Overview
- The FDA, which unveiled the plan Thursday, proposed removing semaglutide, tirzepatide, and liraglutide from the 503B bulks list used for large‑batch compounding.
- 503B outsourcing facilities make drugs in bulk for clinics and hospitals, while 503A pharmacies compound per‑patient prescriptions, and the proposal targets only the 503B pathway.
- The agency opened a public comment window through June 29, 2026, and a final decision would sharply curb mass production of compounded GLP‑1s unless a shortage exists.
- FDA officials said prior shortages that fueled compounding have ended for tirzepatide (December 2024) and semaglutide (February 2025), with liraglutide still listed with limited availability.
- Regulators have escalated enforcement in recent months with guidance to halt compounding once shortages end, 30 warning letters to telehealth sellers, and a citation over sterility lapses, even as compounded GLP‑1s made up as much as 30% of supply in 2024.