Presented By: Texas Pharmacy Association (TPA)
About the Course
Pharmacy compounding remains one of the most closely watched areas of FDA enforcement, particularly as compounded GLP-1s and peptides continue to draw regulatory and manufacturer attention. Compounding pharmacies and the telehealth and business relationships built around them face an increasingly complex mix of statutory limits, agency guidance, and active litigation.
Jesse Dresser will walk attendees through the legal framework governing compounding under Section 503A, the shifting enforcement landscape for GLP-1 and peptide products, and the compliance risks emerging from telehealth and third-party payment arrangements. The session draws on recent FDA warning letters, manufacturer litigation, and outcomes from the July 2026 Pharmacy Compounding Advisory Committee meeting to give attendees a current, practical view of the compounding landscape.
During this program, attendees will:
- Review the legal framework governing pharmacy compounding under Section 503A, including key limitations on compounded products
- Assess the current regulatory landscape for GLP-1 compounding, including FDA’s “essentially a copy” guidance, manufacturer litigation, and warning letter trends
- Evaluate legal developments affecting peptide compounding, including Category 1 and Category 2 substances, Research Use Only ingredients, and the July 2026 Pharmacy Compounding Advisory Committee meeting
- Identify compliance risks tied to telehealth relationships, third-party payment arrangements, and other emerging pharmacy compounding business models
