GHK-Cu: FDA and compounding status

GHK-Cu is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).

As stated on the cited document, dated May 14, 2026.

FDA does not intend to take action against compounding with this substance while it evaluates the nomination. That is enforcement discretion under an interim policy — it is not inclusion on the Bulks List.

FDA lists "GHK-Cu (except for injectable routes of administration)" in 503A category 1. In FDA's words: it "was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators. On May 5, 2026, one of those nominators clarified that it intended to withdraw only its nomination of the injectable route of administration ... GHK-Cu (except for injectable routes of administration) will be added back to category 1." The non-injectable route is not named anywhere on FDA's bulk drug substances page — neither in its category 2 table nor in its withdrawn table, which lists only the injectable entry — so it was not part of the April 2026 category 2 removals. Orrick reports, as a secondary source, that GHK-Cu moved on the category 1 list rather than category 2. Read the withdrawn table's heading loosely: it calls its entries substances "previously in category 2 of the interim policies", yet FDA annotates ipamorelin acetate in that same table as still being in category 2 under the 503B interim policy. Category 1 is enforcement discretion under an interim policy, not inclusion on the 503A Bulks List, which holds six substances and no peptides.

As stated on the cited document, dated March 21, 2025.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

GHK-Cu for injectable routes of administration is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).

As stated on the cited document, dated April 22, 2026.

The nomination was withdrawn by the nominator, so FDA is no longer evaluating it. The substance came off the category it was in; it did not move onto the Bulks List.

FDA lists "GHK-Cu (for injectable routes of administration)" among the bulk drug substances nominated but withdrawn, in a table headed "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." FDA's section 503A nomination document says something different in shape: that "the nominations for GHK-Cu were withdrawn by the nominators", and that the route-qualified entry "GHK-Cu (except for injectable routes of administration)" came off category 1 on April 22, 2026. What FDA dates to May 5, 2026 is a nominator's clarification that it had meant to withdraw only the injectable route and wished to retain its non-injectable nomination; of the listing itself FDA writes only that the entry "will be added back to category 1", and the document as updated May 14, 2026 does carry it there. Neither document states which category the injectable route itself occupied before the withdrawal, and this tracker does not resolve it; Orrick reports, as a secondary source, that FDA removed GHK-Cu from category 1 as a whole. Treat the withdrawn table's heading as loose: FDA annotates ipamorelin acetate in the same table as still being in category 2 under the 503B interim policy. What is not in dispute is that the injectable nomination was withdrawn, was not among those retained, and is on no positive list today: it is in neither 503A category 1 nor the 503A Bulks List at 21 CFR 216.23(a).

As stated on the cited document, dated March 21, 2025.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.