U.S. Food and Drug Administration (FDA)
Is GHK-Cu (copper peptide) legal in United States?
Compounding restrictedNot approved as a drug; FDA treats non-injectable GHK-Cu as under evaluation (Category 1) but the injectable route is not covered
Pharmacy-made copies are tightly limited.
GHK-Cu (copper peptide) has no FDA-approved drug product. FDA's 503A category list, updated 14 May 2026, puts GHK-Cu 'except for injectable routes of administration' back in Category 1 (under evaluation, with enforcement discretion under FDA's interim policy) after one nominator kept its non-injectable nomination; the injectable nomination was withdrawn and FDA lists injectable GHK-Cu among withdrawn Category 2 nominations, so it has no protection. FDA plans to ask the Pharmacy Compounding Advisory Committee about GHK-Cu before the end of February 2027.
Last verified 2026-09-29 · how we verify
GHK-Cu (copper peptide) elsewhere
Sources (3)
- 01Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)U.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29
- 02Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 03Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29