US status

Pending

By Peptide America · Publisher · Reviewed August 2026

In April 2026 the FDA removed twelve peptides from Category 2 of its interim 503A bulks list, the category for substances with identified safety concerns, without adding them to Category 1; the removal ended explicit prohibitions and authorized nothing. On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee reviewed seven of the twelve and voted to recommend six for the section 503A list: BPC-157 and KPV and TB-500 by 8–6, MOTS-c by 7–5, Semax by 8–5, and Epitalon by 7–4. DSIP was rejected 6–7.

Those seven tallies are reported figures, and this page states so wherever it prints one. The FDA has published no minutes, no transcript and no vote summary for the meeting; its meeting page, current as of August 6, 2026 and re-read on August 31, 2026, carries briefing documents, an agenda, a roster and presentations, and no record of how anyone voted. The numbers above are taken from two named accounts that agree substance by substance — McDermott Will & Schulte's report of July 27, 2026 and LumaLex Law's of July 25, 2026 — and the vote ledger sets out that provenance in full. The committee's December 2024 votes, by contrast, are cited on this site to FDA's own Final Summary Minutes; when the equivalent document issues for July 2026, these pages will be recited to it.

The votes are advisory, and they ran against the recommendations of FDA's own review staff, which had proposed that none of the substances be listed. Rulemaking must finish before any of the six may be lawfully compounded, and as of August 2026 none may be. A further PCAC meeting, covering five more peptides, is announced for early 2027.

The market reads the votes as a signal of where supply is heading. This index records the votes, the dates, and the unchanged legal position, and each indexed molecule below carries its votes and dates; monographs add an FDA-final-action entry that remains empty until a rule issues.

Molecules holding this status

MoleculeClassUS statusPosition
BPC-157Body Protection Compound 157; pentadecapeptide BPCRepair peptidesPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
MOTS-cMitochondrialPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
TB-500Thymosin beta-4 fragmentRepair peptidesPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
KPVLysine-proline-valine; alpha-MSH fragmentRepair peptidesPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
SemaxNeuropeptidesPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
EpitalonEpithalon; AEDG tetrapeptideLongevity peptidesPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.

The research-only page covers the removed peptides that never reached the committee, where even an advisory vote is absent.

Elsewhere in this index

Evidence reviews

Reference tables

Definitions