vialauditThe Roundup
MELANOTAN II·US LEGAL STATUS·LAST CHECKED 12 OCT 2026

Is Melanotan II legal?

Not as a drug. Melanotan II has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. Pharmacies cannot compound it.

RESEARCH-LABELLED SALE
Unapproved drug
PHARMACY COMPOUNDING
No
PRESCRIPTION
No approved product
WADA 2026
Prohibited (S0)

DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION

Federal, compounding and sport status

CHECKED 12 OCT 2026

Federal status

FDA approval
no approval
DEA scheduling
not scheduled
503A compounding
FDA interim category: Nominated but withdrawn (off Category 2, not eligible)
503A Bulks List: not on list
Not eligible. Removed from Category 2 on 15 Apr 2026 after the nominations were withdrawn. FDA says the PCAC will review it before the end of February 2027; no date set as of 12 Oct 2026.
FDA Warning Letters
  • Aug 30, 2007 — Melanocorp Inc. (cited: melanotan-2) · LETTER ↗
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: Foundational FDA enforcement target (Melanocorp 2007). Selling MT-2 with cosmetic/therapeutic claims is direct FDCA §301 violation. Even with RUO disclaimers, FDA has prosecuted sellers when 'research' framing is pretextual.
Personal possession: Not federally criminalized. UK MHRA has stricter enforcement.

Sport-body status

WADA 2026
prohibited · class S0 · in and out of competition
Not named. S0 covers any pharmacological substance with no current approval by any government for human therapeutic use, and we found no such approval. WADA's 2027 List, in force from 1 Jan 2027, now names 'peptides' among the S0 examples; the status does not change.
USADA
NCAA
unknown

What we couldn’t verify

State rules

NONE FOUND

We found no state statute, board rule or enforcement action that names Melanotan II. The federal position above applies in all 50 states and DC.

What changed at the last check

2 CHANGES
DateFieldWasNowWhy
12 Oct 2026WADA 20272027 List not yet publishedprohibited (S0), unchangedWADA published the 2027 List on 21 Sep 2026. It adds 'peptides' to the S0 examples of substances with no approval for human therapeutic use. Status unchanged. source ↗
12 Oct 2026WADA 2026not prohibitedprohibited (S0)Not named. S0 covers any pharmacological substance with no current approval by any government for human therapeutic use, and we found no such approval. source ↗

Questions

3 ANSWERS
Is Melanotan II legal in the US?

Not as a drug. Melanotan II has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. Pharmacies cannot compound it.

Can a pharmacy compound Melanotan II?

Not eligible. Removed from Category 2 on 15 Apr 2026 after the nominations were withdrawn. FDA says the PCAC will review it before the end of February 2027; no date set as of 12 Oct 2026.

Is Melanotan II banned in sport?

Yes. It is prohibited at all times under WADA 2026 class S0. Not named. S0 covers any pharmacological substance with no current approval by any government for human therapeutic use, and we found no such approval. WADA's 2027 List, in force from 1 Jan 2027, now names 'peptides' among the S0 examples; the status does not change.

Sources

6 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. FDA warning letter to Melanocorp Inc., 30 Aug 2007
  5. WADA 2026 Prohibited List
  6. Source for: WADA 2027
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