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Is Melanotan II legal? FDA status and US regulatory standing
Current status
Compounding nomination withdrawn. Melanotan II was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists.
Primary source: www.fda.gov
Federal legal status
FDA approval status
Melanotan II was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Not FDA-approved. Not to be confused with bremelanotide (PT-141/Vyleesi, which is approved). No NDA. Sold illicitly as research chemical. FDA warns against injectable tanning products.
Also known as
MT-II · MT2 · Melanotan 2
Frequently asked questions
- Is Melanotan II FDA approved?
- Melanotan II was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Primary source linked on this page.
- Is Melanotan II legal to buy?
- Melanotan II is available in the U.S. as a research-use-only compound. It was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Sale for human consumption is not permitted.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .