The short answer. Ipamorelin is not FDA-approved and has no compounding pathway. It is not under review either: FDA’s advisory committee voted 0 to 12, with one abstention, against listing both forms on October 29, 2024. As of September 25, 2026 it remains in 503B Category 2.
| FDA approved | No approved product in the US. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no 503A category. |
| 503B outsourcing facility | Ipamorelin acetate is in 503B Category 2 (significant safety risks) since Sep 29, 2023. |
| Latest FDA action | Warning letter to NuScience Peptides naming a tesamorelin and ipamorelin blend, Aug 24, 2026. |
| Sport | WADA prohibited (S2.2.4, growth hormone secretagogues). |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-25 |
The nomination was withdrawn, and FDA reviewed it anyway
Ipamorelin acetate went into 503A Category 2 on September 29, 2023. The nominators withdrew on September 19, 2024, and it left Category 2 by the September 27, 2024 update. FDA still took both forms to its advisory committee on October 29, 2024. The committee voted 0 yes, 12 no and 1 abstention on the free base, and the same on the acetate.
Pages that describe ipamorelin as “nomination withdrawn” or “under review” stop the story a month early. The review happened and went unanimously against listing.
503B is a separate list, and ipamorelin is on the restricted side of it
Outsourcing facilities work from their own bulks categories. On the 503B side, ipamorelin acetate has been in Category 2 since September 29, 2023, which FDA uses for substances that raise significant safety risks.
Blends carry the same problem
The CJC-1295 and ipamorelin stack is the most common way ipamorelin reaches clinics. Both halves lack a pathway: see the CJC-1295 page. FDA’s August 24, 2026 warning letter to NuScience Peptides named a tesamorelin and ipamorelin blend and rejected its research-use disclaimer.
What this means for you
Remove ipamorelin and any stack containing it. If you run a growth hormone axis program, the only candidate on this tracker with a defensible compounding position is sermorelin, and it has caveats of its own. Talk to us about how we build peptide programs around what can be sourced.
Read next
Frequently asked questions
Is ipamorelin legal to compound?
No. As of September 25, 2026 ipamorelin is not on the 503A bulks list and sits in no 503A category, and ipamorelin acetate is in 503B Category 2. FDA’s advisory committee voted 0 to 12 against listing both forms in October 2024.
Is ipamorelin still under FDA review?
No. The nominations were withdrawn in September 2024, and FDA’s advisory committee reviewed it anyway on October 29, 2024, voting 0 to 12 with one abstention against each form. No rule has followed, and ipamorelin acetate remains in 503B Category 2.
Is CJC-1295 with ipamorelin allowed?
No. Neither component has a compounding pathway. The advisory committee voted against listing CJC-1295 in December 2024 and against ipamorelin in October 2024, so a blend of the two has no route to lawful compounding. FDA named an ipamorelin blend in an August 2026 warning letter.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- 21 CFR 216.23, the 503A bulks list
- FDA briefing document, ipamorelin (Oct 2024 PCAC)
- FDA, PCAC minutes, Oct 29, 2024
- FDA, 503B bulk drug substance categories (updated Mar 21, 2025)
- FDA warning letter, Tailor Made Compounding (Apr 1, 2020)
- FDA warning letter, NuScience Peptides (Aug 24, 2026)
- WADA 2026 Prohibited List
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.