Approval Date: September 22, 1997
I. GENERAL INFORMATION:
One Executive Drive
Fort Lee, New Jersey 07024
amprolium, ethopabate, bacitracin zinc, roxarsone
Amprol Hi-E®, Albac®, 3-Nitro®
II. EFFECTIVENESS AND TARGET ANIMAL SAFETY
In accordance with the Center for Veterinary Medicine's policy letter dated November 2, 1989, as published in the Federal Register on January 30, 1990 (55 FR 3107), following the approval of an ANADA for a generic Type A Medicated article (ANADA 200-223, generic bacitracin zinc), ALPHARMA, Inc., is entitled to the approval of generic bacitracin zinc in combination with amprolium and ethopabate, and roxarsone. Bioequivalence studies are not required for the approval of this generic combination (Type C Medicated feed). Bacitracin zinc is codified under 21 CFR §558.78. Amprolium and ethopabate is codified under 21 CFR §558.58. Roxarsone is codified under 21 CFR §558.530. The combination of bacitracin zinc, amprolium and ethopabate, and roxarsone is codified under 21 CFR §558.58 (d) (1) (iii).
III. HUMAN SAFETY
Tolerances for the Marker Residue
The tolerances established for the pioneer bacitracin zinc product apply to the generic bacitracin zinc product.
The tolerances for residues of bacitracin from bacitracin zinc are established at 0.5 ppm (0.02 unit per gram), negligible residue, in uncooked edible tissues of chickens (21 CFR §556.70).
Tolerances for amprolium residues in chickens are established at 1.0 ppm in the uncooked liver and kidney and 0.5 ppm in uncooked muscle (21 CFR §556.50).
Tolerances for ethopabate residues converted to m-phenetidine in chickens are established at 1.5 ppm in the uncooked liver and kidney and 0.5 ppm in uncooked muscle (21 CFR §556.260).
Tolerances for arsenic residues (from roxarsone) are established at 0.5 ppm in uncooked muscle and 2 ppm in uncooked edible by-products of chickens (21CFR§556.60)
Based on the information in 21 CFR §558.58(d)(1)(iii), a 5-day withdrawal time is required for the use of the combination of bacitracin with amprolium, ethopabate and roxarsone in broiler chickens.
Regulatory Method for Residues
The regulatory analytical method for detection of residues of bacitracin is a microbiological test using Sarcina subflava (ATCC 7468) or Micrococcus subflavus (ATCC 10240). The method is found in Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports and Protocols, Revised October 1968, Reprinted December 1974, National Center for Antibiotic and Insulin Analysis, FDA, Washington, DC 20204.
Modified Method for the Determination of Bacitracin in Tissues, Test Procedure Code 9A, AL Laboratories, One Executive Dr. PO Box 1399, Fort Lee NJ 07024.
The regulatory analytical method for detection of residues of amprolium is a fluorimetric test. A description of the regulatory method is filed in the Food Additives Analytical Manual that is on display in FDA's Freedom of Information Public Room, 5600 Fishers Lane, Rockville, MD 20857.
The analytical method for the determination of ethopabate in tissues uses a gas chromatographic assay procedure that measures the 2,4 dinitrophenyl derivative of m-phenetidine produced following acid hydrolysis of ethopabate. This method is found in JAOAC 53:461 (1970).
The analytical method for the determination of roxarsone in tissues is a spectrophotometric method. The method is titled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method" published in Official Methods of Analysis of AOAC International, 16th edition.
IV. AGENCY CONCLUSIONS
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that the combination of amprolium, ethopabate, bacitracin zinc, and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
- Type C medicated Feed (Blue Bird) - Generic
- Type C medicated Feed (Blue Bird) - Pioneer
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855