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US FDA

PCAC recommends six of seven nominated peptide bulk substances for the 503A Bulks List

PCAC voted on July 23-24, 2026 to recommend BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon for the 503A Bulks List, and voted 7-6 against emideltide (DSIP). All recommendations are non-binding; FDA rulemaking decides final list placement.

Status
Under Evaluation
Event type
PCAC Meeting

Primary source

Open source page

References

  1. 1.

    FDA. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee 2026.

    Accessed 2026-07-24.

    FDA meeting page for the July 23-24, 2026 PCAC review of BPC-157, KPV, TB-500, MOTs-C, emideltide/DSIP, Semax, and Epitalon bulk substances, including the uses evaluated for each, briefing documents, and docket FDA-2025-N-6895.

  2. 2.

    Other. FDA Panel Finds a Peptide It Doesn't Like 2026.

    Accessed 2026-07-24.

    MedPage Today meeting recap with final PCAC vote counts: BPC-157, KPV, TB-500, and MOTS-c recommended on July 23; epitalon recommended 7-5 and semax recommended 8-5 on July 24, one abstention each; emideltide voted down 7-6 with one abstention.

  3. 3.

    Other. FDA advisers vote against sleep peptide as they debate safety and health claims 2026.

    Accessed 2026-07-24.

    MarketWatch day-two report: emideltide (DSIP) fails 6-7 with one abstention, epitalon passes, member rationale quotes, and FDA staff concerns about 1980s-90s DSIP trial data.