Jul 24, 2026BoardMeeting
BoardPharmacy Compounding Advisory Committee Advisory Committee Meeting
The meeting focused on the evaluation of specific bulk drug substances, including Emodelide, Semox, and Epitoilon related substances, for potential inclusion on the 503A bulks list. The committee reviewed the FDA's evaluation criteria, covering physical and chemical characterization, safety, effectiveness, and historical use. Discussions also addressed the role of real-world evidence and clarified alternative pathways for medical access, such as expanded access programs, IND-based clinical trials, and orphan drug designation.