FDA extends comment deadline on compounding guidance

Published on June 11, 2020
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Action follows AVMA request for more review time

Compounding

Veterinary professionals and the public have more time to review proposed new guidance on veterinary drug compounding from bulk substances, the U.S. Food and Drug Administration (FDA) announced Thursday. 

The deadline for commenting on FDA Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances has been extended to October 15, 2020.

The FDA previously had set a June 15 comment deadline, but the AVMA requested more time for veterinarians to review the proposal thoroughly. AVMA asked for an extension of at least 120 days, noting that COVID-19 has required veterinarians to refocus attention on how best to continue serving patients and clients, leaving limited time to consider the compounding proposal. 

This is the second time the deadline has been extended. Comments originally were to be due on February 18, 2020.

Powered by you: Send comments to AVMA

Because drug compounding is a critical tool for veterinarians, the AVMA works closely with the FDA, lawmakers, and other organizations to ensure that veterinary voices are heard in rulemaking. In this role, the Association is collecting comment from AVMA members to inform a collective response to the FDA regarding the draft guidance.

Member comments are due to the AVMA by August 15, 2020, and should be emailed to compoundingatavma [dot] org

Learn more about the proposed guidance

Numerous questions emerged about the proposed FDA guidance after the agency released it in November 2019. A free webinar on AVMA Axon, Compounding: Understanding FDA draft guidance, shares more information about the proposal:

  • Why the FDA can’t assure the safety, effectiveness, or quality of bulk drug substances  
  • How the draft guidance attempts to balance the risks of animal drugs compounded from bulk substances when no FDA-approved drug is available for treatment 
  • Policies included in the draft guidance and how they impact veterinary practice

The webinar gives important background to help veterinarians provide informed feedback on the proposed guidance. AVMA also has prepared a summary of the proposal’s key points.

More compounding resources

AVMA’s work on behalf of members and the profession also includes developing resources to help veterinarians navigate the fine points of prescribing and using compounded medications. Visit avma.org/Compounding for definitions, answers to frequently asked questions, AVMA policies on compounding, and other tools.
 

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