The advisory committee calendar
Every peptide vote, its margin, and what is on the next docket. Kept current from the same dataset as the status tracker, so the two cannot drift apart.
Next: before 2027-02-28
Expected docket (5):
| Substance | Current status |
|---|---|
| GHK-Cu | Yes — non-injectable only, under interim enforcement discretion. The only one of the 19 that is. |
| Melanotan II | Off all lists — no enforcement discretion |
| Cathelicidin (LL-37) | Off all lists — no enforcement discretion |
| Dihexa acetate | Off all lists — no enforcement discretion |
| PEG-MGF | Off all lists — no enforcement discretion |
Held: 2026-07-23/24
Recommended six of seven for the 503A Bulks List; Emideltide rejected. FDA staff had recommended against all seven — all 14 substance forms — in identical language.
| Substance | Vote | Result | Where it stands now |
|---|---|---|---|
| BPC-157 Body Protection Compound | 8–6–1 for–against–abstain | Recommended | PCAC-recommended; FDA final action pending |
| KPV Lysine-Proline-Valine tripeptide | 8–6–1 for–against–abstain | Recommended | PCAC-recommended; FDA final action pending |
| TB-500 Thymosin beta-4 fragment | 8–6–1 for–against–abstain | Recommended | PCAC-recommended; FDA final action pending |
| MOTS-c Mitochondrial-derived peptide | 7–5–2 for–against–abstain | Recommended | PCAC-recommended; FDA final action pending |
| Emideltide (DSIP) Delta sleep-inducing peptide | 6–7–1 for–against–abstain | REJECTED | No — PCAC voted against (FDA final action pending) |
| Semax ACTH(4-10) analog | 8–5–1 for–against–abstain | Recommended | PCAC-recommended; FDA final action pending |
| Epitalon Epithalamin tetrapeptide | 7–4–1 for–against–abstain | Recommended | PCAC-recommended; FDA final action pending |
Margins verified across four legal and trade sources. Epitalon is reported 7–4–1 by three of them and 7–5 by a fourth; we carry the majority reading and record the discrepancy rather than hiding it.
What has to happen before any of this changes anything
- FDA decides. It may accept, reject or modify a recommendation. It is not bound by the vote, and its own reviewers opposed every substance on the July docket.
- A proposed rule publishes, with a public comment period. None has, as of 2026-09-06.
- A final rule adds the substance to the list at 21 C.F.R. § 216.23(a) — which today holds 6 substances and has never included a peptide.
- Compliant ingredient becomes available. Even a favorable final rule would not be enough. 21 U.S.C. § 353a also requires the active ingredient to come from an FDA-registered establishment with a valid certificate of analysis. Most peptide ingredient is made by facilities that are not FDA-registered.
What we watch for
- A Federal Register notice announcing the next meeting date and opening its docket — that is the first concrete signal, and it usually precedes the meeting by weeks.
- A proposed rule, which would be the first time any of this became legally operative rather than advisory.
- Any change to the interim category lists, since that is where enforcement discretion actually lives.
Our news watcher runs daily against the Federal Register and topic feeds; confirmed changes land in the changelog and on the tracker the same day.
Regulatory journalism, not medical or legal advice. Vote margins are reported across named legal and trade sources with a discrepancy noted where one exists. None of these peptides is an FDA-approved drug, and an advisory recommendation is not a finding that anything works. Corrections land in our changelog.