FDA table of bulk drug substances nominated for compounding — injectable GHK-Cu, nomination withdrawn
U.S. Food and Drug AdministrationFDA compounding communications
- Objective
- To record that FDA's published compounding entry is scoped to injectable routes.
- Endpoint investigated
- Compounding classification for injectable routes
Listed on the withdrawn-nominations table, scoped specifically to injectable routes of administration. Published concerns include immunogenicity risk from aggregation and impurities, and limited human data. Cosmetic INCI use of Copper Tripeptide-1 is a different regulatory bucket.
Limitations. The FDA entry is route-scoped. It is not a review of topical cosmetic literature.
FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026
