Legal status · Record reviewed
Afamelanotide has no single legal status. It depends on the product and how it is supplied.
FDA has approved Scenesse for set uses. The approval covers only that product, not every product sold under the name Afamelanotide.
Sports: we have no current sports-rule review for it yet.
Rules for buying, selling, and prescribing also depend on how a product is made and sold, and on state law.
Whether you may buy, sell, or use a product also depends on pharmacy (compounding) rules, a prescription, and state law. Read how U.S. peptide law works.
Have a product in hand? Check if it is a prescription, compounded, or research-only product.
FDA-approved product
FDA approved one or more named products for set uses. The approval covers those products only, not every product sold under the same name.
What the record says: An FDA-approved implant exists for a rare-disease indication
Not named on this FDA page
This FDA page does not name it. That does not show that a pharmacy may compound it. Other FDA lists and conditions still apply.
Source: FDA's page of bulk drug substances that may present significant safety risks. FDA marks it current as of . We checked it on .
Not assessed
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
Check the current World Anti-Doping Agency list and your sport's rules before you compete.
Other names in this record: Scenesse, Nle4-D-Phe7-alpha-MSH, melanocortin-1 agonist.
What it is, what studies in people show, and what is still unknown.
Open the Afamelanotide recordSee the FDA, compounding, and sports status of every peptide we reviewed in one table.
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