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# Final Guide on Compounding Bulks List
- URL: https://www.fdaweb.com/final-guide-on-compounding-bulks-list/
- Published: 2019-05-24T12:00:00.000Z
- Updated: 2026-09-15T01:28:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144188

*Federal Register* notice: FDA has made available a [final guidance](https://www.fda.gov/media/126110/download?ref=fdaweb.com) entitled “Section 503A Bulks List Final Rule Questions and Answers.” The document 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. On 2/19, FDA published a final rule that established criteria for evaluating bulk drug substances for inclusion on the list, and that placed six substances on the list. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-24/pdf/2019-10953.pdf?ref=fdaweb.com).