December 8, 2023

FDA to end bulk drug categories

This week, FDA published a new draft guidance titled  “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.” Comments are due January 8. 

If finalized as presented, FDA will no longer categorize items for the bulks drug list prior to evaluating them for inclusion. For substances nominated before the guidance is finalized, FDA does not intend to take action against a compounder using that substance as long as it appears in current Category 1, the manufacturer of the bulk substance is registered, and a COA is present.