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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Revokes Order Prohibiting Extralabel Use of Cephalosporin

November 25, 2008

The Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. The agency is taking this action today so that it may fully consider the many substantive comments it received on the order of prohibition.

The order, which was to take effect on November 30, 2008, would have changed 21 CFR 530.41 to list cephalosporins as prohibited from extralabel use in food-producing animals. It was originally announced in the Federal Register on July 3, 2008 with a 60-day comment period and a 90-day effective date for the final rule; however, on August 18, 2008, the agency extended the comment period to November 1 to allow adequate time for interested persons to submit comments, thus delaying the implementation of the rule until November 30, 2008.

The agency received many substantive comments on the order of prohibition, and therefore, in order for FDA to fully consider the comments, the agency has decided to revoke the order. As a result, the order of prohibition will not take effect on November 30, 2008. Neither the order nor the change to § 530.41 that would have listed cephalosporins as prohibited from extralabel use will take effect on November 30, 2008. If, after considering the comments and other relevant information, FDA decides to issue another order of prohibition addressing this matter, FDA will follow the procedures in 21 CFR 530.25 that provide for a public comment period prior to implementing the order.

For additional information, please see Cephalosporin Order of Prohibition: Questions and Answers and the Federal Register Notice.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855