Based on feedback from member veterinarians and other stakeholders, the AVMA has compiled a list of key points to share with the FDA in our formal comments on the proposed FDA Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances.
The deadline for commenting on the draft guidance is October 15, 2020. The AVMA has been gathering input from members and others since the proposed guidance was released in November 2019.
AVMA’s formal comments to the FDA will include, among others, support for these provisions:
AVMA’s comments will express concern regarding these provisions:
A free webinar on AVMA Axon, Compounding: Understanding FDA draft guidance , shares more information about the draft guidance, including:
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. If you would like to submit your own feedback to the FDA, public comments on draft GFI #256 will be accepted until the October 15, 2020, deadline. To submit comments electronically, visit www.regulations.gov and type FDA-2018-D-4533 in the search box.
AVMA provides numerous 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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