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 decides whether seven widely-used peptides move toward licensed compounding pharmacies. 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  24 Jul 2026
Latest developments
All updates →
  • 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, GHK-Cu (injectable), PEG-MGF (pegylated MGF), and Melanotan II. Non-injectable GHK-Cu was separately removed from Category 1.

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

Recommendations are non-binding. If favorable, FDA rulemaking follows; realistic pharmacy access is late 2026–Q1 2027. 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. Voting members were added shortly before the meeting; several 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.