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FDA To Prohibit Extralabel Cephalosporin Use In Livestock



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The U.S. Food and Drug Administration issued an order today to prohibit certain extralabel uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys, effective April 5, 2012.

The FDA issued the order to preserve the effectiveness of cephalosporin drugs for treating disease in humans, the agency said. The FDA issued a similar order in 2008, but revoked the order prior to implementation to consider remarks made during the comment period.

The prohibited uses of cephalosporins in cattle, swine, chickens and turkeys in the latest order include:

• Using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
• Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);
• Using cephalosporin drugs for disease prevention.

Today’s order responds to public comment made following the 2008 order and includes the following exceptions, which protect public health while considering animal health needs, the FDA said:

• The order does not limit the use of cephapirin, an older cephalosporin drug that is not believed by the FDA to contribute significantly to antimicrobial resistance.
• Veterinarians will still be able to use or prescribe cephalosporins for limited extralabel use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.
• Veterinarians may also use or prescribe cephalosporins for extralabel uses in minor species of food-producing animals such as ducks or rabbits.

“We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals,” said Michael Taylor, FDA deputy commissioner for foods.

Comments on the new order can be submitted here with the keyword FDA-2008-N-0326 from Jan. 6, 2012, until March 6, 2012. The FDA will consider the comments prior to the prohibition going into effect in April.

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