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GHK-Cu regulatory status

Current status of GHK-Cu in the United States: Removed from Category 2 (Apr 2026). In sport: WADA status unclear. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of GHK-Cu?

Regulatory: Removed from Category 2 (Apr 2026)WADA: WADA status unclearVerified: Verified Sep 23, 2026
FDA and compounding
GHK-Cu has two regulatory tracks. As a cosmetic ingredient in topical products it is lawfully marketed without FDA premarket approval, provided no drug claims are made. As an injectable drug it is not FDA approved and is not a component of any approved drug. GHK-Cu for injectable routes was nominated for the 503A bulks list and placed in 503A Category 2; the FDA Category 2 page current as of April 22, 2026 now lists it under bulk drug substances nominated but withdrawn, so it is no longer in Category 2 but is not on the bulks list and was not reviewed by the Pharmacy Compounding Advisory Committee in July 2026. Because it is not on the bulks list, a 503A pharmacy has no federal basis to compound injectable GHK-Cu from bulk, and state boards cannot authorize what federal law does not. Injectable products sold as research chemicals are not lawful for human use.
WADA
WADA status unclear
Access path
  1. Topical cosmetic products containing GHK-Cu are sold over the counter without a prescription, as long as they make only cosmetic claims.
  2. No lawful compounded path for injectable GHK-Cu today: FDA lists it as a withdrawn 503A nomination, so it is off Category 2 but not on the 503A bulks list, and a 503A pharmacy has no federal basis to compound it from bulk.
  3. Not available as an FDA approved drug; injectable products labeled research use only are not lawful for human use.

Full GHK-Cu page: evidence, dosing in the literature, and sources

How has the status of GHK-Cu changed over time?

  1. FDA

    FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2

    FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.

    Regulatory: Removed from Category 2 (Apr 2026)Source: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for GHK-Cu and the source of each dated event.

  1. [1]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
  2. [2]FDA: Is it a cosmetic, a drug, or both? (or is it soap?)FDA, 2024
  3. [3]WADA Prohibited List, section S0 non-approved substancesWADA, 2026
  4. [4]FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)FDA, 2026

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