FDA compounding status
CJC-1295
CJC-1295, with or without DAC, is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against every form it reviewed on December 4, 2024. Nothing favorable is pending.
Covers CJC-1295 with and without DAC (drug affinity complex), in every form FDA reviewed: without DAC as free base and acetate, and with DAC as free base, acetate and trifluoroacetate.
Checked against the primary sources on .
The record
- FDA status
- No compounding pathway today.
- Compounding basis
- No compounding pathwayNo facility type may compound this substance today.
- FDA advisory committee
- Voted against, Dec 4, 2024
- Sport (WADA 2026)
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
- Offered by PEPLUX
- Yes, as CJC-1295 and Ipamorelin
- Checked on
Offered by PEPLUX
CJC-1295 and Ipamorelin
PEPLUX offers CJC-1295 as CJC-1295 and Ipamorelin. The product page covers what it is, its risks, and how prescribing and pricing work.
Basis
What this status traces to.
FDA's 503A categories document of September 27, 2024 removed CJC-1295 from Category 2 after its nominations were withdrawn. At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted against each form it reviewed, with and without DAC, according to the final minutes. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page cites serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction, and says available clinical data are limited.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated September 27, 2024Document dated . Checked .
- FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument dated . Checked .
- FDA advisory committee minutesPharmacy Compounding Advisory Committee, December 4, 2024: final minutesDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee voted against it at its meeting of December 4, 2024, according to the final minutes.
Pharmacy Compounding Advisory Committee, December 4, 2024: final minutes (dated )
If you are subject to anti-doping rules
Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
Common questions
CJC-1295, answered plainly.
- What is the FDA compounding status of CJC-1295?
- CJC-1295, with or without DAC, is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against every form it reviewed on December 4, 2024. Nothing favorable is pending.
- What does the status of CJC-1295 trace to?
- FDA's 503A categories document of September 27, 2024 removed CJC-1295 from Category 2 after its nominations were withdrawn. At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted against each form it reviewed, with and without DAC, according to the final minutes. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page cites serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction, and says available clinical data are limited. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of CJC-1295?
- Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
- Does PEPLUX offer CJC-1295?
- PEPLUX offers CJC-1295 as CJC-1295 and Ipamorelin. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. CJC-1295 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Is CJC-1295 prohibited in sport?
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).