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# Guide on Bulk Drug Substances for Compounding
- URL: https://www.fdaweb.com/guide-on-bulk-drug-substances-for-compounding/
- Published: 2019-03-01T12:00:00.000Z
- Updated: 2026-09-15T01:09:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143502

FDA has issued a [final guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM602276.pdf?ref=fdaweb.com) on *Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act*. The document addresses the agency’s policies for developing a list of bulk drug substances that can be used in compounding. It also discusses FDA’s interpretation of “bulk drug substance for which there is a clinical need,” which is the statutory standard for compounding from bulk drug substances. The guidance also highlights criteria the agency generally intends to use to evaluate whether a bulk drug substance should be used by outsourcing compounding facilities.