The issue of medicated feeds for food animals has drawn considerable attention lately, as the FDA has proposed significant rule changes that will have practical implications for livestock producers and veterinarians.

Specifically, the agency has issued a guidance for industry, entitled “Judicious Use of Medically Important Antimicrobials in Food Producing Animals,” which establishes the framework for phasing out production uses of antimicrobials important in treating humans, and phasing in veterinary oversight of the remaining therapeutic uses of such drugs.

FDA also issued a draft guidance that will assist drug companies seeking to voluntarily revise product labels to remove production uses and to voluntarily change the marketing status of these medically important antimicrobials to include veterinary oversight or supervision.

Finally, FDA provided draft text for a proposed regulation intended to improve the efficiency of existing Veterinary Feed Directive (VFD) requirements. VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian.

To summarize the issues and outline the proposed changes, the FDA’s Center for Veterinary Medicine and the American Academy of Veterinary Pharmacology and Therapeutics held a workshop on May 22 and 23 in Potomac, Maryland. The workshop’s presentations now are available on the FDA website.

  • Conference presentation topics include:
  • New animal drugs for use in animal feeds: types and categories
  • Development and approval of labeling for medicated feeds
  • Where to find approved labeling for medicated feed
  • Proposed changes - Veterinary Feed Directive
  • Antimicrobial drugs in animal feeds: Update on FDA's judicious use strategy
  • Generic approval process and biowaiver requirements
  • Data to support medicated feeds
  • Medicated feed assay methods and limits: regulatory perspective
  • What do feed mill inspections have to do with drug approvals?

The workshop proceedings also include round-table discussions of the topics following each day’s sessions.

View the full workshop or selected individual sessions on the FDA website.