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GUIDANCE DOCUMENT

Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide; Guidance for Industry May 2019

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2019-D-2011
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help small businesses better understand and comply with the final rule establishing the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) (final rule or 503A Bulks List Final Rule). On February 19, 2019 (84 FR 4696), FDA published a final rule that establishes FDA’s criteria for evaluating bulk drug substances for inclusion on the list of bulk drug substances that may be used to compound drug products under section 503A of the FD&C Act (the 503A Bulks List or the list) and that places six substances on the list. The final rule, entitled “List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act,” also identifies four substances that were considered for and not included on the list.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-2011.

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