FDA to Ban Cephalosporin Extra Label Use

July 3, 2008 — 

The U.S. Food and Drug Administration (FDA) issued a final rule on July 3, 2008 prohibiting the extra-label use of cephalosporins (including ceftiofur in swine) in food-producing animals. The agency is issuing this order based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to the public health. Public comment regarding the rule will be accepted until September 2, 2008 and the rule will go into effect on October 1, 2008.

This action would add cephalosporin antimicrobials to the list of drugs prohibited for extra-label use by the FDA. Given the recent approval of Baytril® for use in swine, it is important to remember that it too is among another class of drugs, fluoroquinolones, that are also prohibited for extra-label use in food animals.

Under the Animal Medicinal Drug Use Clarification Act (AMDUCA) drugs on this list may not be used under any circumstances in an extra-label manner even by a veterinarian.

Watch this week's e-Letter for a review of AMDUCA.