A naturally occurring copper-binding tripeptide used in skin care. Only non-injectable forms have a 503A pathway.
Key takeaway
GHK-Cu is a three-amino-acid peptide (glycine-histidine-lysine) bound to copper. It occurs naturally in plasma and is widely used in topical skin-care products.
At a glance
| FDA status | Not FDA-approved |
|---|---|
| 503A compounding | 503A Category 1: under FDA evaluation, compounding allowed under interim policy |
| Body areas | Skin & hair |
| Through ScriptMates | Prescribable by licensed providers |
| Open questions | 1 noted below |
What is GHK-Cu?
GHK-Cu is a three-amino-acid peptide (glycine-histidine-lysine) bound to copper. It occurs naturally in plasma and is widely used in topical skin-care products.
FDA treats it differently by route. Non-injectable GHK-Cu is in 503A Category 1 (under evaluation). The injectable nomination was withdrawn after FDA raised immunogenicity concerns.
Dosage forms
No FDA-approved dosage form. FDA distinguishes non-injectable routes from injection in its compounding records; those records do not specify an approved finished dosage form.
Is GHK-Cu FDA-approved?
Not FDA-approved. “GHK-Cu (except for injectable routes)” is in 503A Category 1. FDA plans to consult its compounding advisory committee before the end of February 2027.
Can it be prescribed through ScriptMates?
503A Category 1: under FDA evaluation, compounding allowed under interim policy. A 503A partner pharmacy lists this peptide, and it has a lawful 503A compounding pathway.
What we could not confirm
- Prescribing applies to topical or other non-injectable forms only. Injectable GHK-Cu has no 503A pathway.
Sources
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
- FDA: Bulk substances that may present significant safety risks (Category 2 and withdrawn nominations)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.