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FDA Promotes Changes to Use of Animal Antibiotics

Apr 18, 2012

The Food and Drug Administration announced a voluntary initiative last Friday that will phase in changes to how certain antimicrobial drugs, or antibiotics, are labeled and used in food-producing animals. FDA said it's taking the action to help preserve the effectiveness of medically important antibiotics for treating disease in humans.

Antimicrobial resistance occurs when bacteria or other microbes develop the ability to resist the effects of a drug. Once this occurs, a drug may no longer be as effective in treating various illnesses or infections.

"Because it is well established that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary," FDA said in a news release.

Under the new initiative, certain antibiotics would not be used for production purposes, such as to enhance growth or improve feed efficiency in an animal. The antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.

"This announcement underscores the continued significance of good dairy farming practices," said Jonathan Gardner, IDFA vice president of regulatory affairs. "It's important for processors to work with the producers who supply their operations to ensure that they follow the voluntary guidance."

As part of the initiative, FDA published three documents in the Federal Register.

  • A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
  • A draft guidance, open for public comment, will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding scientifically-supported disease prevention, control and treatment uses; and changing the marketing status to include veterinary oversight.
  • A draft proposed Veterinary Feed Directive regulation, open for public comment, outlines ways that veterinarians can authorize the use of certain animal drugs in feed in an effort to make veterinary oversight feasible and efficient.

For more information, contact Gardner at

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