PeptideStatus ยท About

GHK-Cu: FDA & compounding status

FDA approvalNot approved
503A pharmacy (bulks list / category)Topical: returning to Category 1. Injectable: no pathway
FDA Category 2 safety-risk listInjectable GHK-Cu: listed under 'nominated but withdrawn' (FDA page current as of Apr 22, 2026). Topical status: Unknown (not yet verified against FDA category list) source
503A bulks list (21 CFR 216.23)Not listed. As of the eCFR text read Oct 20, 2026 the list holds six substances, none a peptide source
503B outsourcingNone
WADA 2026 Prohibited ListNot named in 2026 List. S0 catch-all covers substances with no government approval for human use anywhere; whether it applies is Unknown (check with your anti-doping body) source

FDA approval, 503A pathway and 503B cells: secondary source source, not yet checked against primary FDA records. Category 2, 216.23 and WADA cells: primary sources.

Timeline

DateEventSource
2027-02FDA to consult PCAC by end of Feb 2027source

Not medical or legal advice. PeptideStatus summarizes public regulatory sources for education only. It does not recommend using any substance. Rules change and vary by state. Talk to a licensed clinician and counsel. Status data verified only as of the source dates shown; Oct 19, 2026 build.