PCAC review · February 2027 panel
FDA's Pharmacy Compounding Advisory Committee scheduled to review the second cohort of peptides removed from Category 2 in April 2026. Panel votes whether to add each to the official 503A bulks list.
Melanotan II
Monograph · BCyclic seven-amino acid melanocortin agonist (broader receptor profile than PT-141). Stimulates melanin production and central libido pathways.
How it clearsHalf cleared in ~1h. Most (~96%) gone by ~5h.
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Mechanism, evidence, legal path, cost — all side-by-side.

Evidence is experimental. Most claims trace to limited human studies or animal models. Treat as a research direction, not a protocol.
Originally researched at University of Arizona for sun-protection. Tanning effect comes from MC1R activation (peripheral); libido from MC4R (central). Australia's TGA and the UK MHRA have warned consumers about safety. Multiple case reports of new melanomas under MT-II use.
Limited human data. The mechanism touches a sensitive regulatory axis, which means effects — when they appear — tend to be more pronounced than in other categories. Both undershoot and overshoot are real outcomes here. This is the tier where tracking matters most and flying blind costs most.
Multiple case reports linking MT-II to new melanomas and atypical mole changes. Regulators in AU/UK have issued explicit warnings. Strongly favor PT-141 (FDA-approved, narrower mechanism) over MT-II for any libido-only use.
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH₂. Same core as PT-141, amidated C-terminus.
Upload a lab file (LabCorp / Quest) or DNA file (23andMe / AncestryDNA). Stack will show your specific markers alongside the literature-reported response windows.
Upload in /historyPer-claim grading. Each claim is graded independently — same peptide, different claims can carry different grades.
External links to PubMed searches, ClinicalTrials.gov, and FDA materials. We do not host papers — we point at canonical sources.
FDA Cat. 2 removed Apr 2026 — PCAC review Feb 2027. AU/UK still warn consumers.
FDA's Pharmacy Compounding Advisory Committee scheduled to review the second cohort of peptides removed from Category 2 in April 2026. Panel votes whether to add each to the official 503A bulks list.
FDA published a Federal Register notice on April 15 2026 removing 12 peptides from the Category 2 ('significant safety concerns') compounding list, paving the way for PCAC review for inclusion on the 503A bulks list. Peptides removed: BPC-157, TB-500, Epitalon, GHK-Cu (injectable), MOTS-c, DSIP, Dihexa Acetate, MK-677, Melanotan II, KPV, Semax, LL-37.
FDA's Pharmacy Compounding Advisory Committee categorized a wide list of peptides as Category 2 ('significant safety concerns'), effectively banning their compounding at 503A and 503B pharmacies. Affected: BPC-157, TB-500, Epitalon, GHK-Cu, MOTS-c, DSIP, Dihexa, MK-677, Melanotan II, KPV, Semax, Selank, LL-37 and others.
Pre-filled with this compound's published dose range: 0.25-1 mg · varies, subcutaneous
Calculator is a discussion tool. Verify reconstitution + dosing with a qualified provider. Stack is not a prescription source. Use sterile technique and inspect every vial.
How much a first cycle actually costs across the channels people use. Pick the protocol length you're considering — Stack multiplies the monthly band by cycle weeks. Same caveats apply: ranges are facts, quality varies, this is not legal advice.
Numbers reflect publicly-advertised price ranges, not vendor quotes. Insurance, prescription costs, and shipping aren't included. Channels marked unavailable are filtered out.
See pharmacies for this compound →Approximate monthly cost across the channels users actually consider — brand FDA-approved retail, US 503A compounding, Mexican pharmacies, MX farmacias magistrales, and the research-grey market. Stack lists ranges, not vendor names. Quality varies wildly across channels — see each band's note.
Dosing assumption: 250 µg/day loading then 250-1000 µg as needed (skin tanning + libido)
Research-grey only. Counterfeit and underdosed product common — TGA (Australia) has issued multiple consumer warnings. Side-effect profile (nausea, flushing, mole darkening) is the real cost, not the dollar cost. On the Feb 2027 PCAC docket.
As of 2026-04Public-source attribution across the production + distribution chain. Stack does not endorse vendors — this is who is in the chain, not which one is best.
Long-established US vendor (7+ years). Broad catalog including GHRPs, GHRHs, and cognitive peptides. Third-party HPLC and mass-spec COA per batch. Active Finnrick Analytics coverage.
For laboratory use only / not for human consumption. Stack may earn affiliate commissions.
Established vendor with multi-year community track record. Offers peptide blends (Wolverine Stack, etc.) alongside singles. Third-party COA available on request.
For laboratory use only / not for human consumption. Stack may earn affiliate commissions.
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Next visit & citations
Running this compound? Log it in /history, then open Dr Passport before your visit. Methodology explains grades; the research dashboard sorts the full catalog with citations.