Melanotan II
No Legal PathwaySexual Health / Tanning
Based on public FDA records, we don't see an approval or a shortage-list listing — both are usually preconditions for a 503A/503B exception. From what's publicly available, we don't find a compounding route under any formulation theory, but this is our reading of public sources, not legal advice.
Not legal advice. Every status on this page is our own reading of public FDA guidance, shortage listings, and committee materials — it has not been reviewed by an attorney and is not a legal determination. "Contested" means pharmacies and regulators publicly disagree, not that we're resolving the disagreement. Verify independently, and check with counsel, before relying on any entry here.
Current status
Never FDA-approved in any form. FDA issued a warning letter to Melanocorp Inc. (Hendersonville, TN) on Sept 7, 2007 for illegally selling and marketing Melanotan II as an injectable tanning product, including unsubstantiated skin-cancer and rosacea protection claims. No shortage-list history and no approved reference product exist, so no 503A/503B compounding pathway is available under any formulation theory.
Last changed: 2026-01-01
Enforcement history
- 2007-09-07
FDA warning letter to Melanocorp Inc. for illegal sale and marketing of unapproved Melanotan II as an injectable tanning product.
Source