FDA releases final guidance on compounding using bulk drug substances

June 9 , 2016
The FDA released its final guidance titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The AADA asked the FDA to finalize its proposal to not take enforcement action against bulk substances, such as canatharidin, that FDA had approved for inclusion on the bulk substance list but additions had not been finalized through notice-and-comment rulemaking in the Federal Register. Read the AADA's comment letter.

In the final guidance, the FDA stated that it understood that the administrative process could be causing “unnecessary and inappropriate disruptions in patient care” and finalized its non-enforcement policy where the bulk drug substance nomination included adequate information for FDA evaluation and the substance does not appear to present significant safety risks.