CJC-1295 Compounding Legal Status: What the FDA Actually Says

Is CJC-1295 an approved drug?

No. FDA looked for approved products containing any form of CJC-1295 in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Norway, Spain and the United Kingdom and found none, and found none authorized by the European Medicines Agency [1]. 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][8].

FDA describes two forms: CJC-1295, a 29-amino-acid GHRH analogue, and CJC-1295 DAC, the same peptide with an extra maleimidopropionic acid-lysine unit at the C-terminal end — the drug affinity complex — that lets it bind albumin in blood and last much longer [1][8]. The 2005 rat study that identified it describes a tetrasubstituted form of GHRH(1-29) with that added lysine unit, detectable in rat plasma beyond 72 hours [8].

Sermorelin is a different drug. Sermorelin was once approved as Geref, which was withdrawn in 2009; no form of CJC-1295 has ever been approved anywhere FDA searched [1].

What has FDA actually said about compounding it?

Several FDA documents matter, and they do not all say the same thing.

The safety-risk page: nominated, then withdrawn

FDA's page on bulk substances that may present significant safety risks, with content dated 04/22/2026, lists CJC-1295 in the table of substances that were nominated but withdrawn. It had been placed in category 2; the nominators withdrew their nominations, and it came off that list [6].

The safety concerns did not come off with it. The same page still lists possible immunogenicity for certain routes of administration, impurity and characterization problems, serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction, and the fact that available clinical data are limited [6].

FDA's lists for pharmacies and outsourcing facilities

FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026, sorts bulk substances into three categories. CJC-1295 is in none of them [2]. It is also absent from FDA's list for outsourcing facilities, updated March 21, 2025 [3].

It is not a component of an FDA-approved drug and it has no USP monograph [2][3]. FDA's category 1 policy, under which the agency generally does not intend to take action against compounders that meet its conditions, therefore does not apply to CJC-1295 [2][3].

The December 2024 advisory committee vote

FDA's reviewers proposed that none of the CJC-1295 forms be added to the pharmacy bulks list. On December 4, 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 [4].

Does the October 2026 HHS peptide policy cover CJC-1295?

No. HHS's October 2026 draft enforcement-discretion policy names six peptides — BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 — and CJC-1295 is not one of them [5].

What human data does FDA cite?

FDA identified three published human studies of CJC-1295, all of the DAC form and all in healthy volunteers: Teichman 2006, Ionescu and Frohman 2006, and Sackmann-Sala 2009 [1]. No trial tested the version sold as CJC-1295 without DAC, and no trial showed a health benefit [1][9].

Teichman 2006 ran two randomized, placebo-controlled, double-blind, ascending-dose trials of 28 and 49 days in healthy adults aged 21 to 61, with single doses in the first study and two or three weekly or biweekly doses in the second [9]. After a single subcutaneous injection, mean plasma GH rose 2- to 10-fold for 6 days or more and mean IGF-I rose 1.5- to 3-fold for 9 to 11 days, with an estimated half-life of 5.8 to 8.1 days; after multiple doses, IGF-I stayed above baseline for up to 28 days, and no serious adverse reactions were reported [9].

Ionescu and Frohman 2006 gave healthy men aged 20 to 40 one injection of 60 or 90 micrograms/kg. A week later GH pulsatility was preserved, trough GH was up about 7.5-fold, mean GH up 46% and IGF-I up 45%, with no difference between the two doses [10].

Teichman's adverse events, as FDA summarizes them: injection-site reactions in about 70% of treated subjects in study 1 and in all treated subjects in study 2; headache in 63% versus 14% on placebo in study 1; flushing, warmth and transient low blood pressure in about 30% of treated subjects in study 1; transient diarrhea; and transient dizziness and low blood pressure in two subjects. Most events were more common at the higher doses of 125 or 250 micrograms/kg, and no serious adverse reactions were reported [1][9].

The phase 2 trial that was stopped

ConjuChem withdrew CJC-1295 DAC from clinical trials in 2006 after a participant in a phase 2 trial in HIV lipodystrophy, which had enrolled 192 people, died. FDA cites anecdotal news reports that the person had chest discomfort 2 hours after an 11th weekly dose, that an ECG showed an acute heart attack, and that the attending physician's most likely explanation was undiagnosed coronary artery disease with plaque rupture. The data were never published, so a causal link is neither shown nor excluded [1]. A trial in HIV-associated visceral obesity listed as NCT00267527 was terminated [1].

Is there an approved dose?

No. There is no FDA-approved dose of CJC-1295 [1]. The doses used in the human studies of the DAC form in healthy adults were single subcutaneous injections of about 30 to 250 micrograms/kg, or two or three doses given weekly or every two weeks; they are not recommended doses [1][9].

What are FDA's stated safety concerns about raising GH?

CJC-1295 DAC acts like GHRH on the pituitary to raise the body's own growth hormone and, through GH, IGF-I; because it binds albumin, its half-life is days rather than minutes [9][10]. FDA's stated concern is that GH and IGF-I elevation carries the risks listed on approved growth hormone labels, such as glucose intolerance and diabetes, fluid retention and tumor growth concerns, and that the human studies were short, small and mostly single-dose, so long-term safety is unknown [1].

What actually gets sold as CJC-1295

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]. No FDA-approved label or package insert exists for any form of CJC-1295 [1].

WADA's 2026 Prohibited List names CJC-1295 and CJC-1293 in S2.2.4 as growth hormone-releasing hormone analogues, prohibited at all times, in and out of competition; S2 substances are non-Specified Substances. It is also named in the 2027 List, in force January 1, 2027 [7][11].

What this means for a CJC-1295 prescription

FDA's documents show no approved product anywhere it looked, no category on either federal list, and a reviewer recommendation against adding it [1][2][3][4]. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they reach patients [12].