Overview
- The FDA’s Pharmacy Compounding Advisory Committee voted narrowly on Thursday, July 23, to recommend adding BPC‑157, KPV and TB‑500 by an 8–6 vote with one abstention and MOTS‑C by a 7–5 vote with two abstentions.
- Career FDA scientists told the panel these peptides lack sufficient human safety and efficacy data and urged against allowing compounding at this time.
- Several outside advisers on the committee have financial ties to peptide businesses, which critics say raised conflict‑of‑interest concerns during the meeting.
- If the FDA accepts the recommendations the bulks list would allow licensed compounding pharmacies to mix these substances into prescription medicines but would not mean the peptides are FDA‑approved drugs.
- Advocates say regulated compounding could reduce dangerous gray‑market sourcing, while experts warn it may be mistaken for agency approval and that a final FDA decision could take several months after staff review and public comment.