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Is Melanotan II Legal? FDA, Compounding and WADA Status

Melanotan II's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureMelanocortin agonistUpdated
FDA status
Not approved
Off Category 2, 15 Apr 2026
PCAC vote
Not reviewed
not on the Jul 2026 PCAC agenda
WADA
Unclear
Not named on the 2026 list
Not legal adviceStatus reflects public FDA and WADA records on the date shown. Rules differ by country and state.

Current status

Off FDA Category 2 (Apr 2026)

No. Melanotan II is not FDA approved for any use. The FDA removed it from Category 2 on 15 Apr 2026.

Melanotan II: regulatory status by country
CountryStatusSource
United StatesNo approved product foundNo FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "Melanotan II" returned no matches on 2 Oct 2026.api.fda.govchecked 2 Oct 2026

Timeline

  1. FDA gives notice that 12 peptides will be removed from Category 2 (nominations withdrawn)FDA
Every peptide on the FDA tracker

Compounding and research-use sellers

  • Category 2 is the FDA's list of bulk substances it flagged as raising significant safety concerns. Compounding pharmacies are not expected to compound from them while they are on it.
  • The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on which substances belong on the 503A bulks list that pharmacies may compound from. Its votes are advice; the FDA decides.
  • "Research use only" products are sold outside these rules and are not checked by the FDA for identity, purity or dose.
  • Melanotan II was removed from Category 2 on 15 Apr 2026. Removal is not approval.

FDA compounding record: Melanotan II was removed from FDA's 503A category 2 after the nominators withdrew; FDA announced a PCAC consultation before the end of February 2027. · fda.gov, checked 2 Oct 2026

Sport and drug testing

WADA status unclear

Melanotan II: This is not named on the 2026 list. The catch-all class S0 prohibits any drug with no approval anywhere for human use, so it would be banned if no health authority has approved it, but we have not verified that for this substance.

Outside the US

Rules differ by country. What each regulator's own records show, with the date we checked:

Melanotan II: regulatory status by country
CountryStatusSource
United KingdomNo approved product foundNo approved product found in an emc (UK SmPC compendium) search for "Melanotan II" on 2 Oct 2026.medicines.org.ukchecked 2 Oct 2026
CanadaNo approved product foundNo product found in a Health Canada Drug Product Database search for ingredient "Melanotan II" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
AustraliaNo approved product foundNo approved product found in an ARTG search for "melanotan" on 2 Oct 2026.tga.gov.auchecked 2 Oct 2026
European UnionNo centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026ema.europa.euchecked 2 Oct 2026

Common questions

Is Melanotan II FDA approved?

No. Melanotan II is not FDA approved for any use. The FDA removed it from Category 2 on 15 Apr 2026.

Is Melanotan II legal to buy?

It is not an approved drug. Online sellers label it "for research use only, not for human use"; the FDA sent warning letters to five such sellers on 24 Aug 2026. Whether a pharmacy may compound it depends on its FDA bulk-substance status. Rules differ by country.

Is Melanotan II banned by WADA?

It is unclear. Melanotan II: This is not named on the 2026 list. The catch-all class S0 prohibits any drug with no approval anywhere for human use, so it would be banned if no health authority has approved it, but we have not verified that for this substance.

More on Melanotan II

DosageDoses used in published studies, with the source for each.CalculatorVial, water and dose to syringe units.Side effectsWhat labels and studies report, and what is unknown.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.How to injectSites, syringe types and hygiene, step by step.

Sources

  1. 1Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2; 'nominated but withdrawn' table, content current as of 22 Apr 2026)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  2. 2World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  3. 3United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "Melanotan II" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  4. 4US compounding: Melanotan II was removed from FDA's 503A category 2 after the nominators withdrew; FDA announced a PCAC consultation before the end of February 2027.U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  5. 5United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "Melanotan II" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
  6. 6Canada: No product found in a Health Canada Drug Product Database search for ingredient "Melanotan II" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  7. 7Australia: No approved product found in an ARTG search for "melanotan" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
  8. 8EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
  9. 9FDA gives notice that 12 peptides will be removed from Category 2 (nominations withdrawn)FDA · 2026fda.govAccessed 2 Oct 2026

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