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FDA Issues Guidances and Proposed Rule to Phase Out Antimicrobials for Animal Feed & Growth

The Food and Drug Administration released three documents to phase out the use of medically important drugs for feed efficiency or growth promotion in food-producing animals and provide that they be used only for animal health purposes under the supervision of a veterinarian. The three documents include: (1) a final guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, which establishes a framework for phasing out the use of these drugs for feed efficiency or growth promotion and phasing in veterinary consultation or oversight of their medical uses in food-producing animals; (2) a draft guidance, for public comment, to drug companies on how to revise product labels for important antimicrobial drugs to no longer include use for feed efficiency or growth promotion, and include veterinary oversight or consultation; and (3) a draft proposed regulation, also for public comment, amending the regulation that governs veterinary authorization for the use of certain drugs in animal feed.

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FDA notice announcing availability of Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals (FR Pub 04/13/12) available here.

FDA's proposed Veterinary Feed Directive (FR Pub 04/13/12) available here.

FDA notice announcing availability of Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209 (FR Pub 04/13/12) available here.