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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Makes the Analysis of Comments on the Fluoroquinolone and Glycopeptide Prohibition Available to the Public

January 15, 1998

The Center for Veterinary Medicine is making available to the public its analysis of comments on the prohibition of the extralabel use of fluoroquinolone and glycopeptide antibiotics in food-producing animals. Copies of this analysis may be obtained from CVM's Internet Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, telephone: 301-594-1755.

In the May 22, 1997 Federal Register, FDA published a prohibition against the extralabel use in food-producing animals of fluoroquinolone and glycopeptide antibiotics. Enrofloxacin and vancomycin are examples of antibiotics in each of these classes. The prohibition is based on a finding by the FDA that the extralabel use of these antibiotics in food-producing animals presents a risk to the public health. These extralabel uses are capable of increasing the antibiotic resistance of the bacteria that can cause human illness and that are present in treated animals at the time of slaughter.

The Animal Medicinal Drug Use Clarification Act (AMDUCA) authorizes the issuance of an order of prohibition. The AMDUCA of 1994 amended the Federal Food, Drug, and Cosmetic Act to allow licensed veterinarians to prescribe extralabel uses of approved animal drugs and human drugs in animals. The implementing regulations for AMDUCA were published in the Federal Register on November 7, 1996, and codified in the Code of Federal Regulations (CFR) in Title 21, Part 530. The AMDUCA regulations provide an opportunity for public comment, and that the order of prohibition becomes effective 90 days after the date of publication, unless FDA revokes or modifies the order, or extends the period of public comment.

FDA did not revoke or modify the order, or extend the period for public comment. Accordingly, the prohibition on the extralabel use in food-producing animals of fluoroquinolone and glycopeptide antibiotics became effective on August 20, 1997.

FDA received 15 comments relating to this action. These comments and the analysis are available for review in the Public Reading Room of the Dockets Management Branch (HFA-305), Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. Questions about the order of prohibition and the analysis of comments may be directed to Richard L. Arkin, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0141.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855