U.S. regulatory status
GHK-Cu
Also known as Copper tripeptide-1 · Copper peptide · GHK-copper
Is GHK-Cu legal right now?
GHK-Cu (copper tripeptide-1) is not FDA-approved and its 503A compounding status splits by route of administration. Topical, non-injectable GHK-Cu is treated as a Category 1 substance (compoundable under enforcement discretion during evaluation), while injectable GHK-Cu was removed from Category 2 after its nomination was withdrawn - and removal from Category 2 does not by itself authorize compounding. Injectable GHK-Cu therefore sits in limbo, neither prohibited nor affirmatively permitted, awaiting FDA advisory committee (PCAC) review. It was not on the July 23-24, 2026 PCAC agenda; it is one of five substances - alongside LL-37, Dihexa acetate, Melanotan II and PEG-MGF - expected at a second PCAC meeting the FDA has signalled for before the end of February 2027, though no date has been published. That meeting would also be advisory: the six peptides the committee recommended in July 2026 are still not on the 503A list.
In limbo: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move.
Verified Aug 11, 2026 (ET) · status held since Apr 22, 2026
Where it sits in the process
- Nominated (passed)
- Under review (stalled here - not advancing)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
Injectable GHK-Cu removed from Category 2 without being placed on the 503A list - removal did not authorize compounding.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Topical route ≈ Category 1; injectable route removed from Category 2, not on the 503A list; PCAC review expected before end of Feb 2027. |
| Australia (TGA) | Unscheduled | Not individually named in the Poisons Standard; topical cosmetic products are freely available. |
| Sport / anti-doping (WADA) | Unscheduled | Not explicitly named on the Prohibited List. |
Sources & transparency
Sources for this entry
- FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryInjectable GHK-Cu is not on the 503A list; the FDA 503A categories define what pharmacies may compound.
- Frier Levitt - FDA to remove peptides from the Category 2 list (2026) analysisNon-injectable GHK-Cu removed from Category 1 then reinstated; injectable slated for PCAC before Feb 2027.
- National Law Review - What FDA's latest actions mean for peptide compounding analysisRemoval from Category 2 does not, on its own, authorize compounding.
- FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisGHK-Cu among peptides slated for a second PCAC review before end of February 2027.
- Orrick - FDA peptide compounding vote: what to watch at the July PCAC meeting analysisNames the five substances expected at the second PCAC meeting: LL-37, GHK-Cu, Dihexa acetate, Melanotan II, PEG-MGF.
- Last verified by a human
- Aug 11, 2026 (ET) · how we verify
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