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Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.
- Document type
- Notice
- Federal Register document number
- 2026-17580
- Published
- Aug 28, 2026
- Action
- Notice of availability.
- Docket
- FDA-2018-D-4533
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by November 27, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- GMP / manufacturing
Source: Federal Register API, document 2026-17580. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.