The planned early-2027 PCAC review

FDA intends to convene the Pharmacy Compounding Advisory Committee before the end of February 2027 to review five more peptides for the 503A Bulks List. FDA has not posted an exact date — so this page states the window, not a day, and will carry the date when the notice publishes.

A PCAC vote does not change what is legal. The committee advises; FDA is not bound by it. A vote alone establishes neither permission nor prohibition. Category 1 nominations and conditional interim policy are distinct from final-list rulemaking.

Recorded status is not an eligibility determination. PCAC recommendations are advisory. Category 1 is a nomination under FDA evaluation, distinct from the final 503A Bulks List established by rulemaking. FDA’s January 2025 interim policy describes conditional enforcement discretion, not FDA approval or unconditional permission. Its Category 1 conditions include manufacturer registration, a valid certificate of analysis and all other applicable 503A conditions; that policy does not apply to Category 2. Assess the exact substance, form and route against the applicable monograph, approved-drug-component, final-list and interim-policy provisions.

FDA January 2025 interim guidance ↗

FDA’s May 14, 2026 nomination document lists GHK-Cu except for injectable routes in Category 1, following a May 5 clarification of the withdrawal. Injectable GHK-Cu is discussed separately among withdrawn nominations with safety concerns. The non-injectable listing does not establish injectable eligibility or unconditional compounding permission.

FDA May 14, 2026 nomination document ↗

Tracker collector’s last successful poll: not available on this public page. The aggregate polling signal on the tracker index covers multiple sources.

Per-substance authority reconciliation: no documented date is provided here. A recent source event or poll does not establish complete coverage of FDA updates.

Source-event dates and recent source polls do not establish that each substance’s current eligibility has been reverified.

Standings below may be behind. Our most recent published status event is from Jul 23, 2026 (114 days ago). Verify against the FDA record before acting.

The five peptides under review

FDA’s announced agenda names LL-37, GHK-Cu, Dihexa acetate, Melanotan II and PEG-MGF. Published tracker records below do not resolve current substance/form/route eligibility.

Dihexa acetatePCAC review planned before end of Feb 2027 — exact date unannounced
GHK-CuPCAC review planned before end of Feb 2027 — exact date unannounced
LL-37PCAC review planned before end of Feb 2027 — exact date unannounced
Melanotan IIPCAC review planned before end of Feb 2027 — exact date unannounced
PEG-MGFPCAC review planned before end of Feb 2027 — exact date unannounced

What each outcome would mean

PCAC recommends listing

The committee recommends adding the substance to the final 503A Bulks List. FDA is not bound by it; a vote is neither final-list inclusion nor FDA approval. Assess existing bulk-substance provisions and conditional interim policy separately. No fixed rulemaking duration is established here.

PCAC recommends against listing

The committee advises against list inclusion. That recommendation alone establishes neither a final FDA decision nor a universal compounding prohibition. July 2026 tallies in the tracker remain reported records; primary tally verification is not established here.

Deferred or no vote taken

A deferral or request for more information is not a final-list rule. Current individual eligibility still requires the applicable substance, form, route and policy conditions; it cannot be inferred from a missing vote.

Where this comes from

The intended review window is sourced to FDA’s Pharmacy Compounding Advisory Committee announcement. That announcement says time and location will be scheduled later; this page does not certify a subsequently published date.

FDA · Pharmacy Compounding Advisory Committee ↗

For bulk-substance provisions, interim policy and final-list rulemaking, see the 503A pathway. For dated published substance records, see the substance tracker.

Informational monitoring compiled from public government sources — not legal or medical advice. No efficacy claims. Verify against the primary source and your own counsel before acting.

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