Independent · evidence-checked · not affiliated with the FDA

Seven peptides. Two days. One vote that moves a billion-dollar market.

On July 23–24, 2026 an FDA advisory committee recommended six of seven widely-used peptides for licensed compounding — a non-binding vote the FDA has not yet acted on. We track the legal status of each — and tell you plainly what the science does and doesn’t show.

EVENT  FDA PCAC · 23–24 Jul 2026DOCKET  FDA-2025-N-6895SCOPE  503A Bulks ListLAST UPDATED  13 Sep 2026
Latest developments
All updates →
  • Sep 5 — Six weeks on, no FDA action: no proposed rule, no statement. Access timelines revised to 2027 at the earliest. Read →
  • Aug 5 — FDA approves the first drug for narcolepsy type 1, twelve days after the committee turned down DSIP for that indication. Read →
  • Jul 24 — Day 2: Epitalon (7–4) and Semax (8–5) recommended; Emideltide rejected 6–7. Six of seven clear the committee. Read →
  • Jul 23 — Day 1: the committee recommends all four — BPC-157, KPV, TB-500 (8–6 each) and MOTS-c (7–5) — against the FDA staff review. Read →
  • Jul 17 — Pre-vote check: the July 23–24 meeting, agenda, and all seven FDA briefing documents are confirmed. Read →
  • Jul 1 — FDA review staff recommend against all seven peptides, citing limited human evidence — a public split with HHS leadership. Read →
  • Jun 29 — Advisory committee seated (14 members); about half have peptide-industry ties, drawing conflict-of-interest scrutiny.
The board

Where each peptide stands today

In April 2026 these seven — among a dozen peptides — were removed from FDA Category 2 — but not moved to the approved Category 1 list. None is FDA-approved; none is yet legal to compound.

Was Category 2 (2023) Removed Apr 2026 · under PCAC review Compoundable (pending)
BPC-157 Day 1
Not FDA-approved · read the evidence →
Use FDA is reviewingUlcerative colitis (UC)
Cat 2PCACCompoundable
Recommended · Jul 23, 2026
KPV Day 1
Not FDA-approved · read the evidence →
Use FDA is reviewingWound healing & inflammatory conditions
Cat 2PCACCompoundable
Recommended · Jul 23, 2026
TB-500 Day 1
Not FDA-approved · read the evidence →
Use FDA is reviewingWound healing
Cat 2PCACCompoundable
Recommended · Jul 23, 2026
MOTS-c Day 1
Not FDA-approved · read the evidence →
Use FDA is reviewingObesity & osteoporosis
Cat 2PCACCompoundable
Recommended · Jul 23, 2026
Emideltide DSIP · Day 2
Not FDA-approved · read the evidence →
Use FDA is reviewingOpioid withdrawal, chronic insomnia, narcolepsy
Cat 2PCACCompoundable
Not recommended · Jul 24, 2026
Semax Day 2
Not FDA-approved · read the evidence →
Use FDA is reviewingCerebral ischemia, migraine, trigeminal neuralgia
Cat 2PCACCompoundable
Recommended · Jul 24, 2026
Epitalon Day 2
Not FDA-approved · read the evidence →
Use FDA is reviewingInsomnia
Cat 2PCACCompoundable
Recommended · Jul 24, 2026

Status nuance: the April 15, 2026 removal from Category 2 happened because the nominations were withdrawn — not because the FDA found these peptides safe. Removal does not authorize compounding (that needs Category 1, a USP monograph, or approval) and does not grant enforcement discretion. The July vote is the first formal step.

A separate PCAC meeting before the end of February 2027 will review five more: Cathelicidin LL-37, Dihexa acetate, GHK-Cu (injectable), PEG-MGF (pegylated MGF), and Melanotan II. Non-injectable GHK-Cu sits in Category 1 and may be compounded under the FDA’s interim policy; only the injectable route is outside it.

New here? How US peptide regulation actually works →

THE ROAD TO THE VOTE
Apr ’26
Removed from Category 2 (limbo — not yet compoundable)
Jun 29
FDA briefing materials released — review staff recommend against
Jun 30
Deadline to request to speak at the hearing
Jul 9
Public comments by this date reach the committee
Jul 22
Public docket closes (regulations.gov, 11:59 ET)
Jul 23
Day 1 vote — BPC-157, KPV, TB-500, MOTS-c
Jul 24
Day 2 vote — DSIP, Semax, Epitalon
Next
FDA decides whether to open rulemaking — pending; no proposed rule as of Sep 13

Recommendations are non-binding. Where favorable, FDA rulemaking would follow; realistic pharmacy access is 2027 at the earliest — no proposed rule as of September 2026. Every vote was close: 8–6 with one abstention for BPC-157, KPV and TB-500; 7–5 with two abstentions for MOTS-c; 7–4 for Epitalon and 8–5 for Semax. Emideltide (DSIP) failed 6–7 — the only substance the committee declined to recommend. The FDA announced eight new members on 29 June 2026, shortly before the meeting. Health Affairs later put the panel at 11 standing voting members plus those eight temporary ones, with between 12 and 15 voting on each peptide; the FDA has not published that breakdown itself. Roughly half of the seated members have peptide-industry ties, which has drawn conflict-of-interest scrutiny.

The Compounding Brief

Know the moment a peptide’s legal status changes.

We email when a peptide’s status actually moves — committee votes, briefing documents, final rules — plus the occasional licensed-access update. Plain-English, evidence-first. No hype, no filler.

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HOW WE WORK

Methodology & sourcing

Every status here is tied to a primary source — the FDA advisory committee calendar, the Federal Register notice (docket FDA-2025-N-6895), the FDA’s interim 503A bulk-substances list, and ClinicalTrials.gov. We state an evidence grade for each peptide honestly: where human data is thin or absent, we say so, and where sources conflict (as with CJC-1295 and ipamorelin’s current category), we flag it rather than pick a side. We do not publish dosing, reconstitution, or sourcing information, and we do not link to “research-use” sellers.

Health content is researched, cited, and dated. A named licensed-clinician review is being added; until it is, pages are presented as editorial and are not described as medically reviewed. Funding and partner relationships are disclosed; corrections are logged publicly.