July 2, 2008
FDA Issues Order Prohibiting Extralabel Use of Cephalosporin Antimicrobial Drugs in Food-Producing Animals
On July 3, 2008, the U.S. Food and Drug Administration (FDA) published a final rule that prohibits the extralabel use of cephalosporin antimicrobial drugs in food-producing animals, including, but not limited to cattle, swine, chickens, and turkeys. This rule will help further protect consumers against antimicrobial-resistant strains of zoonotic foodborne bacterial pathogens.
By law, FDA may issue a prohibition order if evidence shows that extralabel use of a drug in food-producing animals has caused, or is likely to cause, a public health risk. In this case, FDA has gathered evidence showing that the extralabel use of cephalosporins in food-producing animals is likely to contribute to the emergence of resistance and compromise human therapies. Given the importance of the cephalosporin class of drugs for treating disease in humans, FDA believes that preserving the effectiveness of such drugs is critical. Therefore, FDA believes it is necessary to take action to limit the extent to which extralabel use of cephalosporins in food-producing animals may be contributing to the emergence of resistant variants.
The prohibition of extralabel use of cephalosporin antimicrobial drugs in food-producing animals will protect the public health by preserving the effectiveness of cephalosporin-class drugs for the treatment of human infections.
Comments on the rule may be submitted until September 2, 2008. The rule will go into effect on October 1, 2008.
Final Rule, New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, July 3, 2008
Cephalosporin Order of Prohibition: Questions and Answers, July 16, 2008
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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