On the second day of the FDA's Pharmacy Compounding Advisory Committee (PCAC) meeting in July 2026, the panel voted against recommending the peptide Emideltide (also known as DSIP, a delta sleep-inducing peptide) for inclusion on the 503A Bulk Drug Substances List, which governs which unapproved compounds compounding pharmacies may legally manufacture and dispense.
The vote was 7 to 6 against Emideltide, with one abstention, marking the advisory panel’s first pushback after having narrowly endorsed several other peptides on Day 1.
Seven panel members voted to keep restrictions in place, citing poor characterization of the bulk drug substance, low‑quality evidence of efficacy, and the availability of approved therapies for Emideltide’s proposed uses (opioid withdrawal, chronic insomnia, and narcolepsy). Panel member Todd Durham emphasized concerns about immunogenicity risks and lack of modern clinical data.
The vote followed the FDA’s own briefing documents, which recommended against adding Emideltide to the 503A list due to lack of human safety and efficacy data and potential for serious immune reactions. The committee’s advice is non-binding; the FDA will still issue a final rule, likely months later, before any compounding changes take effect.
Day 2 of the meeting continued with reviews of two other peptides, Semax and Epitalon, after Day 1’s controversial decisions to recommend BPC‑157, KPV, TB‑500, and MOTS‑c for broader compounding access despite FDA staff opposition.
Sources:
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