FDA compounding status
GHK-Cu
Also listed as Copper tripeptide-1, Copper peptide 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 That is enforcement discretion, not a listing, and it has already been withdrawn once.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.
Checked against the primary sources on .
The record
- FDA status
- FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.
- Compounding basis
- 503A pharmacy (Category 1, interim policy)Compounded by a state-licensed 503A pharmacy against a patient-specific prescription. The substance is in FDA's 503A Category 1: FDA has said it does not intend to take action while the substance is under evaluation, if the interim policy's conditions are met. This is enforcement discretion, not the bulks list.
- Injectable routes (subcutaneous, intramuscular and intravenous)
- No compounding pathway today.
- No compounding pathway
- FDA advisory committee
- Review announced, expected by Feb 28, 2027
- Sport (WADA 2026)
- Not named on the WADA 2026 Prohibited List.
- Offered by PEPLUX
- Yes, as GHK-Cu Injection
- Checked on
Offered by PEPLUX
GHK-Cu Injection
PEPLUX offers GHK-Cu as GHK-Cu Injection. The product page covers what it is, its risks, and how prescribing and pricing work.
Basis
What this status traces to.
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 FDA removed GHK-Cu from Category 1 on April 22, 2026 after its nominations were withdrawn.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.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated April 15, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDABulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA advisory committeeMeeting of the Pharmacy Compounding Advisory Committee (early announcement)Document dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA has announced that it intends to consult its Pharmacy Compounding Advisory Committee on it, by February 28, 2027. A consultation or a recommendation is not a listing.
Meeting of the Pharmacy Compounding Advisory Committee (early announcement) (dated )
If you are subject to anti-doping rules
Not named on the WADA 2026 Prohibited List.
Pending or unconfirmed
FDA has announced it intends to consult its Pharmacy Compounding Advisory Committee before the end of February 2027 on whether GHK-Cu should be added to the 503A bulks list. A committee recommendation would not be a listing. Whether WADA's class S0 (non-approved substances) reaches GHK-Cu has not been confirmed.
Common questions
GHK-Cu, answered plainly.
- What is the FDA compounding status of 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.
- What does the status of GHK-Cu trace to?
- 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 against the primary sources on October 13, 2026.
- Does the same status apply to every route of GHK-Cu?
- No. Injectable routes (subcutaneous, intramuscular and intravenous): Injectable GHK-Cu has no compounding pathway today. FDA's Category 1 entry excludes every injectable route of administration, and injectable GHK-Cu is not on the 503A bulks list or in any 503B category. Injectable GHK-Cu is not FDA-approved.
- Does PEPLUX offer GHK-Cu?
- PEPLUX offers GHK-Cu as GHK-Cu Injection. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. GHK-Cu is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Is GHK-Cu prohibited in sport?
- Not named on the WADA 2026 Prohibited List.
- Is anything about the status of GHK-Cu pending or unconfirmed?
- FDA has announced it intends to consult its Pharmacy Compounding Advisory Committee before the end of February 2027 on whether GHK-Cu should be added to the 503A bulks list. A committee recommendation would not be a listing. Whether WADA's class S0 (non-approved substances) reaches GHK-Cu has not been confirmed.