PeptideAmerica

US status

Pending

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 7–5. DSIP was rejected 6–7.

The votes are advisory, and they ran against the recommendations of FDA's own review staff. 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

BPC-157 PCAC-recommended · pending
Removed from Category 2 in April 2026; PCAC voted 8–6 to recommend 503A listing in July 2026; no FDA final rule.
MOTS-c PCAC-recommended · pending
Removed from Category 2 in April 2026; PCAC voted 7–5 to recommend 503A listing in July 2026; no FDA final rule.
TB-500 PCAC-recommended · pending
Removed from Category 2 in April 2026; PCAC voted 8–6 to recommend 503A listing in July 2026; no FDA final rule.
KPV PCAC-recommended · pending
Removed from Category 2 in April 2026; PCAC voted 8–6 to recommend 503A listing in July 2026; no FDA final rule.
Semax PCAC-recommended · pending
Removed from Category 2 in April 2026; PCAC voted 8–5 to recommend 503A listing in July 2026; no FDA final rule.
Epitalon PCAC-recommended · pending
Removed from Category 2 in April 2026; PCAC voted 7–5 to recommend 503A listing in July 2026; no FDA final rule.

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