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GFI #213


It’s official: FDA implements GFI #213, paving way for new VFD rules

After years of planning, FDA said it has completed implementation of what it calls Guidance for Industry #213 — a process that requires antimicrobials with importance in human medicine to be used under veterinary oversight when added to the feed or drinking water of food-producing animals.

“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have either aligned with the recommendations outlined in GFI #213, or their approvals have been voluntarily withdrawn,” the agency said in a statement.

“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 noted the cooperation of the animal pharmaceutical industry for meeting its commitment to fully align all affected products with the GFI #213 recommendations. It also acknowledged the efforts of veterinary, animal producer and feed-industry organizations, as well as those of various local, state, and federal agencies.

“The success of this collaborative effort marks an important step forward for promoting antimicrobial stewardship in animals,” FDA added.

Of the 292 new animal drug applications initially affected by Guidance for Industry #213, 84 were completely withdrawn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. Another 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status.

Production claims — e.g., improved feed conversion or weight gain —were withdrawn from all medically important antimicrobials that included such indications for use

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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