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CJC-1295 Legal Status: FDA Approval and Compounding Rules

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Key numbers

  • 12 countriesCountries FDA searched where no approved product containing any form of this peptide was foundSource: fda.gov, as cited 2026-11-08
  • 13 noAdvisory committee votes against adding the free base form to the pharmacy bulks listSource: fda.gov, as cited 2026-11-08
  • 12 noAdvisory committee votes against adding the acetate form to the pharmacy bulks listSource: fda.gov, as cited 2026-11-08

At a glance

  • FDA approval / None; no approved product in the 12 countries FDA searched [1]
  • Pharmacy bulk-substance categories / In none of the three [2]
  • Outsourcing-facility list / Not listed [3]
  • Advisory committee vote / 0 yes, 13 no on the free base; 1 yes, 12 no on the acetate; 0 yes, 13 no on each DAC form [4]
  • FDA safety page / Nominated but withdrawn, with safety concerns still posted [5]
  • Sport / Prohibited at all times by WADA [6]

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].

Questions worth asking

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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].

Check what you know

3 quick questions. Pick an answer to see what this article says.

1. According to the article, what is CJC-1295?
2. Where does CJC-1295 currently sit in FDA's interim policy on bulk substances?
3. According to the article, when does WADA prohibit CJC-1295 in sport?

Score: 0 right, 0 of 3 answered

Frequently asked questions

Is CJC-1295 legal in California?
This page covers federal status only. CJC-1295 has no FDA approval and is in none of FDA's three pharmacy compounding categories or on its outsourcing-facility list [1][2][3].
Is CJC-1295 covered by the October 2026 HHS peptide policy?
No. The draft policy covers six other peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [8].
Did FDA consider adding it to the compounding list?
Yes. On December 4, 2024 its 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].
Can I buy CJC-1295 online?
Products sold online are mostly labeled research use only, and research-use-only products are not FDA-approved drugs [1]. WADA prohibits CJC-1295 at all times in sport [6].

What people actually ask

Why is CJC-1295 not FDA-approved?

CJC-1295 is an investigational drug, and FDA points to limited clinical data. FDA identified only three published human studies, all of the DAC form in healthy volunteers, and no trial tested the version sold without DAC. FDA's safety concerns, including serious adverse events with increased heart rate and systemic vasodilatory reaction, remain posted on its site.

Is CJC-1295 FDA-approved?

No. FDA found no approved product containing any form of CJC-1295 in the 12 countries it searched, and none has been authorized by the European Medicines Agency. FDA describes it as an investigational drug.

What are the FDA rules for compounding drugs?

FDA sorts bulk drug substances for state-licensed pharmacies into three compounding categories, and it also keeps a separate list for outsourcing facilities. CJC-1295 is in none of the three categories and is not on the outsourcing list, so FDA's category 1 policy, which generally takes no action against compounders that meet its conditions, does not apply.

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  5. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  6. World Anti-Doping Agency. World Anti-Doping Agency
  7. Jetté L, Léger R, Thibaudeau K, Benquet C, Robitaille M, Pellerin I, et al. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology. 2005;146(7):3052-8. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog
  8. Official web page. Official web page
Evidence overview for CJC-1295 Legal Status: FDA Approval and Compounding Rules