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# Guidance on Compounding Bulk Drugs for Outsourcing Facilities
- URL: https://www.fdaweb.com/guidance-on-compounding-bulk-drugs-for-outsourcing-facilities/
- Published: 2016-06-10T12:00:00.000Z
- Updated: 2026-09-14T21:08:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135911

*Federal Register* Notice: FDA is making available guidance for industry entitled *Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act*. It describes FDA's interim regulatory policy on outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the FD&C Act. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-10/pdf/2016-13798.pdf?ref=fdaweb.com)