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

Is Melanotan I legal?

Yes, as a prescription drug: FDA has approved it (Scenesse). A vial sold as a 'research peptide' is not the approved product, and selling it for human use breaks federal drug law. Pharmacies may compound it only when the product is not a copy of the approved drug.

RESEARCH-LABELLED SALE
Unapproved copy of an Rx drug
PHARMACY COMPOUNDING
Only if not a copy
PRESCRIPTION
FDA-approved (Scenesse)
WADA 2026
Not listed

DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION

Federal, compounding and sport status

CHECKED 12 OCT 2026

Federal status

FDA approval
approved as drug · brand: Scenesse · NDA 210797 · approved Oct 8, 2019
Indications: Increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP)
DEA scheduling
not scheduled
503A compounding
FDA interim category: Component of an FDA-approved drug
503A Bulks List: not on list
Afamelanotide is the active ingredient of Scenesse, an implant given by a health professional. 503A rules on approved components and 'essentially a copy' apply; we found no FDA statement on compounded afamelanotide.
FDA Warning Letters
none on record for this compound
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: Critical cross-reference: Afamelanotide = Melanotan I = Scenesse. Vendors selling lyophilized 'Melanotan I' powder for SC injection are selling the same molecule as Scenesse, just a different dose form. This is FDCA §505 unapproved drug + §301 misbranding + potential §304 anti-counterfeiting.
Personal possession: Not federally criminalized.

Sport-body status

WADA 2026
not prohibited
Afamelanotide is an approved drug (Scenesse), so S0 does not apply, and melanocortin agonists are not otherwise listed.
USADA
not banned
NCAA
unknown

What we couldn’t verify

State rules

NONE FOUND

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

Questions

3 ANSWERS
Is Melanotan I legal in the US?

Yes, as a prescription drug: FDA has approved it (Scenesse). A vial sold as a 'research peptide' is not the approved product, and selling it for human use breaks federal drug law. Pharmacies may compound it only when the product is not a copy of the approved drug.

Can a pharmacy compound Melanotan I?

Afamelanotide is the active ingredient of Scenesse, an implant given by a health professional. 503A rules on approved components and 'essentially a copy' apply; we found no FDA statement on compounded afamelanotide.

Is Melanotan I banned in sport?

It is not on the WADA 2026 Prohibited List. Afamelanotide is an approved drug (Scenesse), so S0 does not apply, and melanocortin agonists are not otherwise listed.

Sources

4 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. WADA 2026 Prohibited List
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