# CJC-1295 Standing Protocol — Verification Memo
**Date:** 2026-05-13
**Author:** Joshua Hare, DO
**Status:** ACTION REQUIRED — replace CJC-1295 in standing protocol

## Finding

CJC-1295 (No DAC) is **not currently a legal compounded substance for human use in 2026**, despite the April 23, 2026 reclassification that restored several other peptides. This was verified against three independent primary/regulatory sources on 2026-05-13:

1. **FDA Law Blog (Hyman, Phelps & McNamara), April 2026:** CJC-1295 was removed from Category 2 and referred to PCAC for further evaluation following the AOD-9604 / CJC-1295 / Ipamorelin / Thymosin Alpha-1 litigation. Even if PCAC recommends inclusion, **notice-and-comment rulemaking is still required — a process that typically takes more than a year. These regulatory statuses persist making it illegal to produce these unapproved peptides for human consumption until the conclusion of formal rulemaking.**

2. **FDA July 23–24, 2026 PCAC agenda (official):** CJC-1295 is **NOT on the docket.** The four peptides being reviewed on July 23 are BPC-157, KPV, TB-500, and MOTS-c. Day two: Emideltide (DSIP) and Semax. No GH secretagogue agenda item.

3. **PeptideWiki / PeptideBond regulatory trackers:** Concur — "Growth hormone secretagogues (CJC-1295, Ipamorelin, GHRP-2, GHRP-6, Hexarelin) face the steepest path for reclassification. CJC-1295 remains classified as a developmental drug and is not legal for human compounding in 2026 regardless of other ongoing regulatory changes."

## Implication for Limitless

The standing peptide protocol on `feedback_peptide_protocols.md` lists "Ipamorelin + CJC-1295 No DAC" as the default GH secretagogue pairing on every patient lab report. **This pairing should not appear on new reports as written.**

## Recommended replacement

The cleanest substitution that preserves Dr. Hare's clinical intent (GH-axis support via GHRH analog or secretagogue) without compliance exposure:

**Default GH-axis recommendation, revised:**
- **Tesamorelin** (FDA-approved GHRH analog, 1–2 mg SubQ daily) — already in the standing stack for visceral-adiposity indication; broaden to "GH-axis lead" where indicated.
- **Ipamorelin** as standalone secretagogue (200–300 mcg SubQ pre-sleep) where appropriate — note: Ipamorelin is in the same regulatory queue as CJC-1295 (PCAC pending; not yet on a confirmed 503A bulks shelf), so this is itself a conditional placement and should be cross-checked with the 503A partner pharmacy formulary before any new report.
- **Sermorelin** (historically FDA-approved GHRH analog, now compounded by 503A under longer-standing precedent) as an alternative GHRH analog where tesamorelin is not indicated.

## Pages and files that need to be swept

Each location below currently contains CJC-1295 references that should be reviewed and (probably) revised by Dr. Hare:

- `/_deploy/peptides.html` — public peptide menu page
- `/_deploy/portal-peptides.html` — patient portal peptide module
- `/_deploy/peptide-program.html` — program overview
- `/_deploy/peptide-therapy-dalton-ga.html` / `/peptide-therapy-north-georgia.html` — local SEO pages
- `/_deploy/peptides-legal-2026.html` — legal-status briefing (may already address this; review)
- Python lab-report PDF generator — search source for `CJC` or `1295` and review the default recommendation block
- Memory: `feedback_peptide_protocols.md` — update standing order

## Why I did not auto-rewrite the public pages

Rewriting the public peptide menu and patient-facing protocol statements without Dr. Hare's eyes on the substitution would be the wrong call — the choice between tesamorelin-as-lead, sermorelin alternative, and Ipamorelin-conditional is a clinical decision that should be made by the prescribing physician, not auto-applied. This memo flags the operational change required and proposes a substitution; the actual rewrite should be a single short working session with Dr. Hare to confirm the language patient-facing and on the lab report template.

## Suggested next step

A 20-minute review session: (a) confirm the tesamorelin-lead / sermorelin-alt / Ipamorelin-conditional substitution, (b) sweep the seven file locations above with the confirmed language, (c) update the standing-order memory.

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*Status will be re-evaluated and this memo updated after the July 23, 2026 PCAC meeting and again whenever the FDA publishes a final rule affecting any GH-axis compounded substance.*