U.S. regulatory status
Ipamorelin
Also known as Ipamorelin acetate
Is Ipamorelin legal right now?
Ipamorelin is not on the FDA's 503A Bulk Drug Substances List, so it is not approved for pharmacy compounding under enforcement discretion. Its interim-list nomination was withdrawn in 2024, removing it from Category 2 (the "significant safety risks" bucket) around September 2024; however, at the October 29, 2024 advisory committee (PCAC) meeting the committee voted against adding it to the list, citing insufficient human safety data and endocrine concerns. It is not part of the April 2026 peptide batch and does not appear on the July 2026 or February 2027 PCAC agendas, so it sits off both the restricted list and the permitted list, with no separate federal ban.
In limbo: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move.
Verified Jul 16, 2026 (ET) · status held since Oct 29, 2024
Where it sits in the process
- Nominated (stalled here - not advancing)
- Under review (not reached)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
FDA advisory committee voted against adding ipamorelin to the 503A list.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Removed from Category 2 (~Sept 2024); PCAC voted against 503A inclusion Oct 29, 2024; not on any bulks list; no separate ban. |
| Australia (TGA) | Restricted | Reported as Schedule 4 (prescription-only) under the Poisons Standard. |
| Sport / anti-doping (WADA) | Restricted | Prohibited at all times under S2 as a growth-hormone secretagogue. |
Sources & transparency
Sources for this entry
- FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryIpamorelin is not on the 503A (Category 1) list; the FDA 503A categories govern compounding eligibility.
- Federal Register - PCAC notice of meeting, Oct 29, 2024 Federal Register · primaryConfirms the Oct 29, 2024 PCAC meeting that reviewed ipamorelin (nomination withdrawn; committee voted against inclusion).
- A4PC - PCAC votes against four nominated bulk drug substances analysisCommittee voted against adding ipamorelin (among four substances) to the 503A list.
- FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisIpamorelin is not on the July 2026 or February 2027 PCAC agendas.
- Last verified by a human
- Jul 16, 2026 (ET) · how we verify
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- Peptlas Research Team - independent. About us.
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