Draft guidance for industry number 256B sets out when the agency does not generally intend to act against compounding of animal drug products from bulk drug substances at federally registered facilities.
Washington, 28 August 2026 — The Food and Drug Administration announced the availability of a draft guidance for industry, numbered 256B, entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities".
The notice states that the draft guidance, when finalised, will describe the agency’s current thinking on the circumstances in which it generally does not intend to take action against the compounding of animal drug products from bulk drug substances, where that compounding is done in accordance with Current Good Manufacturing Practice at drug production facilities registered with the agency. The same document also opens a proposed information collection for comment.
Source documents
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Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Identifier
- Federal Register document 2026-17580
- As the record states
- The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding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 number
- 2026-17580