# CJC-1295 Legal — The federal, anti-doping, and compounding rules that govern a long-acting GHRH analog > A plain-English reading of the federal, anti-doping, and pharmacy-compounding rules that govern CJC-1295: FDA status, the December 2024 PCAC vote, WADA prohibition, DEA scheduling, DSHEA exclusion, and the import regime. Five agencies, eight statutes, one peptide that has never had an approved application. What follows is a plain-English reading of the law as it actually sits — not legal advice, and not a sales page. ## The short version CJC-1295 is a synthetic analog of a hormone your brain makes to tell the pituitary to release growth hormone (GH). It was engineered to last days in the body rather than minutes, by latching it to a blood protein called albumin. A Phase 1 study in 2006 confirmed it raised GH and IGF-1 for up to a week from a single dose. After that, development stopped — a Phase 2 trial was discontinued, and no drug application was ever filed. In December 2024, an FDA advisory committee voted not to allow it to be compounded by pharmacies. WADA bans it for all athletes at all times. This site reads the statutes, briefing documents, and peer-reviewed papers that produced that posture. It does not sell anything, prescribe anything, or give legal advice. For reported effects and safety signals, see the [effects page](/effects). ## What CJC-1295 is, and why its legal status is unusually layered The first thing to understand about CJC-1295 is that it is not a drug in the regulatory sense of that word. It is a 30-amino-acid synthetic analog of growth hormone-releasing hormone, built on the first 29 residues of human GHRH with four amino acid substitutions and — in the long-acting variant — a maleimide tether that covalently binds the free thiol on Cys34 of circulating serum albumin, extending its plasma half-life from minutes to days [1][3]. It was characterized in rats in 2005, taken through a small Phase 1 program in healthy adults in 2006, and then carried into a Phase 2 trial in HIV-associated visceral adiposity that was terminated the same year [1][2][7]. No New Drug Application or Biologics License Application has ever been filed for it. There is no FDA-approved labeling, no approved indication, and no approved manufacturer. Every U.S. statute and regulation that touches CJC-1295 therefore reaches it through a different doorway — none of them through the doorway marked *approved drug*. That is the unusual part. Most compounds that show up in plain-English explainers are either approved (which gives you a label, an indication, and a clear set of rules) or controlled (which gives you a DEA schedule and the criminal penalties that attach to it). CJC-1295 is neither. It sits in a regulatory zone constructed out of the Federal Food, Drug, and Cosmetic Act, the Dietary Supplement Health and Education Act, the World Anti-Doping Code, the NCAA banned-substance list, the Department of Defense supplement policy, and — at the state level — pharmacy-board licensure regimes. This site is a reading of that zone. ## Five jurisdictions, briefly **FDA.** CJC-1295 has never been approved for any human indication. In 2023 the agency placed it in Category 2 of the interim 503A bulks list, meaning it identified significant safety concerns and did not permit it for traditional pharmacy compounding [12]. In September 2024 the nominators withdrew the nomination [12]. On December 4, 2024, the Pharmacy Compounding Advisory Committee voted in agreement with FDA's recommendation against inclusion on the final 503A bulks list — citing nonclinical toxicity (DNA damage in pituitary cells, injection-site necrosis), the unresolved cardiac signal from the 2006 trial termination, and immunogenicity risk [13]. CJC-1295 is not on the 503A list, not on the 503B list, has no USP/NF monograph, and is not a component of any FDA-approved drug product. **WADA.** Listed under Section S2.2.4 of the 2025 Prohibited List as a growth hormone-releasing factor, prohibited at all times — in and out of competition — under strict liability for any athlete subject to the Code [11]. Detection is validated to picogram-per-milliliter concentrations [10], and samples may be retained for retrospective analysis for up to ten years. **DEA.** Not scheduled under the Controlled Substances Act. CJC-1295 does not appear in any of the five DEA schedules; possession is not a CSA offense [17]. The lead federal enforcement agency is FDA, not DEA. **DSHEA.** Excluded from the definition of a dietary supplement under 21 U.S.C. § 321(ff)(3)(B), because CJC-1295 was the subject of substantial public clinical investigation as a new drug [19]. Marketing it as a supplement is treated by FDA as marketing of an unapproved new drug. **Imports.** Reachable under FDCA Section 801(a). FDA Import Alerts (notably 66-41 for unapproved finished drugs and 99-32 for misbranded drugs) authorize field staff to detain CJC-1295 shipments without physical examination [18]. Vendor labels that read *for research use only* do not, on their own, defeat this authority when other evidence points to intended human use [15]. ## The single most-misread statute: 21 U.S.C. § 333(e) If you read enough peptide forum posts, you will eventually encounter the claim that selling CJC-1295 for non-medical human use is a five-year federal felony under the *human growth hormone* statute, 21 U.S.C. § 333(e). The claim is half right, in a way that matters. Section 333(e) defines *human growth hormone* as *somatrem, somatropin, or an analogue of either of them* [16]. Somatrem and somatropin are the recombinant forms of GH itself. CJC-1295 is not an analog of GH. It is a GHRH analog — that is, it acts one step upstream, at the pituitary GHRH receptor, prompting endogenous GH release [1][3]. Commentators on the statutory text generally read § 333(e) as not covering GHRH analogs on its face [16]. This does not mean distributing CJC-1295 for non-medical human use is unreachable under federal law. It very much is reachable — through the general unapproved-new-drug prohibitions of 21 U.S.C. §§ 331, 333(a), and 355, the misbranding provisions, and (for cross-border shipments) § 381(a) [15][18]. The point is narrower and more precise: § 333(e) is a different statute, with a different definitional reach, and conflating it with the general FDCA framework leads to bad analysis. That distinction is one of several this site is built to draw. ## What this site is, and what it is not **This site is an independent editorial project.** It publishes summaries of the peer-reviewed research literature, the FDA briefing documents, the WADA Prohibited List, and the underlying statutes that touch CJC-1295. Every regulatory claim on every page is attributed to its source — a statute, a regulation, a docket, a briefing document, or a peer-reviewed paper. **It is not a law firm.** We do not provide legal advice and we do not have an attorney-client relationship with anyone who reads these pages. If you have a specific legal question about your jurisdiction, your facility, your athletic eligibility, or your situation, talk to a lawyer admitted in your jurisdiction. **It is not a clinic.** We do not employ clinicians, we do not prescribe, we do not diagnose, and we do not provide medical advice. **It is not a vendor.** We do not manufacture, sell, distribute, recommend, or refer any product. We have no commercial relationship with any peptide supplier, compounding pharmacy, telehealth platform, or research-chemical company. With that established: the rest of this site is the regulatory record, read carefully. --- An independent editorial reading of the regulatory record — not legal advice, not medical guidance, not a vendor.