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# FDA Sets Bulk Substance Compounding Policy
- URL: https://www.fdaweb.com/fda-sets-bulk-substance-compounding-policy/
- Published: 2023-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:17:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155927

FDA has published a draft guidance, *Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act*, stating that it does not intend to take regulatory action for compounding drug products under Section 503A using a bulk drug substance when an applicable U.S. Pharmacopeia or National Formulary monograph for the substance does not exist and the substance is not a component of an FDA-approved product if, among other conditions, the bulk drug substance appears on Category 1 on the FDA Web site. The [document](https://www.fda.gov/media/174453/download?ref=fdaweb.com) says FDA is developing a list of bulk drug substances required under Section 503A and the interim regulatory policy is effective while the list is being developed.