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enforcement discretion during evaluation), while injectable GHK-Cu was removed from Category 2 after its nomination was withdrawn - and removal from Category 2 does not by itself authorize compounding.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 scheduled before the end of February 2027. It was not on the July 2026 PCAC agenda.
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 Jul 7, 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 before 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 scheduled for a second PCAC review before end of February 2027.
- Last verified by a human
- Jul 7, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
- Confidence
- medium - some facts here rest on secondary reporting. Always confirm against the primary source before you rely on it.
This page reports publicly available regulatory status for information only. It isnot medical or legal advice and makes no health claim. See ourfull disclaimer.
Get alerted when GHK-Cu's status changes
We'll email you only when this entry's official status moves - and never anything else.