FDA Issues More Targeted ELDU Prohibition on Cephalosporins

In today’s news, an FDA press release announces a revised Order of Prohibition on Extra Label Drug Use of Cephalosporins in the major food producing animal species – cattle, swine, chickens, and turkeys. If you’re a veterinarian working with livestock, you’re probably wondering how this affects you.

This new FDA order is a modification of a 2008 order that was revoked. The original order prohibited all extralabel use of cephalosporins in food-producing animals. This new order achieves a better balance of animal health and public health.

According to the order, the following extralabel uses are specifically prohibited:

  • 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 approved for use in humans or companion animals);
  • Using cephalosporin drugs for disease prevention.

The following extralabel uses are not prohibited by this order, but veterinarians must still follow the regulations outlined under 21 CFR Part 530 for the Animal Medicinal Drug Use Clarification Act (AMDUCA):

  • 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.

The AVMA responded to the original order of prohibition in 2008.  We are pleased to see that the FDA has thoughtfully reviewed the many substantive comments received from the stakeholders and that the revised Order of Prohibition is more consistent with AVMA policy.

Need more information on extralabel drug use? See our ELDU brochure (pdf).

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