April 13, 2012 - FDA Guidance for Industry on Judicious Use of Antimicrobial Drugs in Animals

On April 11, the Food and Drug Administration (FDA) announced the publication of three documents in the April 13 Federal Register that are intended to phase out the use of antibiotics for growth promotion in food-producing animals. The FDA is proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals.   Under the initiative, certain antibiotics would not be used for production purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illness in food-producing animals under the supervision of a veterinarian.

The FDA documents include:

  • a final Guidance for Industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs; Guidance Document GFI #209.  The Federal Register Notice for GFI 209 is available by clicking here.  Written comments can be submitted anytime to the Division of Dockets Management (HFA-305).
  • a draft guidance, open for public comment until July 12, will assist drug companies in voluntarily removing production uses of antibiotics from their FDA approved product labels; adding, where appropriate, scientifically supported disease prevention, control and treatment uses; and changing the marketing status to include veterinary oversight;  Draft Guidance Document GFI #213The Federal Register Notice for GFI 213 is available by clicking here.
  • a draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.  The Federal Register notice is available by clicking here

Comments for all of the Guidance Documents and proposed regulations are due July 12, 2012.