PCAC Watch · Peptide Reclassification · 2026

The peptide reclassification, tracked — in one place.

A physician-maintained page following the July 23–24, 2026 FDA compounding review that will decide the durable legal status of several peptides we prescribe. Updated when the facts change.

Maintained by Joshua Hare, DO · Last updated 2026-06-27

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Days to PCAC

Jul 9

Advance-comment cutoff

Jul 22

Comment window closes

Jul 23–24

PCAC meeting

Early 2027

Second PCAC meeting

Our public comment: filed · Comment window: open through Jul 22 · Patient posture: unchanged

Why this page exists

The legal picture is moving. We track it openly.

The April 23, 2026 reclassification restored legal compounding of several peptides through licensed 503A pharmacies. The July 23–24 Pharmacy Compounding Advisory Committee (PCAC) meeting will recommend the durable shelf status — and a second meeting is already scheduled for early 2027. That means the legal picture in October 2026 may differ from the picture today.

Rather than scatter that story across a dozen pages, we keep one tracker. Below: what is actually on the docket, where Limitless stands and what we filed, where to understand sourcing and safety, the evidence on each specific peptide, and a dated log of every material development. If you are a current patient, nothing here changes your protocol without a direct conversation with Dr. Hare first.

On the docket

What the committee is actually reviewing.

Seven peptides across two days, under federal docket FDA-2025-N-6895 (regulations.gov). The day-one peptides are each nominated as two substances — free base and acetate salt — which the committee can vote on separately. Tesamorelin and tadalafil are not on the docket: both are already FDA-approved molecules and sit entirely outside this review.

Substance	Day	On Limitless menu?
BPC-157 free base / acetate	Day 1 (Jul 23)	Yes — indication-specific courses
TB-500 free base / acetate	Day 1 (Jul 23)	Yes — paired recovery protocol
MOTS-c free base / acetate	Day 1 (Jul 23)	Yes — standing stack adjunct
KPV free base / acetate	Day 1 (Jul 23)	Watching, not prescribing
DSIP	Day 2 (Jul 24)	Not on menu
Epitalon	Day 2 (Jul 24)	Not on menu
Semax	Day 2 (Jul 24)	Consult-only scenarios

CJC-1295 is not on this docket and is not currently legal for human compounding — why we removed it from the menu. Five additional peptides are slated for the early-2027 meeting; see the roadmap below.

The library, organized

Everything we've published on this, grouped.

Understand the meeting

What's on the table July 23–24The agenda, the salt-form nuance, and what each vote would mean.
The post-PCAC peptide roadmapTwelve docketed peptides across two meetings — which could join the menu.
Are peptides legal in 2026?The plain-language legal status, start to finish.

Where Limitless stands

We filed a comment with the FDAPatient-facing landing for our public filing.
The full filed comment textOur case to include BPC-157, TB-500, and MOTS-c — signed.
Hype vs. evidence — what we prescribeOur prescribing posture inside honest uncertainty.

Sourcing & safety

503A vs 503B vs "research use only"Where your peptides come from — and the one question that matters.
GLP-1 compounding statusThe parallel 503A/503B story for semaglutide and tirzepatide.
Our 503A partner-pharmacy statusWhich licensed pharmacies we source through.

The specific peptides

BPC-157 — the case at the FDAWhat the dossier in front of the committee contains.
MOTS-c — the mitochondrial peptideMechanism settled, human efficacy trials still missing.
KPV — strong signal, missing trialsWhy we're watching but not prescribing.

Update log

What's changed, dated.

2026-06-23

Re-verified the full agenda against the FDA's Federal Register notice and advisory-committee calendar (docket FDA-2025-N-6895): seven peptides across two days are confirmed — day one (July 23): BPC-157, KPV, TB-500, MOTS-c; day two (July 24): Emideltide (DSIP), Semax, Epitalon. The earlier vendor-blog chatter that floated a different slate is now superseded by the official posting. Comment window is open through July 22; comments filed by July 9 reach the committee before the vote. Posture unchanged — the meeting is now 30 days out.

2026-05-31

Folded the newest skeptic reporting — STAT ("BPC-157: big claims and scant evidence," Feb 3) and The Conversation ("the peptide problem") — into our hype-vs-evidence brief. Our posture is unchanged: prescribe inside named indications, source through 503A only, disclose the uncertainty. Launched this tracker to keep the whole story in one place ahead of the July meeting.

2026-05-30

Confirmed the public FDA agenda detail that each day-one peptide (BPC-157, KPV, TB-500, MOTS-c) is nominated as two substances — free base and acetate — which the committee can vote on separately. Updated the meeting explainer and our filed-comment page accordingly.

2026-05-15

Filed our formal public comment with the FDA ahead of the vote — a physician's case to include BPC-157, TB-500, and MOTS-c on the 503A bulks list, with per-lot certificate-of-analysis, stability, and written informed-consent conditions attached. Full text published.

2026-05-13

Removed CJC-1295 from the standing menu after verifying it is not currently legal for human compounding and is not on the July docket. Tesamorelin remains the GH-axis lead; sermorelin is the alternative; ipamorelin is conditional on partner-pharmacy formulary.

2026-04-23

FDA reclassification restored legal compounding of the affected peptides through licensed 503A pharmacies — the event that set the July 23–24 PCAC review in motion.