GHK-Cu Compounding Pharmacy FDA and State Board Enforcement History

What is GHK-Cu's FDA status?

GHK-Cu is the copper(II) complex of GHK, a tripeptide found in human plasma, saliva and urine whose levels are reported to decline with age [4]. No FDA-approved drug is known to contain GHK-Cu [1]. Cosmetics do not need FDA approval before sale, so copper-peptide serums and creams are sold as cosmetics without it; a product marketed with disease-treatment or structure/function claims is regulated as a drug [5]. An injectable GHK-Cu product is not a cosmetic and is not FDA-approved [5].

Is GHK-Cu on FDA's compounding lists?

Non-injectable GHK-Cu. FDA's interim policy for state-licensed pharmacies and physicians lists 'GHK-Cu (except for injectable routes of administration)' in category 1 [1][3]. Category 1 substances may be eligible for the bulks list, and FDA generally does not intend to act against compounders using them if the conditions in its guidance are met [3]. Non-injectable GHK-Cu was removed from category 1 on April 22, 2026 when the nominations were withdrawn, then added back after a nominator clarified on May 5, 2026 that it had withdrawn only the injectable route; the list was updated May 14, 2026 [1][3].

Injectable GHK-Cu. FDA's 04/22/2026 safety-risk page lists 'GHK-Cu (for injectable routes of administration)' in its table of substances nominated but withdrawn [2]. FDA states that compounded injectable GHK-Cu 'may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities' and that there are 'limited data in humans to inform safety-related considerations' [2]. Injectable GHK-Cu is not in category 1 and is not in any category on FDA's current list [1].

Next step. FDA intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027 about whether to include GHK-Cu on the pharmacy bulks list; no vote has taken place [1].

Which FDA policies leave GHK-Cu out?

GHK-Cu is not on FDA's list of bulk substances for outsourcing facilities, updated March 21, 2025 [6]. It is not one of the six peptides named in HHS's October 2026 draft enforcement-discretion policy, which covers BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [7]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they reach patients [8].

Who does FDA's category 1 policy apply to?

FDA's interim policy addresses state-licensed pharmacies and physicians that compound [3]. The policy describes when FDA does not intend to take action; it does not describe state board of pharmacy actions [3].