U.S. regulatory status

GHK-Cu

Also known as Copper tripeptide-1, Copper peptide, GHK-copper

In limboInjectable removed from Category 2, not on the 503A list; PCAC review expected before end of Feb 2027

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enforcement discretion during evaluation), while injectable GHK-Cu was removed from Category 2 after its nomination was withdrawn - and removal from Category 2 does not by itself authorize compounding.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: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.

Verified Sep 22, 2026 (ET) · status held since Apr 22, 2026

Primary source: FDA All 8 sources

Where it sits in the process

  1. Nominated
  2. Under review
  3. Rulemaking
  4. Compounding-legal

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.

Next scheduled dateSecond PCAC meeting on peptides, incl. GHK-Cu - expected before end of Feb 2027, no date published - Feb 28, 2027 (in 140 days)

What changed last

  1. Injectable GHK-Cu removed from Category 2 without being placed on the 503A list - removal did not authorize compounding.

    Not legalizedView on frierlevitt.com

Status elsewhere

JurisdictionStatusNote
United States (FDA)In limboTopical route ≈ Category 1; injectable route removed from Category 2, not on the 503A list; PCAC review expected before end of Feb 2027.
Australia (TGA)UnscheduledNot individually named in the Poisons Standard; topical cosmetic products are freely available.
United Kingdom (MHRA)RestrictedNo UK marketing authorisation; supply as a medicine is unlicensed, though copper tripeptide-1 remains a permitted cosmetic ingredient under GB cosmetics law.
European Union (EMA)RestrictedNo EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level.
Canada (Health Canada)RestrictedNot in the Drug Product Database; Health Canada recalled GHK-Cu powder as an unauthorized active pharmaceutical ingredient in May 2026.
Sport / anti-doping (WADA)UnscheduledNot explicitly named on the Prohibited List.

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

Sources & transparency

Sources for this entry

Last verified by a human
Sep 22, 2026 (ET) · how we verify
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