GHK-Cu Injection
FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.FDA’s documents list it as GHK-Cu.
GHK-Cu for non-injectable use, such as topical, is in FDA's 503A Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503A pharmacy that compounds it against a patient-specific prescription while the interim policy's conditions are met. That is enforcement discretion, not a listing, and it has already been withdrawn once. Injectable GHK-Cu has no compounding pathway. Compounded GHK-Cu is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
FDA's Category 1 entry reads "GHK-Cu (except for injectable routes of administration)". It covers non-injectable routes, such as topical use, only. Subcutaneous, intramuscular and intravenous GHK-Cu are outside it.
- Basis
- FDA's 503A categories document (updated May 14, 2026) lists "GHK-Cu (except for injectable routes of administration)" in Category 1, bulk drug substances under evaluation. FDA removed GHK-Cu from Category 1 on April 22, 2026 after its nominations were withdrawn. On May 5, 2026 one nominator clarified that it meant to withdraw only the injectable route, and FDA added the non-injectable entry back. GHK-Cu is not in any 503B category and is not on the 503A bulks list in 21 CFR 216.23. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.
- Checked on
- October 13, 2026
- Full record
- FDA status record for GHK-Cu Injection
