FDA Bulks Drug Substances List Updated May 14, 2026 — Ongoing Compounding-Status Rolling Updates Ahead of July 23-24 PCAC
The FDA updated its Section 503A bulks drug substances list on May 14, 2026, continuing the rolling-status changes leading into the July 23-24 PCAC meeting that will evaluate seven peptides (BPC-157, KPV, TB-500, MOTs-C on Day 1; Emideltide/DSIP, Semax, Epitalon on Day 2) for potential 503A-bulks-list inclusion. The April 30 503B bulks-list proposal (closing June 29) is moving in parallel toward effectively ending large-scale 503B compounding of semaglutide, tirzepatide, and liraglutide. The combined regulatory cycle through July 24 will reshape the compounding-pharmacy economy for the next 2-3 years and determine which research peptides remain accessible through licensed channels.