The short answer. CJC-1295 is not FDA-approved and, as of September 25, 2026, has no compounding pathway in any form. On December 4, 2024 FDA’s advisory committee voted against listing all five forms it reviewed, with and without DAC.
| FDA approved | No. Not a component of any approved drug. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category. |
| 503B outsourcing facility | No pathway. |
| Latest FDA action | Advisory committee, Dec 4, 2024: 0-13 on four forms, 1-12 on the acetate. |
| Sport | WADA prohibited (S2.2.4, GHRH analogues). |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-25 |
The committee voted on every form operators ask about
FDA reviewed five forms on its own initiative after the nominations were withdrawn in September 2024. The committee voted on each separately.
| Form | Vote (yes-no) |
|---|---|
| CJC-1295 free base (no DAC) | 0-13 |
| CJC-1295 acetate (no DAC) | 1-12 |
| CJC-1295 with DAC, free base | 0-13 |
| CJC-1295 with DAC, acetate | 0-13 |
| CJC-1295 with DAC, trifluoroacetate | 0-13 |
Pages that still describe CJC-1295 as nominated, withdrawn or under review are describing 2024 before December.
FDA’s safety concerns are specific
FDA’s safety-risk page cites serious adverse events including increased heart rate and a systemic vasodilatory reaction. Its December 2024 briefing notes that the DAC version was withdrawn from clinical trials in 2006 after a subject died. FDA named CJC-1295 as an ineligible substance in its 2020 warning letter to Tailor Made Compounding.
What this means for you
Take CJC-1295 off the menu in every form, including the ipamorelin stack. If a supplier distinguishes “no DAC” as the safer or permitted version, the committee record answers that directly: 1-12 and 0-13. For a growth hormone axis option, read the sermorelin page and talk to us about peptide programs.
Read next
Frequently asked questions
Is CJC-1295 without DAC legal to compound?
No. FDA’s advisory committee voted 0 to 13 against the free base and 1 to 12 against the acetate on December 4, 2024. Neither form is on the 503A bulks list or in any FDA category, and neither is part of an approved drug.
What is the difference between CJC-1295 with and without DAC?
DAC is a chemical attachment that binds the peptide to albumin and extends how long it lasts in the body. For regulatory purposes the distinction changes nothing: the committee voted against listing every form with and without DAC, by margins of 0 to 13 and 1 to 12.
Why does FDA consider CJC-1295 risky?
FDA cites serious adverse events including increased heart rate and a systemic vasodilatory reaction. Its 2024 briefing also notes the DAC version was withdrawn from clinical trials in 2006 after a trial subject died. FDA lists CJC-1295 on its page of bulk substances that may present significant safety risks.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- 21 CFR 216.23, the 503A bulks list
- FDA briefing document, CJC-1295 (Dec 2024 PCAC)
- FDA, PCAC minutes, Dec 4, 2024
- FDA warning letter, Tailor Made Compounding (Apr 1, 2020)
- WADA 2026 Prohibited List
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.