Regulatory

FDA scientists' pre-meeting briefing documents for the July 23–24, 2026 PCAC hearing recommended against adding TB-500, BPC-157, and MOTS-C to the 503A Bulk Drug Substances List. The core finding: zero human clinical studies support the proposed uses for TB-500 and MOTS-C, while BPC-157's preclinical data cannot substitute for absent human efficacy evidence under the 503A standard.

Seven peptides — BPC-157 (free base and acetate), KPV, TB-500, MOTS-C, Emideltide (DSIP), Semax, and Epitalon — are formally scheduled for Pharmacy Compounding Advisory Committee (PCAC) review on July 23–24, 2026. A favorable committee recommendation initiates the rulemaking pathway toward the FDA's 503A Bulk Drug Substances List, ending each substance's Category 2 restriction status.