Statement from the Alliance for Pharmacy Compounding on FDA Proposed Rule Regarding 503B Bulks List

The Alliance for Pharmacy Compounding is reviewing the FDA’s proposed rule addressing the 503B Bulks List, including the agency’s proposal not to include liraglutide, semaglutide, and tirzepatide.

At present, this proposal does not change the status quo. Under existing law, compounding with these substances by outsourcing facilities is already limited and has primarily occurred in the context of drug shortages. During those shortages, FDA-registered outsourcing facilities played an important role in helping meet patient needs when commercially available options were unavailable.

APC believes it is important that any final policy fully reflect both the statutory framework established by Congress and the practical realities of patient care. Compounding has long served as a critical, complementary component of the healthcare system, particularly in times of supply disruption.

We will review the proposal and provide comments to the agency.