Approval Date: January 16, 1998
I. GENERAL INFORMATION:
Hoffmann-La Roche Inc.
Chlortetracycline, Bacitracin Methylene Disalicylate
BMD®-25, BMD®-30, BMD®-40, BMD®-50, BMD®-60 or BMD®-75; and Aureomycin® -50, -70, -80, -90 or -100.
Over the Counter (OTC)
II. INDICATIONS FOR USE
Bacitracin methylene disalicylate Type A medicated articles (NADA 46-592): For increased rate of weight gain and improved feed efficiency.
Chlortetracycline Type A medicated articles (NADA 48-761): For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Type A medicated articles
ROUTE OF ADMINISTRATION
These drugs are administered orally by
adding the Type A medicated articles to
complete swine feed (Type C medicated feed).
10 to 30 grams bacitracin methylene disalicylate per ton and 400grams chlortetracycline per ton. Feed for not more than 14 days.
IV. & V. EFFECTIVENESS AND ANIMAL SAFETY:
Aureomycin[[dieresis]] (chlortetracycline) and CTC[[dieresis]] were both found to comply with the results of NAS/NRC and DESI evaluation for effectiveness as published in the Federal Register (61 FR 35949-35958; July 9, 1996). These products approved under the DESI process were found to be equivalent at the codified level 21 CFR [[section]]558.128(d)(1)(xii) of 10 mg per pound of body weight per day for swine (61 FR 35949-35958; July 9, 1996).
The Center's fourth policy letter dated November 2, 1989, as published in the Federal Register on January 30, 1990 (55 FR 3107), states that the approval of a new generic Type A Medicated article entitles the sponsor to approval of all the feed combinations for which the pioneer is approved. Bioequivalency and tissue residue studies are not required for approval of the feed use combinations.
Bacitracin MD is codified under 21 CFR [[section]]558.76. Chlortetracycline (Aureomycin[[dieresis]] - Roche) is codified under 21 CFR [[section]]558.128(d)(1). Chlortetracycline (CTC[[dieresis]] - Alpharma) is codified under 21 CFR [[section]]558.128(d)(1). The combination of bacitracin MD and chlortetracycline is codified under 21 CFR [[section]]558.128(d)(3)(xiv) and 558.76(d)(1).
VI. HUMAN SAFETY:
Tolerances for the Marker Residue
The tolerances established for the pioneer bacitracin product apply to the generic bacitracin product.
The tolerances for residues of bacitracin from bacitracin methylene disalicylate are established at 0.5part per million (0.02 unit per gram), negligible residue, in uncooked edible tissues of swine (21CFR[[section]]556.70).
Tolerances for the sum; of residues of the tetracyclines including chlortetracycline, in tissues of swine are as follows: (a) 2 parts per million (ppm) in muscle; (b) 6 ppm in liver; (c) 12 ppm in fat and kidney. (21CFR[[section]]556.150)
Based on the information in 21 CFR [[section]]558.76 (d)(1) and in 21CFR [[section]]558.128(d)(3)(xiv), a zero-day withdrawal time is established for the use of the combination of bacitracin with chlortetracycline in swine.
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, NJ07024.
The regulatory analytical method for detection of residues of chlortetracycline is a microbiological test using Bacillus cereus var mycoides (ATCC 11778). The method is found in Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports and Protocols, Revised October 1968, Reprinted December 1974, Nation Center for Antibiotic and Insulin Analysis, FDA, Washington, DC 20204.
VII. 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 chlortetracycline and bacitracin methylene disalicylate, when used under its proposed conditions of use, is safe and effective for its labeled indications.
VIII. LABELING (Attached)
- 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:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.