Peptides have become one of the most closely scrutinized categories in modern therapeutics. Once limited to select endocrine and metabolic uses, they now occupy a rapidly expanding space in chronic disease management, wellness medicine, and compounding practice. At the same time, FDA oversight of peptides has evolved significantly, creating new compliance challenges and access concerns for providers and patients. This presentation examines the FDA’s historical treatment of peptide-based products and explains how statutory, regulatory, and policy developments have shaped today’s landscape. Attendees will gain clarity on distinctions among FDA-approved peptide drugs, biologics, compounded preparations under Sections 503A and 503B, and products marketed as research-use-only or dietary supplements. The session will explore current enforcement trends, manufacturing and quality standards, and the interplay between federal oversight and state pharmacy regulation. Importantly, we will assess how regulatory decisions affect patient access, affordability, and continuity of care—particularly when approved alternatives are limited or cost-prohibitive. Participants will leave with a clear, balanced understanding of how peptide regulation has evolved, where it stands today, and the key considerations for navigating this rapidly changing environment.

Speaker:
Marc N. Wagner

Please note there is a cost to attend. CE credits available.