September 15, 2008


 FDA extends comment period on cephalosporin restrictions

Posted Sept. 1, 2008

The Food and Drug Administration has extended the comment period on a final rule to prohibit extralabel uses of cephalosporins in food animals.

According to the rule, the FDA decided on the prohibition because of information supporting the agency's conclusion that extralabel uses of the cephalosporin class of antimicrobial drugs are likely contributing to the emergence of cephalosporin-resistant foodborne pathogens (see JAVMA, Aug. 1, 2008).

Various parties asked the FDA to extend the comment period so they could examine the available evidence, consider the impact of the ruling, and provide constructive comment. The agency granted an additional 60 days, extending the comment period to Nov. 1 and delaying the effective date of the final rule to Nov. 30.

The AVMA will review the FDA proposal in detail and furnish science-based comments to the agency. Current AVMA policy advocates that the FDA Center for Veterinary Medicine consider limited prohibition on the extralabel use of any drug considered for prohibition in food animals, consistent with protection of the food supply, public health, and animal welfare.

The order prohibiting extralabel use of cephalosporins in food animals appeared in the July 3 Federal Register, available at

Parties may submit comments on Docket No. FDA-2008-N-0326 electronically at or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.