U.S. regulatory status
CJC-1295
Also known as Modified GRF 1-29, DAC:GRF, CJC-1295 DAC
Is CJC-1295 legal right now?
CJC-1295 is not FDA-approved for any use and has no drug-shortage or USP-monograph pathway.
It previously appeared in Category 2 of the interim 503A bulks list but was removed around September 2024 after its nominations were withdrawn - which did not create a compounding pathway. At the December 4, 2024 advisory committee (PCAC) meeting, the committee voted against recommending it for the 503A list, citing insufficient efficacy and safety data.
It is neither on the 503A list nor otherwise eligible, leaving its legal compounding status effectively unchanged.
In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.
Verified Sep 22, 2026 (ET) · status held since Dec 4, 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 CJC-1295 to the 503A list.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Removed from Category 2 (~Sept 2024); PCAC voted against inclusion Dec 4, 2024; not on the 503A list; no USP monograph. |
| Australia (TGA) | Restricted | Reported as Schedule 4 (prescription-only) under the Poisons Standard. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation; supply for human use treated as an unlicensed medicine. |
| European Union (EMA) | Restricted | No EU marketing authorisation; absent from the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level. |
| Canada (Health Canada) | Restricted | Not authorized by Health Canada; named in an April 2026 public advisory on unauthorized injectable peptides, which states such products are illegal to sell and reports seizures. |
| Sport / anti-doping (WADA) | Restricted | Prohibited at all times under S2 as a growth-hormone-releasing factor analogue. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
Sources & transparency
Sources for this entry
- Federal Register - PCAC notice of meeting, Dec 4, 2024 Federal Register · primaryConfirms the Dec 4, 2024 PCAC meeting on nominated 503A bulk substances.
- FDA - PCAC December 4, 2024 meeting materials FDA · primaryDec 4, 2024 PCAC reviewed CJC-1295 and voted against recommending it for the 503A list.
- Health Canada public advisory (Apr 9, 2026) Health Canada · primaryBasis for the Canada (Health Canada) status row.
- Union Register of medicinal products (European Commission) EU · primaryBasis for the European Union (EMA) status row.
- BSCG - CJC-1295 in sport AnalysisProhibited at all times under WADA S2; not FDA-approved.
- Last verified by a human
- Sep 22, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
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This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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