What changed
On July 23-24, 2026, the Pharmacy Compounding Advisory Committee (PCAC) reviewed seven peptide bulk substances nominated for the 503A Bulks List, the list that determines what a compounding pharmacy may legally prepare against an individual prescription. On day one, the committee recommended BPC-157 (evaluated for ulcerative colitis), KPV (wound healing and inflammatory conditions), and TB-500 (wound healing), each by a vote of 8-6 with one abstention, and MOTS-c (obesity and osteoporosis) by 7-5 with two abstentions. On day two, it recommended Semax (evaluated for cerebral ischemia, migraine, and trigeminal neuralgia) by 8-5 with one abstention and Epitalon (insomnia) by 7-5 with one abstention, and it voted 7-6 against emideltide, also called DSIP (opioid withdrawal, chronic insomnia, and narcolepsy), with one abstention. Every favorable vote went against FDA staff briefing documents, which had proposed adding none of the seven. These votes are advisory only: they do not approve any drug, indication, dose, or product, and they do not make compounding legal today. For a recommended substance to join the 503A list, FDA must complete formal rulemaking, including a proposed rule and a public comment period, a process that has historically taken a year or more. For emideltide, the negative recommendation makes near-term inclusion unlikely, although a future nomination with stronger evidence can be reconsidered. The committee also announced that five more peptides removed from Category 2 in April 2026 (LL-37, injectable GHK-Cu, Dihexa, Melanotan II, and PEG-MGF) are expected at a separate PCAC meeting in early 2027. Peptides Media has updated the regulatory tracker and the affected peptide records with the vote outcomes.
Affected pages
Sources
- 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.
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.
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.
- 4.
Other. FDA advisory committee votes to add popular peptide BPC-157 to drug compounding list 2026.
Accessed 2026-07-24.
ABC News report on the July 23, 2026 BPC-157 vote (8-6 with one abstention), the non-binding nature of the recommendation, and FDA staff data-quality concerns.
- 5.
Other. In win for RFK Jr., FDA advisory panel narrowly votes to allow compounding of unapproved peptides 2026.
Accessed 2026-07-24.
STAT day-one report on the July 23, 2026 PCAC votes recommending BPC-157 and KPV for 503A compounding over FDA staff objections.
- 6.
Other. FDA Panel Votes to Loosen Restrictions for Four Peptides 2026.
Accessed 2026-07-24.
Pharmaceutical Executive day-one recap: BPC-157, KPV, and TB-500 each pass 8-6 with one abstention; MOTS-c passes 7-5 with two abstentions; includes member quotes on both sides.