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GUIDANCE DOCUMENT

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act January 2025

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2015-D-3517
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”  This guidance describes FDA’s interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.

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All written comments should be identified with this document's docket number: FDA-2015-D-3517.

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