CJC-1295 is not FDA-approved as a finished drug for any indication. It is not on FDA’s 503A Bulks List and not in Category 1. FDA added it to 503A Category 2 on September 29, 2023 and removed it on September 27, 2024 because the nominations were withdrawn by the nominators. The Pharmacy Compounding Advisory Committee (PCAC) voted against placing all five CJC-1295 forms on the Bulks List on December 4, 2024, as FDA had proposed. The April 15, 2026 changes moved other peptides, such as BPC-157 and TB-500, out of Category 2 and did not change CJC-1295’s status.
FDA’s interim policy extends enforcement discretion only to Category 1 substances, and CJC-1295 is not in Category 1.
International picture: CJC-1295 has never received marketing approval in any major regulatory jurisdiction (FDA, EMA, PMDA, Health Canada). Tesamorelin, a structurally related GHRH analog, did achieve FDA approval (2010) and EMA approval for HIV-associated lipodystrophy. Sermorelin (the unmodified GHRH(1-29) parent compound) was the active ingredient in Geref, an FDA-approved drug discontinued in 2008 for reasons FDA determined in 2013 were not safety or effectiveness; licensed 503A pharmacies compound it by prescription.
Gray-market vials labeled "CJC-1295" sold as research chemicals come without pharmaceutical-grade quality assurance, identity verification, or sterility guarantees. The "DAC vs. non-DAC" distinction is also frequently mishandled outside licensed compounding contexts.