U.S. regulatory status

CJC-1295

Also known as Modified GRF 1-29 · DAC:GRF · CJC-1295 DAC

In limboPCAC voted against listing (Dec 2024); off Category 2, not on the 503A list

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appeared in Category 2 of the interim 503A bulks list but was removed around September 2024 after its nominations were withdrawn - which did not create a compounding pathway.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: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move.

Verified Jul 7, 2026 (ET) · status held since Dec 4, 2024

Primary source: Federal Register All 3 sources

Where it sits in the process

  1. Nominated
  2. Under review
  3. Rulemaking
  4. Compounding-legal

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

  1. FDA advisory committee voted against adding CJC-1295 to the 503A list.

    Not legalizedView on federalregister.gov

Status elsewhere

JurisdictionStatusNote
United States (FDA)In limboRemoved from Category 2 (~Sept 2024); PCAC voted against inclusion Dec 4, 2024; not on the 503A list; no USP monograph.
United Kingdom (MHRA)RestrictedNo UK marketing authorisation; supply for human use treated as an unlicensed medicine.
Australia (TGA)RestrictedReported as Schedule 4 (prescription-only) under the Poisons Standard.
Sport / anti-doping (WADA)RestrictedProhibited at all times under S2 as a growth-hormone-releasing factor analogue.

Sources & transparency

Sources for this entry

Last verified by a human
Jul 7, 2026 (ET) · how we verify
Who runs this
Peptlas Research Team - independent. About us.
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Confidence
medium - some facts here rest on secondary reporting. Always confirm against the primary source before you rely on it.

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