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News and analysis on the global poultry
and animal feed industries.
on December 11, 2008

U.S. FDA reverses order on animal antibiotics

Extra-label drug use of cephalosporin now permitted.

The U.S. Food and Drug Administration (FDA) has revoked a prior order that would have prohibited the “extralabel” use of cephalosporin antimicrobial drugs in food-producing animals. The original order would have taken effect on November 30. The FDA said it revoked the order so that it could “fully consider the many substantive comments it received on the order of prohibition.”

Extralabel drug use refers to the use of a veterinary drug in a manner for which it was not approved, similar to off-label drug use in human medications. Extralabel drug use occurs when a drug only approved for human use is used in animals, when a drug approved for one species of animal is used in another species or when a drug is used to treat a condition for which it was not approved. Only veterinarians are allowed to prescribe drugs extralabel.

The Wall Street Journal reported that the FDA’s submission this year to ban extralabel uses of cephalosporin antibiotic drugs in “food-producing” animals such as cows, swine, and chickens met with industry criticism. Some agriculture groups and animal-drug makers argued that the drugs are necessary for infectious disease prevention in animals, said the Journal.

The FDA said that since it received many substantive comments on the order of prohibition, it was revoking its earlier regulation and would allow cephalosporin use in these animals. However, the agency added that if after considering the comments and other relevant information, it decides to issue another order of prohibition addressing the matter, it would provide for a public comment period prior to implementing the order.

For additional information, see Cephalosporin Order of Prohibition: Questions and Answers and the Federal Register Notice.
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