A Critical Look at FDA’s Bulk Substances Interim Guidelines for Compounding Facilities

In 2023, the Food and Drug Administration (FDA or agency) issued a draft guidance outlining its current views on the use of bulk drug substances by compounding facilities pursuant to Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The draft guidances represent a critical pivot point from FDA’s previous approach and is poised to restrict the use of non-listed bulk drug substances as the agency will no longer categorize new nominations to the bulk drug list. This could impose significant supply pressures on compounding facilities and potentially affect the availability of those facilities to address drug shortages for critical drugs, such as semiglutides.

This presentation will dissect the proposed changes, exploring their implications for compounding facilities’ operations, compliance strategies based on FDA's current enforcement policies, and the broader landscape of drug compounding.