FDA grants AVMA request to extend comments on compounding from bulk drugs

Published on February 14, 2020
Gloved hands hold a mortar and pestle with white substance inside.

Comment deadline for draft GFI #256 is delayed

The FDA agreed Friday to allow an additional 120 days for public review and commenting on its latest proposal to regulate compounding. Granting a request made by the AVMA on February 3, FDA officials announced they would receive comments on draft Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances, until June 17.

Why is the extension needed?

When the draft guidance was released in November, the AVMA began seeking feedback from members and other veterinary associations. The responses we received indicated several areas of confusion, and the AVMA requested an extension of the comment period to allow more time to clarify those areas and craft an informed veterinary response.

We’re pleased by the FDA’s positive response to our request. We’ll continue working with the agency to clarify its guidance while also gathering stakeholder input to understand the veterinary community’s questions and concerns.

Make your voice heard; input sought by April 20

The FDA announcement allows more time for AVMA members to review the proposed guidance, ask questions about it, and provide input. The AVMA will use this feedback to inform our advocacy on this issue and submit additional response to the FDA.

Here’s how AVMA members can make your voice heard in our collective response to the FDA:

  • Review AVMA’s summary of the draft proposal.
  • See the information provided by the FDA Center for Veterinary Medicine – including an explanatory webinar, transcript, and slides.
  • Read the AVMA’s February 3 letter to the FDA, which outlines areas needing clarification.
  • Send questions and comments to compoundingatavma [dot] org no later than April 20 to inform our continued dialogue with the FDA.

Members guide the AVMA’s work. Your input will help the AVMA ensure that the veterinary profession’s unique compounding needs are understood by the FDA.

Comments

Guidance for Industry (GFI) #256, Compounding Animal Drugs from

veterinarians need to have access to compounding pharmacy's in order to keep practicing quality care.
The FDA does not need to further regulate an area that is already regulated enough.

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