A key plank in the FDA’s platform to slow down the development of antibiotic resistance and extend the life of medications important to humans is in place. The agency announced Wednesday it has completed the implementation of Guidance for Industry #213.

Known in the animal pharmaceutical industry as GFI #213, the Food and Drug Administration began the process of implementing the guidance in 2013. The goal is to eliminate the use of antimicrobial drugs — which include antibiotics — in animals for the purpose of promoting growth to increase production.

To achieve that goal the FDA sought industry cooperation to delete labeling references to growth or “production” uses and to switch certain medications from over-the-counter status to prescription status.

As of Tuesday, FDA reported, animal drug manufacturers are meeting the new standards for labels on “antimicrobial drugs with importance in human medicine,” also known as medically important antimicrobials. The guidance applies to drugs used in the feed or drinking water of food-producing animals such as pigs and cows.

vetwithpigs“On Dec. 23, 2016, the agency released three Federal Register documents to update the Code of Federal Regulations (CFR) to reflect changes to most of the new animal drug applications affected by GFI #213,” FDA reported Wednesday.

“As of Jan. 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have either aligned with the recommendations outlined in GFI #213, or their approvals have been voluntarily withdrawn.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.”

FDA officials praised the cooperation of the animal pharmaceutical industry for meeting its commitment to fully align all affected products with the GFI #213 recommendations.

The agency acknowledged the role that a number of key stakeholders played in helping to prepare for this transition. Those stakeholders included veterinary organizations, animal producer organizations, feed industry organizations and 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,” FDA officials said in a written statement Wednesday.

Of the 292 new animal drug applications initially affected by GFI #213:

  • 84 were completely withdrawn;
  • 93 applications for oral dosage 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 directives status; and
  • Production, e.g., growth promotion, indications were withdrawn from all 22 applications that included such indications for use.

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:

  • Aligning antimicrobial drug products with the principles of antimicrobial stewardship in veterinary settings;
  • Supporting efforts to foster stewardship of antimicrobials in veterinary settings; and
  • Assessing the impact of strategies intended to curb the emergence of antimicrobial resistance associated with the use of antimicrobial drugs in veterinary settings.

“Antimicrobial drugs have been widely used in veterinary medicine for more than 50 years. When used judiciously, antimicrobials can effectively fight infections and improve animal health,” according to FDA’s initiative statement.

“However, overuse of antimicrobials promotes the development of antimicrobial-resistant bacteria. Today, antimicrobial resistance is a worldwide phenomenon and growing problem. To slow the emergence of resistance and extend the useful life of antimicrobials, stewardship of antimicrobials in both human health and veterinary settings is essential.”

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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