Regulatory Focus™ > News Articles > FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

Posted 04 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration today released an order, titled, "New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition", that is aimed at prohibiting the off-label use of cephalosporin antimicrobial drugs in certain food-producing animals.

The agency found that off-label use of the antimicrobial in food-producing animals was likely to be unsafe and represent a risk to the public.

The rule follows an attempt to regulate the antimicrobial in July of 2008.  In response to comments, that original date was pushed back for an initial 60 days.  In response to further comments in August of 2008, the agency revoked the order, and withdrew the final rule in November of 2008.

Prior comments to the rule collapsed in to two general categories:

  • The rule was too broad, and prohibited some judicious off-label uses of cephalosporin; and
  • The FDA was not legally justified to issue the order as it was precautionary, and not in response to any real or actual threat.

FDA's new revision takes in to account the comments received in response to the first category.

The new order will prohibit the off-label use of cephalosporin in cattle, swine, chickens, and turkeys.  Specifically, the order bans cephalosporin use:

  • for disease-prevention purposes;
  • at unapproved doses;
  • at unapproved frequencies;
  • at unapproved durations; and
  • at unapproved routes of administration.

Further, the order bans the use of cephalosporin drugs not specifically approved for major food species. 

However, the order does not prohibit the use of cephalosporin in minor food-producing species.

The rule becomes final 90 days after the rule's publication in the Federal Register (6 January).

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