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FDA completes implementation of medically important antimicrobial rule updateFDA completes implementation of medically important antimicrobial rule update

Agency also outlines continuing efforts to address antimicrobial resistance.

January 4, 2017

3 Min Read
FDA completes implementation of medically important antimicrobial rule update

The U.S. Food & Drug Administration announced Jan. 3 that it has completed the implementation of Guidance for Industry 213 (GFI #213), a process started 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, FDA released three Federal Register documents to update the "Code of Federal Regulations" (CFR) reflecting changes to most of the new animal drug applications affected by GFI #213.

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drug applications have either aligned with the recommendations outlined in GFI #213, or their approvals have been withdrawn voluntarily. As a result of these changes, these products cannot be used for production purposes (like growth promotion) and may be used only under the authorization of a licensed veterinarian.

FDA said it 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, animal producer and 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.

FDA said it 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Of the 292 new animal drug applications initially affected by GFI #213, 84 were completely withdrawn. Of the remaining 208 applications, 93 for oral dosage form products intended for use in water were converted from over-the-counter to prescription status, and 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status. Furthermore, production indications (e.g., growth promotion) 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, FDA said, noting that it is committed to ongoing collaboration with key stakeholders to support antimicrobial stewardship.

Moving forward, FDA said it 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 effect of strategies intended to curb the emergence of antimicrobial resistance associated with the use of antimicrobial drugs in veterinary settings.

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


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