Update (2/17/17): CVM has completed its audit of affected applications and revised the final number of new animal drug applications that have withdrawn production indications from 22 to 31.
January 3, 2017
Today, 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 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have either aligned with the recommendations outlined in GFI #213, or their approvals have been voluntarily withdrawn.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- 84 were completely withdrawn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 (31) 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.
- List of Affected Applications
- Blue Bird Labels
- Update on Implementation of FDA’s Guidance for Industry #213
- FDA’s CVM Key Initiatives for Antimicrobial Stewardship
- New Animal Drugs; Withdrawal of Approval of a New Animal Drug Applications (Notice of Availability)
- Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications (Final Rule)
- New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications (Final Rule)