PCAC backed six of seven peptides in July. Two months later, FDA has not acted

The seven votes

Each compound was put to the committee as two questions, one for the free base and one for the acetate salt. Every published account reports a single result per compound; none reports the two forms splitting. Published reports agree on every tally except epitalon's. Hyman, Phelps & McNamara's FDA Law Blog and McDermott report 7–4; RAPS reports 7–5; all three give one abstention. FDA has not posted minutes, and we will record the official count when it does. The outcome is not in dispute.

Why the committee and FDA's reviewers split

FDA's briefing documents made the same case against all seven: the substances are not well characterised, the information needed to judge immunogenicity risk is missing, the evidence of effectiveness for the uses under review is insufficient, and approved treatments already exist for those uses. Our PCAC hub sets out where the seven files differ.

Members who voted yes weighed those gaps differently. Several said they were applying the 503A criteria rather than drug-approval standards and would leave individual treatment decisions to prescribers and pharmacists; others argued that the realistic alternative to a compounded peptide is a gray-market one, not none at all. Members who voted no pointed to the gaps in safety and effectiveness data, and to the risk that listing would suggest these substances had been reviewed to a standard they have not met. On emideltide the dissenters carried the vote, citing weak efficacy evidence, poor characterisation, approved alternatives and a complicated dosing regimen.

The make-up of the panel drew scrutiny. FDA added temporary voting members for this meeting, and Time reported that the yes votes came largely from members who represent or advise telehealth companies. An HHS spokesperson said every member had gone through the ethics review required of all FDA advisory committee members.

What FDA has done since

Nothing that changes any compound's status. We checked on September 25, 2026:

• FDA's list of substances nominated for 503A compounding — where a move into Category 1 would show up first — is still dated May 14, 2026, and none of the six is in Category 1. (source)
• FDA's meeting page was last updated on August 6. It lists the briefing documents, voting questions, roster and presentations and links video of both days. It carries no minutes, and nothing on what FDA intends to do. (source)
• We found no proposed rule to add any of the six to the list, and legal commentary published as late as September 17 still describes further FDA action as the next required step. (source)

Three paths remain open. FDA can begin notice-and-comment rulemaking to amend the list at 21 CFR 216.23, which means a proposed rule and a public comment period before anything is final. It can place some or all of the six in Category 1 in the meantime — the interim policy's “under evaluation” category, where FDA generally does not act against pharmacies compounding a substance — which some lawyers expect and others caution a favourable vote does not guarantee. Or it can decline: FDA says it generally follows its advisory committees but is not legally bound by them.

What the vote does not change

• It is not approval. The 503A Bulks List is a compounding pathway, not a finding that a substance is safe or effective. None of the six has an approved use or an established dose.
• It does not touch research-use-only material, which sits under an entirely separate set of rules.
• It does not affect anti-doping status. The World Anti-Doping Agency's Prohibited List is independent of FDA; our regulatory tracker shows each compound's classification.

What comes next

For the six recommended in July, the things to watch are FDA's category list and the Federal Register. A move into Category 1 would appear on the list; a proposed rule would open a public comment period before anything became final.

A second PCAC meeting on five more peptides — cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II and pegylated mechano growth factor (PEG-MGF) — is still due before the end of February 2027. As of September 25, 2026, FDA's page for it gives no date: it says the time and location will be scheduled in the coming months. We will cover the briefing documents when they are released, as we did for July.

Read more on Grey Peptides

Each compound has its own page with the vote and FDA's briefing: BPC-157, KPV, TB-500, MOTS-c, Emideltide (DSIP), Semax, Epitalon. The PCAC hub has the full explainer, the regulatory tracker has every compound's status in one table, and our July 16 preview is kept as it was published.