FDA Final Rule Cephalosporin Use in Food Producing Animals issued

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Re: See message below with attached Federal Register and brief statement from Animal Health Institute as attachments.

The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012. FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.

Antimicrobial drugs are important for treating disease in both humans and animals. This new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but revoked prior to implementation.

In its order, FDA is prohibiting what are called “extralabel” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals. Specifically, the prohibited uses 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.
In 2008, FDA issued and then revoked an order that prohibited extralabel uses of cephalosporins in food-producing animals with no exceptions. Today’s announcement responds to public comment and includes the following exceptions, which protect public health while considering animal health needs:

The order does not limit the use of cephapirin, an older cephalosporin drug that is not believed by FDA to contribute significantly to antimicrobial resistance.
Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label 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.
For the full FDA News Release, which includes links to Questions and Answers, please go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285704.htm

An advance version of the Federal Register notice, to be published on January 6, 2012, is attached below:

Attachments:

ELDU_statement.docx

ELDU_Order_2012-Cephalosporin_USe_in_Food-Producing_Animals.pdf

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