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# Interim Compounding with Bulk Substances Policy
- URL: https://www.fdaweb.com/interim-compounding-with-bulk-substances-policy/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145375

FDA has issued a guidance, *Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act*, with the agency’s interim regulatory policy concerning compounding by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act using bulk drug substances. The [document](https://www.fda.gov/media/94402/download?utm%5Fcampaign=Interim%20Policy%20on%20Compounding%20Drugs%20Using%20Bulk%20Drug%20Substances&utm%5Fmedium=email&utm%5Fsource=Eloqua) says Section 503B includes certain restrictions on the bulk drug substances that outsourcing facilities can use in compounding, and directs FDA to develop a list of bulk drug substances that can be used in compounding under that section.

FDA is developing the 503B bulks list and the guidance describes FDA’s interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while the list is being developed, the agency says.

The guidance describes three categories of bulk drug substances nominated by the public for use in compounding and the regulatory action FDA intends to apply to each.