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FDA Restricts Extralabel Cephalosporin Use

The U.S. Food and Drug Administration (FDA) issued an order (FDA-2008-N-0326) on January 4, 2012 prohibiting certain uses of cephalosporins in food-producing animals. FDA is prohibiting the extralabel use of cephalosporin antimicrobial drugs (not including cephapirin) in cattle, swine, chickens, and turkeys: (1) For disease prevention purposes; (2) at unapproved doses, frequencies, durations, or routes of administration; and (3) if the drug is not approved for that species and production class. FDA will accept public comments on the order until March 6, 2012. The order will be effective on April 5, 2012 following consideration of the comments received. To comment on the order of prohibition, visit http://www.regulations.gov and enter FDA-2008-N-0326 in the keyword box.

What this means for swine is that:

  1. cephalosporins may continue to be used as labeled without restriction,
  2. veterinarians may prescribe cephalosporins for use in an extralabel manner for indications not listed on the label as allowed within the confines of the Animal Medicinal Drug Use Clarification Act (AMDUCA),
  3. cephalosporins prescribed for extralabel indications may only be used at the dose, frequency, duration and routes of administration approved on the product label. Thus, for example, oral administration of cephalosporins in swine would be illegal. However, a single intramuscular injection of 5.0 mgs/kg of Excede®, for instance, to treat a susceptible disease not listed on the label would be legal assuming all criteria for AMDUCA were met,
  4. the use of cephalosporins for the prevention of disease is prohibited, and
  5. the use of cephalosporin drugs intended for humans or companion animals in food-producing animals is illegal.

In July 2008, the FDA issued a similar but much broader order prohibiting all extralabel uses of cephalosporins in food-producing animals with no exceptions. The agency ultimately revoked that order upon consideration of comments questioning the scientific justification supporting such a prohibition. This is an effort to refine the order to restrict specific practices considered by the agency to contribute to the development of antimicrobial resistance in certain pathogens.