GHK-Cu: FDA & Compounding Status in the United States

FDA approval

GHK-Cu is not an FDA-approved drug. There is no new-drug approval that authorizes a human therapeutic use. Cosmetic interest and the existence of trials do not change that sentence.¹

A topical trial of 13 participants is not approval. A recruiting Phase 2 registry record is not approval. A systematic review in aesthetic medicine is not approval.^5,4,3

This page does not interpret Mexican law and does not turn a U.S. document into a local authorization. The scientific hub of the cluster is GHK-Cu: research and evidence.

503A nomination history

In the United States, section 503A of the Federal Food, Drug, and Cosmetic Act governs part of pharmacy compounding. Bulk substances nominated for the 503A list are placed, while they are evaluated, in interim categories. Being in a category is not being approved as a drug.

Category 1, in the interim policy, means the substance is under evaluation for possible inclusion. It does not mean FDA has accepted it. Category 2 flags significant safety concerns identified while nominations were reviewed. Leaving a category because a nomination was withdrawn also does not close the matter as a final regulation.

FDA’s 22 April 2026 update states that “GHK-Cu (except for injectable routes of administration)” was removed from Category 1 because nominations were withdrawn. It also states that “GHK-Cu (for injectable routes of administration)” was removed from Category 2 because nominations were withdrawn.¹

A withdrawn nomination is not final inclusion on the 503A list. It is also not final exclusion by regulation. It is an administrative fact about nominations, not an efficacy verdict.

The routes should stay separate. The non-injectable nomination and the injectable nomination are not the same object. Topical skin evidence — Miller 2006, the NCT07437586 gel — is not used here to discuss compounding for injectable routes.^5,4

Planned PCAC consultation

FDA has stated that it intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027 regarding potential inclusion of GHK-Cu on the 503A bulks list.¹

That is a future intention, not a completed event. Before the end of February 2027 does not mean the consultation has already happened, that the committee has already voted, or that the Agency has already listed or rejected the substance.

An advisory committee offers advice. The advice, when it exists, will not by itself be a drug approval. This page does not anticipate the outcome.

The calendar should not be read as a verdict in advance. “Before the end of February 2027” is a window the Agency set for itself. If the consultation is delayed, brought forward, or changed in scope, the new administrative fact will need to be cited with its date. Until then, the status is: declared intention, event not yet occurred.

Safety concerns described for the injectable route

That paragraph is left in its scope. It discusses compounded injectable drugs. It is not generalized to a topical serum, to the Miller trial, or to the NCT07437586 gel.

This cluster does not offer an administration technique, a reconstitution step, or a quantity. Summarizing the Agency’s concern is not a use instruction.

That note is also not used to discuss a topical gel or a serum. FDA scoped the wording to compounded injectable drugs. Mixing that sentence with Miller 2006 or NCT07437586 would change route without evidence.

The limited human data the Agency mentions, in that paragraph, are safety data to inform injectable compounding. They are not a verdict on topical skin evidence, and they do not make GHK-Cu an approved drug or a rejected drug.

United States versus Mexico

• The text above is United States compounding law and policy.¹
• It is not a COFEPRIS interpretation and not an import guide.
• It does not authorize a human use in any country.
• A certificate of analysis for a research lot does not change 503A status.

If the question is what has been studied in people, not what a U.S. pharmacy may compound, the useful page is human clinical studies. If the question is what the molecule is, that is in What Is GHK-Cu.