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On January 3 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.
The Guidance for Industry #213 was intended for sponsors of approved applications for new animal drugs and new animal drug combination products containing medically important antimicrobial new animal drugs for use in or on medicated feed or water of food-producing animals. The guidance contains information for sponsors of such new animal drugs and combination products to facilitate voluntary changes to the conditions of use for such new animal drugs and combination products consistent with FDA’s recommendations included in the guidance document entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals” (Judicious Use Guidance, GFI #209).
On December 23, 2016, the agency 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. The FDA can now report that, as of January 3, 2017, 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have either aligned with the recommendations outlined in GFI #213, or their approvals have been voluntarily withdrawn.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 form 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
Tuesday January 3, 2017/ FDA/ United States.
http://www.fda.gov
