U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;
  1. Regulatory Information

GUIDANCE DOCUMENT

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

Final Level 1 Guidance

Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;

Docket Number:
2019-10953
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.


Submit Comments

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

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-10953 .