Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities August 2026

GUIDANCE DOCUMENT

Submit Comments by 11/27/2026

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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2018-D-4533

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• Docket Number: FDA-2018-D-4533
• Issued by: Center for Veterinary Medicine

This draft guidance, when finalized, will describe the Food and Drug Administration’s (FDA) enforcement policy regarding the compounding of animal drugs from bulk drug substances (also known as Active Pharmaceutical Ingredients (APIs)) when those drug products are compounded in accordance with current good manufacturing practice (CGMP) in facilities registered with FDA under section 503B(b) or section 510(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereinafter “federally-registered facilities”).

This draft guidance does not cover animal drugs compounded for use in investigations of new animal drugs, animal drugs compounded by a pharmacy that is not federally-registered, or animal drugs compounded from FDA-approved animal or human drugs.

This draft guidance, when finalized, will be combined with GFI #256, “Compounding Animal Drugs from Bulk Drug Substances,” which describes FDA’s enforcement priorities for animal drugs compounded from bulk drug substances (BDS) by or under the direct supervision of pharmacists in state-licensed pharmacies or federal government facilities.6 FDA is adding this guidance to provide recommendations for federally-registered facilities that operate in compliance with state laws and regulations governing drugs, pharmacy, and veterinary medicine but that may not be state-licensed pharmacies (e.g., the state has a different license for outsourcing facilities). This guidance extends FDA’s enforcement discretion policies to additional types of facilities, but notes FDA generally would not intend to exercise enforcement discretion for CGMP violations at these federally-registered facilities. Federally-registered facilities manufacture or compound other drugs (such as human drugs or approved animal drugs) that are not subject to enforcement discretion policies. Applying inconsistent quality standards for different drugs made in the same federally-registered facility could complicate FDA inspections, confuse registered establishments about how and when to apply certain facility-wide CGMP requirements for human drugs or approved animal drugs manufactured at federally-registered facilities, and could confuse consumers about the expected quality of a drug they purchase from a registered establishment.

If a federally-registered outsourcing facility is also a state-licensed pharmacy and wishes to follow the recommendations in either GFI #256 and/or this guidance, it should ensure complete segregation of CGMP and non-CGMP operations (including following all relevant guidance for outsourcing facilities7). As outsourcing facilities are widely-understood to produce drugs under CGMP, the facility should also ensure it labels any drugs not made in accordance with CGMP in a manner that is not false or misleading (e.g., by stating the drug was not compounded under CGMP on the label or by distributing the drug under a different name than used for the facility’s 503B registration).

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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