Federal Register #FDA-2018-D-4533

FDA Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances under CGMP

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has released a draft guidance for industry regarding compounding animal drugs from bulk drug substances under Current Good Manufacturing Practice (CGMP) in federally-registered facilities. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are mentioned in this notice - Products/Services Requested: - No procurement of products or services; the notice is for draft guidance release - Unique or Notable Requirements: - Guidance clarifies FDA's regulatory approach to compounding animal drugs from bulk drug substances - Focuses on compliance with CGMP at FDA-registered drug production facilities - Addresses prescribing to groups of animals and use of bulk drug substances for nonfood-producing animals and wildlife - Invites public comment to inform final guidance - Technical Information: - Outlines circumstances where FDA does not intend to take regulatory action if compounding is done under CGMP - Applies to compounding for animal drugs, not human drugs - No procurement activity, contract, or solicitation is associated with this notice

Description

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry titled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This guidance outlines FDA's current thinking on when the agency generally does not intend to take action against the compounding of animal drug products from bulk drug substances, provided it is done in compliance with Current Good Manufacturing Practice (CGMP) at FDA-registered drug production facilities. The draft guidance aims to clarify regulatory expectations for animal drug compounding and invites public comments by November 27, 2026. It also addresses issues such as prescribing to groups of animals and the use of certain bulk drug substances for nonfood-producing animals and wildlife species.

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