October 27, 2023

APC requests transparency on new Cat 2 substances

In a letter this week to Gail Bormel, director of FDA’s Office of Compounding Quality and Compliance, APC called for transparency regarding the recent addition of substances to Category 2.

APC wants clarification on the process behind the FDA’s decision to include new substances in Category 2. The agency had cited “significant safety risks” as the basis for this categorization, but has not disclosed the methodology or, more importantly, specifics about the identified risks.

“More detail about FDA’s substance-specific safety concerns can assist APC and other groups in educating pharmacists, technicians, and other stakeholders about why the substances were added to Category 2 and the risks the agency sees as inherent in compounding with them,” the letter states.