. ---------------------------------------------------------------------------------------------------------------- \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. 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. [[Page 358]] 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.................... 95-115 5.675 g/lb (1.25%).......... 85-115/75-125. Ormetoprim (5/3).................. 95-115 3.405 g/lb (0.75%).......... 85-115. Sulfadimethoxine.................... 95-115 85.1 g/lb (18.75%).......... 85-115/75-125. Ormetoprim (5/1).................. 95-115 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. (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] [[Page 359]] 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.