U.S. Food and Drug Administration (FDA)
Is CJC-1295 legal in United States?
Not approvedNo FDA approval; FDA lists CJC-1295 among withdrawn nominations and cites serious adverse events, so it is not on the 503A list
Not approved as a medicine here.
CJC-1295 is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and states that FDA identified serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction, with limited clinical data. It was not on the July 2026 advisory committee agenda and is not on the 503A bulks list, so there is no FDA policy protecting compounding of it.
Last verified 2026-09-29 · how we verify
CJC-1295 elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration · 2026-08-06 · accessed 2026-09-29
- 03Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29