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FDA 2027 COMPOUNDING REVIEW

Melanotan II

An established illicit consumer market preceding any acceptable therapeutic pathway.

Record version 1.0Last verified 5 September 2026Evidence grade DRegulatory surveillance cohort
FDA STATUS

Not FDA approved; committee consideration is not approval

MHRA / UK LICENCE

No UK marketing authorisation identified

NICE STATUS

No NICE recommendation identified

NHS ACCESS

No routine NHS access

PRIVATE LAWFUL USE CONTEXT

Not a licensed UK tanning treatment

EVIDENCE MATURITY

No authorised therapeutic tanning use and material safety concern

DEVELOPMENT PHASE

Regulatory surveillance cohort

MARKET EXPOSURE

Very high grey market

PROFESSIONAL RELEVANCE

Prioritise safety communication, exposure surveillance and differentiation from authorised melanocortin medicines.

Product, formulation and indication

No authorised product is represented for this investigational or surveillance record. Product level data will be added only when a sourceable regulated product exists.

Status history

Production baseline verification recorded.

Listed for forthcoming FDA PCAC consideration

Future material changes will be appended with their previous status and source; they will not be silently overwritten.

Verify this record

Source labels identify what each link can prove. Sponsor material is used for time sensitive development claims only.