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# Bulk Drug Use in Compounding Draft Guide
- URL: https://www.fdaweb.com/bulk-drug-use-in-compounding-draft-guide/
- Published: 2018-03-26T12:00:00.000Z
- Updated: 2026-09-14T23:55:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141061

*Federal Register* notice: FDA has made available a draft guidance entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document describes policies that FDA proposes to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in drug compounding. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-03-26/pdf/2018-06046.pdf?ref=fdaweb.com).