FDA concludes medically important antimicrobials transition process

FDA announces implementation of GFI 213, outlines continuing efforts to address antimicrobial resistance.

January 6, 2017

2 Min Read
FDA concludes medically important antimicrobials transition process
U.S. Food and Drug Administration

The U.S. Food and Drug Administration announced that it has completed the implementation of Guidance for Industry 213, a process begun in 2013 to transition antimicrobial drugs with importance in human medicine (medically important antimicrobials) that are used in the feed or drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for production (e.g., growth promotion) purposes.

On Dec. 23, 2016, the agency released three Federal Register documents to update the Code of Federal Regulations reflecting changes to most of the new animal drug applications affected by GFI 213. The FDA can now report that, as of Jan. 3, all affected drug applications have either aligned with the recommendations outlined in GFI 213, or their approvals have been voluntarily withdrawn. As a result of these changes, these products cannot be used for production (e.g. growth promotion) purposes and may only be used under the authorization of a licensed veterinarian.

The FDA appreciates the cooperation of the animal pharmaceutical industry for meeting its commitment to fully align all affected products with the GFI 213 recommendations. The agency acknowledges the role that a number of key stakeholders have played in helping to prepare for this important transition. This includes, but is not limited to, veterinary organizations, animal producer organizations, feed industry organizations, as well as various local, state and federal agencies. The success of this collaborative effort marks an important step forward for promoting antimicrobial stewardship in animals. The FDA realizes that some farmers, ranchers, veterinarians and others may face challenges as they adjust to these changes and the agency is committed to continue working with stakeholders to ensure a smooth transition.

Of the 292 new animal drug applications initially affected by Guidance for Industry 213:

  • 84 were completely withdrawn

  • Of the remaining 208 applications,

    • 93 applications for oral dosage for products intended for use in water were converted from over-the-counter to prescription status,

    • 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status

  • Production (e.g. growth promotion) indications were withdrawn from all (22) applications that included such indications for use

The implementation of GFI 213 is a significant milestone in national efforts to address the use of medically important antimicrobials in food-producing animals. The FDA is committed to ongoing collaboration with key stakeholders to support antimicrobial stewardship. Moving forward, the FDA intends to focus its efforts on such issues as (1) Aligning antimicrobial drug products with the principles of antimicrobial stewardship in veterinary settings; (2) Supporting efforts to foster stewardship of antimicrobials in veterinary settings; and (3) Assessing the impact of strategies intended to curb the emergence of antimicrobial resistance associated with the use of antimicrobial drugs in veterinary settings.

For more information about the FDA’s goals and planned activities for promoting antimicrobial stewardship, see the FDA’s CVM Key Initiatives for Antimicrobial Stewardship.

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