RegulationSILVER SPRING, Md. · Event October 29, 2024
FDA advisers reject ipamorelin, kisspeptin-10, ibutamoren
No substance on the agenda drew more than one vote in favor. The minutes were approved in January 2025.
FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted on October 29, 2024 against recommending four nominated bulk drug substances for the 503A bulks list: ipamorelin (two salt forms), kisspeptin-10, ibutamoren mesylate and L-theanine. The committee’s final summary minutes, approved on January 15, 2025, record the counts.
The votes
FDA framed each question the same way. It proposed that the substance not be included on the 503A bulks list, then asked members whether it should be placed on the list.
| Substance | Yes | No | Abstain |
|---|---|---|---|
| L-theanine | 1 | 12 | 0 |
| Ibutamoren mesylate | 1 | 13 | 0 |
| Ipamorelin (free base) | 0 | 12 | 1 |
| Ipamorelin acetate | 0 | 12 | 1 |
| Kisspeptin-10 | 0 | 11 | 0 |
A separate question asked whether hydroxyprogesterone caproate should go on the list of drugs withdrawn or removed from the market for safety or effectiveness reasons. Members voted 9 to 0 in favor.
Who asked for these substances
The 503A bulks list is built from public nominations. The minutes list speakers for the nominators, James Lavalle and Lee Rosebush, presenting on behalf of Farmakeio and Evexias. FDA’s review team presented its own evaluation of each substance against the four statutory factors: physical and chemical characterization, safety, effectiveness, and historical use in compounding.
The meeting was announced in a Federal Register notice published September 18, 2024 (docket FDA-2024-N-4188).
What the vote did and did not do
A PCAC vote is a recommendation. It does not change what pharmacies may compound on the day of the vote. FDA decides whether to propose a substance for the list, and any listing happens by rulemaking.
Several of the same substances also appear on FDA’s separate Category 2 page, the interim list of nominated substances where FDA has identified significant safety risks. Our Category 2 explainer tracks which of them are still there. As of October 19, 2026, FDA’s page still lists ipamorelin acetate, kisspeptin-10 and ibutamoren in active Category 2 for 503A, 503B or both.
Why it matters now
The October 2024 meeting is the baseline for the 2026 debate. In July 2026 the committee voted in favor of six of seven peptides on its agenda (our report). Comparing the two meetings is the clearest way to see how much the committee’s posture changed in under two years.
What changed: key dates
| Date | What happened |
|---|---|
| Office of the Federal Register (govinfo): Federal Register notice 2024-21241: Pharmacy Compounding Advisory Committee; notice of meeting | |
| Event date for this report | |
| U.S. FDA: Final summary minutes, PCAC meeting of October 29, 2024 | |
| Amino Wire published this report |
Sources
3 linked records- [1] Final summary minutes, PCAC meeting of October 29, 2024 U.S. FDA · Primary record
- [2] Federal Register notice 2024-21241: Pharmacy Compounding Advisory Committee; notice of meeting Office of the Federal Register (govinfo) · Primary record
- [3] October 29, 2024 meeting of the Pharmacy Compounding Advisory Committee (meeting page) U.S. FDA Primary record
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