FDA GUIDANCE · DRAFTAugust 28, 2026

Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Draft

Issue date

August 28, 2026

This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

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