Impact of FDA’s new cephalosporin rules

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The U.S. Food and Drug Administration this week issued new rules for the use of the cephalosporin class of antimicrobial drugs in food animals, which will take effect on April 5 following a comment period.

The new rule, intended to reduce the risk of cephalosporin resistance in pathogens affecting humans, focus primarily on use of the drugs for disease prevention and other off-label uses. As currently worded, the rules should have relatively minor impact on how beef producers and their veterinarians use these drugs in cattle, says Kansas State University veterinarian Mike Apley.

Cephalosporin drugs currently approved for use in cattle include Excede, Naxcel and Excenel, all different formulations of ceftiofur from Pfizer Animal Health.

According to FDA, the new regulations will prohibit these uses: 

  • 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.

The rules will not, Apley notes, prohibit any currently labeled uses for these products, although some clarification of terminology might be necessary. Excede, for example, is labeled for treatment and control of BRD in high-risk animals. “Control” differs from “prevention” in this case, and covers the label use of treating groups of high-risk, high-exposure calves arriving at feedyards or stocker operations. The wording banning use for disease prevention will not affect the ability of veterinarians to prescribe the product in those cases where they see a need for disease control.

The new order will allow veterinarians to prescribe some off-label uses of the drugs, but bans certain unapproved uses such as intravenous  injections of a cephalosporin approved for intramuscular or subcutaneous injection, which Apley says provides virtually no advantage in the case of ceftiorur hydrochloride (Naxcel) due to rapid absorption from injection sites.

The ban on use for disease prevention could, depending on definition, affect some uses of the products, Apley says, such as in post-surgery prophylaxis or to help cows fight off infections after difficult deliveries. Some of these details might need to be addressed during the comment period.

Overall, Apley says the new rules are far less restrictive than the extra-label use prohibition for fluoroquinolone drugs, such as Bayer Animal Health’s Baytril, which prohibit use of these drugs in food animals in any way that deviates from the label.

The new order, according to FDA, takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but withdrew prior to implementation. The American Veterinary Medical Association responded to that original order, and in a statement this week following FDA’s release of the new rules said this: “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.”

 



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Reggie Corpus    
Williamsburg  |  January, 10, 2012 at 11:56 AM

"The U.S. Food and Drug Administration this week issued new rules for the use of the cephalosporin class of antimicrobial drugs in food animals, which will take effect on April 5 following a comment period" Animal drugs are any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug. For assistance with U.S. FDA Animal Drug registration and listing requirements visit http://www.registrarcorp.com/fda-drugs/registration.jsp?lang=en


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