CJC-1295 Compounding Pharmacy FDA and State Board Enforcement History

What FDA did with CJC-1295

FDA's reviewers proposed in December 2024 that none of the CJC-1295 forms be added to the pharmacy bulks list [1]. On 4 December 2024 the Pharmacy Compounding Advisory Committee voted 0 yes and 13 no on CJC-1295 free base, 1 yes and 12 no on CJC-1295 acetate, and 0 yes and 13 no on each of the three DAC forms [1].

CJC-1295 falls into none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated 14 May 2026) and is absent from the list for outsourcing facilities (updated 21 March 2025) [3][4]. It is not a component of an FDA-approved drug and has no USP monograph, so FDA's category 1 policy, which generally means no action against compounders that meet its conditions, does not reach it [3][4].

Where the safety concerns come from

CJC-1295 was previously in category 2, the group FDA flags as presenting significant safety risks. It now sits in the nominated-but-withdrawn table because the nominators withdrew, while FDA's stated concerns remain posted: possible immunogenicity for certain routes, impurity and characterization problems, serious adverse events including increased heart rate and systemic vasodilatory reaction, and limited clinical data [5].

ConjuChem, the Montreal company that developed the peptide, withdrew the DAC form from clinical trials in 2006 after a participant in a phase 2 trial in HIV lipodystrophy (192 enrolled) died [2]. FDA cited anecdotal news reports that the participant had chest discomfort two hours after an 11th weekly dose and that an ECG showed an acute heart attack; the attending physician's most likely explanation was undiagnosed coronary artery disease with plaque rupture [2]. The data were never published, so a causal link is neither shown nor excluded [2].

FDA identified three published human studies, all of the DAC form and all in healthy volunteers, and found none in people with a disease [2]. It noted that raising growth hormone and IGF-I carries the risks listed on approved growth hormone labels, including glucose intolerance and diabetes [2]. CJC-1295 sold online is mostly labeled research use only, including blends with ipamorelin and GHRPs, and the peptide has appeared in illicit sports use; research-use-only products are not FDA-approved drugs [2].

State-licensed pharmacies

CJC-1295 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it sits outside the category 1 no-action policy [3][4]. No FDA or HHS action allowing compounding of CJC-1295 has been found, and the October 2026 HHS draft policy does not name it [6].