American Veterinary Medical Association Asks FDA to Delay GFI #256 Comment Period

On February 3, 2020, the American Veterinary Medical Association sent this letter to the FDA:

RE: Docket No. FDA-2018-D-4533; Compounding Animal Drugs From Bulk Drug Substances; Draft
Guidance for Industry; Availability

Mr. Eric Nelson
Director, Division of Compliance (HFV-230)
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Pl.
Rockville, MD 20855

Dear Mr. Nelson:

The American Veterinary Medical Association respectfully requests at least a 120-day extension to the
comment period for Docket ID: FDA-2018-D-4533; Compounding Animal Drugs From Bulk Drug
Substances; Draft Guidance for Industry; Availability.

Since the release of draft Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug
Substances, the AVMA has been actively seeking feedback from its members and other veterinary
associations. The responses we have received indicate there are several areas of draft GFI # 256 where
further information is needed to gauge the impact of the draft guidance on the veterinary profession.
Two broad areas of confusion include the intersections of draft GFI # 256 with USP chapters and
monographs and its interpretation in the context of existing CVM Compliance Policy Guides (CPG).

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