RegulationSILVER SPRING, Md. · Event April 15, 2026
FDA plans panel on LL-37, GHK-Cu, Melanotan II and more
No date, docket or briefing documents yet. All five are peptides FDA had placed in Category 2.
On the same day it moved a dozen peptides out of Category 2 (report), FDA posted an early announcement for a second Pharmacy Compounding Advisory Committee meeting on peptides. The page says FDA “will host an advisory committee meeting before the end of February 2027.” It was last updated April 15, 2026.
The five substances
The agenda lists five bulk drug substances “being considered for inclusion on the 503A bulks list”:
| Substance | What FDA’s Category 2 page said (summary) |
|---|---|
| Cathelicidin (LL-37) | Immunogenicity; nonclinical findings on male reproduction and possible protumorigenic effects |
| GHK-Cu (injectable routes) | Immunogenicity, aggregation; limited human data |
| Dihexa acetate | No human exposure data identified |
| Melanotan II | Case reports of melanoma, PRES, sympathomimetic toxidrome, priapism |
| Pegylated mechano growth factor (PEG-MGF) | No human exposure data identified |
The first column is from FDA’s meeting page. The second summarizes the safety language FDA kept on its Category 2 page after the nominations were withdrawn. Our Category 2 explainer quotes each entry in more detail.
What is not set
FDA’s page says the “time and location will be scheduled in the coming months.” It says FDA “intends to publish a Federal Register notice and establish a docket for public comment on this meeting in the near future.” As of October 19, 2026, we have not found that notice. No briefing documents are posted yet; FDA says it intends to post them no later than two business days before the meeting.
How this fits the 2026 sequence
The first 2026 meeting, on July 23 and 24, covered seven peptides. The committee voted in favor of six, against FDA staff’s recommendation (report). The second meeting will test whether that pattern holds for peptides with even thinner human data. FDA’s page notes that advisory committees “make non-binding recommendations.” Our PCAC process explainer explains what happens after a vote.
What changed: key dates
| Date | What happened |
|---|---|
| U.S. FDA: Meeting of the Pharmacy Compounding Advisory Committee (2027 meeting page) | |
| Event date for this report | |
| Amino Wire published this report |
Sources
2 linked records- [1] Meeting of the Pharmacy Compounding Advisory Committee (2027 meeting page) U.S. FDA · Primary record
- [2] Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. FDA (checked Oct 19, 2026) Primary record
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