CJC-1295 Legal Status: FDA Approval and Compounding Rules

What CJC-1295 is

CJC-1295 is an investigational long-acting analogue of growth hormone-releasing hormone (GHRH), developed by ConjuChem Biotechnologies of Montreal and first described in 2005 [1][7]. FDA describes two forms: the 29-amino-acid peptide, and CJC-1295 DAC, which carries an extra lysine unit that lets it bind blood albumin and last far longer [1]. FDA identified only three published human studies, all of the DAC form in healthy volunteers; no trial tested the version sold without DAC [1].

No FDA approval and no federal compounding category

In December 2024 FDA found no approved product containing any form of CJC-1295 in the 12 countries it searched (Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Norway, Spain and the United Kingdom), and none authorized by the European Medicines Agency [1].

FDA's list of bulk drug substances for state-licensed pharmacies and physicians (updated May 14, 2026) sorts substances into three categories, and CJC-1295 is in none of them. It is not on FDA's list for outsourcing facilities (updated March 21, 2025), is not a component of an FDA-approved drug and has no USP monograph [2][3]. FDA's category 1 policy, under which it generally takes no action against compounders that meet the conditions, therefore does not apply [2].

The December 2024 committee vote

FDA's reviewers proposed that no form of CJC-1295 be added to the pharmacy bulks list. On December 4, 2024, FDA's Pharmacy Compounding Advisory Committee voted 0 yes and 13 no on the free base, 1 yes and 12 no on the acetate, and 0 yes and 13 no on each of the three DAC forms [4]. CJC-1295 is also not one of the six peptides in HHS's October 2026 draft enforcement-discretion policy (BPC-157, epitalon, KPV, MOTS-c, Semax, TB-500), and no FDA or HHS action allowing its compounding has been identified [8].

What FDA says about safety

CJC-1295 was once in category 2 of FDA's interim policy on bulk substances that may present significant safety risks; it now sits in the nominated but withdrawn table because the nominators withdrew [5]. FDA's concerns remain posted: possible immunogenicity for certain routes, impurity and characterization problems, 'serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction', and the statement that available clinical data are limited [5].

Vials sold online, and sport

FDA noted that CJC-1295 products sold online are mostly labeled research use only, including blends with ipamorelin and other GHRPs, and that CJC-1295 has been found in illicit sports use; research-use-only products are not FDA-approved drugs [1]. WADA names CJC-1295 in section S2.2.4 as a growth hormone-releasing hormone analogue, prohibited at all times, in and out of competition [6].