CJC-1295: A Withdrawal, Not a Clearance

What happened

The FDA's interim policy on compounding with bulk drug substances sorts nominated substances into two categories: Category 1 holds substances under review without identified safety concerns, which pharmacies may compound while the review continues, and Category 2 holds substances with significant safety concerns, which they may not ^[2].

In September 2024 CJC-1295 left Category 2. It left because the parties who had nominated it withdrew the nomination, and it was not added to Category 1. A substance whose nomination is withdrawn does not move from one category to the other; it leaves the process altogether. Ipamorelin's 503A nominations were withdrawn the same month, and this index files both under the same disposition; ipamorelin acetate, unlike CJC-1295, is still named in Category 2 under FDA's separate 503B policy for outsourcing facilities — the nomination tracker shows the four dispositions side by side.

The compound was not among the peptides the Pharmacy Compounding Advisory Committee reviewed at its July 2026 meeting ^[3]. Where the six recommended peptides at least hold an advisory vote pointing somewhere, CJC-1295 holds nothing pending at all.

Why this reads as good news and is not

Removal from a list titled after safety concerns has an obvious surface reading, and the market has taken it: the departure is regularly reported as a clearance, a de-restriction, or a signal that the agency's objections were dropped. None of those describes what occurred.

The arithmetic is simple and it is worth stating in one line. No listing, no approval, no lawful compounding route. A licensed 503A pharmacy may compound from a bulk substance only where the substance appears on the relevant list or is the subject of an approved product; CJC-1295 satisfies neither condition, and the withdrawal removed the mechanism by which it might have come to satisfy the first.

The research-only page sets out both paths that lead to this position — removal without review, and withdrawal — and why neither is permission.

The evidence that makes the position unusual

What distinguishes CJC-1295 from most of the research-peptide market is that it reached formal clinical study. In a randomized, placebo-controlled study in healthy adults, single injections raised growth hormone concentrations two- to ten-fold for six days or more and insulin-like growth factor 1 concentrations 1.5- to three-fold for up to eleven days, with an estimated half-life of 5.8 to 8.1 days ^[1].

Development did not continue to approval, and no efficacy trial in any indication followed. The pharmacokinetic result is therefore the whole of the human record: a demonstration that the molecule does what it was designed to do to the growth hormone axis, and no demonstration that doing so benefits anyone. A later study found that the natural growth hormone pulses survive the compound's long action; CJC-1295 with ipamorelin reads that study and the rest of the human record.

The class context is on the GH secretagogues page, where the same class holds an approved drug, a lawfully compoundable molecule, and this withdrawn pair; the monograph carries the dated ledger.

What is sold under the name

Because no lawful route exists, material offered as CJC-1295 is research-use-only chemical supply, sold outside pharmacy licensure and outside the quality obligations that attach to a drug. The glossary sets out what that labeling posture means and, more usefully, what it does not.

Elsewhere in this index