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CJC-1295 Compounding Pharmacy: How to Read a Certificate of Analysis

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11 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA approval / none, in any country FDA searched [1]
  • USP monograph / none [2][3]
  • FDA bulk-substance lists / not in any category; nomination withdrawn [4][2]
  • Advisory committee vote / 0 yes, 13 no on CJC-1295 free base [5]
  • Forms to distinguish / CJC-1295 and CJC-1295 DAC [1]
  • Published human studies / three, all DAC form, healthy volunteers only [1]
  • WADA status / named in S2.2.4, prohibited at all times [6]

Is there a public standard for a CJC-1295 certificate of analysis?

No. CJC-1295 is not a component of an FDA-approved drug and has no USP monograph [2][3]. A certificate therefore shows what a laboratory reported for that batch, but it does not by itself establish FDA approval or that the batch meets a recognized compounding standard.

FDA also noted that CJC-1295 sold online is mostly labeled for research use only, including blends with ipamorelin and other growth hormone-releasing peptides, and that research-use-only products are not FDA-approved drugs [1].

What the regulatory record adds

CJC-1295 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians and is not on the list for outsourcing facilities [2][3]. It was placed in category 2, the significant-safety-risk group, but now sits in the nominated-but-withdrawn table after the nominators withdrew; FDA's stated concerns remain published [4].

In December 2024 FDA's Pharmacy Compounding Advisory Committee voted 0 yes, 13 no on CJC-1295 free base; 1 yes, 12 no on the acetate; and 0 yes, 13 no on each of the three DAC forms [5]. The October 2026 HHS enforcement-discretion draft covers six other peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500), not this one [7].

Which form does the report cover?

FDA describes two: CJC-1295, a 29-amino-acid growth hormone-releasing hormone analogue, and CJC-1295 DAC, the same peptide with an added maleimidopropionic acid-lysine unit at the C-terminal end that lets it bind blood albumin [1][8]. Because it binds albumin, its half-life is days rather than minutes [9][10]. A report that names only CJC-1295 does not say which form was tested. All three published human studies used the DAC form, and no trial tested the version sold as "CJC-1295 without DAC" [1][9].

What FDA says about the substance itself

FDA's safety-risk page still lists its reasons: possible immunogenicity for certain routes, impurity and characterization problems, serious adverse events including increased heart rate and systemic vasodilatory reaction, and limited clinical data [4].

The human record behind those words is small. FDA identified only three published human studies, all of the DAC form, all in healthy volunteers, and none in people with a disease [1]. FDA's briefing says the company withdrew CJC-1295 DAC from clinical trials in 2006 after a participant in a phase 2 trial in HIV lipodystrophy (192 enrolled) died. FDA cites news reports for the details, and the data were never published, so a causal link is neither shown nor excluded [1]. FDA said long-term safety is unknown because the studies were short, small and mostly single-dose [1].

Does a certificate change legal or sporting status?

No. WADA names CJC-1295 in S2.2.4 as a growth hormone-releasing hormone analogue, prohibited at all times in and out of competition, and names it again in the 2027 list [6][11]. A purity result does not alter that, and it does not place the peptide on any FDA compounding list [2][3].

Frequently asked questions

Does a certificate of analysis mean CJC-1295 is approved?
No. CJC-1295 is not an FDA-approved drug, and FDA found no approved product containing any form of it in the countries it searched [1]. A CoA is a batch report from a laboratory, not a regulatory approval.
What should a CJC-1295 CoA say about the form?
Which form was tested. FDA describes CJC-1295 and CJC-1295 DAC, the same peptide with an added unit that lets it bind albumin and last much longer [1][8]. A document naming only CJC-1295 does not distinguish them.
Is CJC-1295 on FDA compounding lists?
No. It is in none of the three categories on FDA's list for state-licensed pharmacies and physicians and is not on the outsourcing-facility list [2][3]. It was in category 2 but now sits in the nominated-but-withdrawn table, with FDA's concerns still posted [4].
Is CJC-1295 banned in sport?
Yes. WADA names it in S2.2.4 as a growth hormone-releasing hormone analogue, prohibited at all times, in and out of competition, and names it again in the 2027 list [6][11].

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. 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
  5. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  6. World Anti-Doping Agency. World Anti-Doping Agency
  7. Official web page. Official web page
  8. 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
  9. Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799-805. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults
  10. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog
  11. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for CJC-1295 Compounding Pharmacy: How to Read a Certificate of Analysis