FDA compounding status
Ipamorelin acetate
Also listed as Ipamorelin.
Ipamorelin is not FDA-approved, and there is no pathway for a US pharmacy or a 503B outsourcing facility 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 FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on October 29, 2024. Ipamorelin acetate is still in FDA's 503B Category 2, the category for substances that may present significant safety risks.
Covers ipamorelin free base and ipamorelin acetate, the two forms FDA's advisory committee reviewed. FDA's 503B Category 2 entry names ipamorelin acetate.
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, Oct 29, 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 ipamorelin acetate 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FDA's 503A categories document of September 27, 2024 removed ipamorelin from Category 2 after its nominations were withdrawn. At its October 29, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against each form, with one abstention, according to the final minutes. FDA placed ipamorelin acetate in 503B Category 2 on September 29, 2023, and it remains there in the 503B categories document of March 21, 2025. 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 a published report of serious adverse events, including death, when ipamorelin was given intravenously for gastric motility, and says FDA lacks sufficient information on other injectable routes. FDA's warning letter of August 24, 2026 to an online peptide seller named a tesamorelin and ipamorelin blend among unapproved new drugs.
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, October 29, 2024: final minutesDocument dated . Checked .
- FDA warning letterWarning letter 734884, Royal Peptides LLCDocument 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 October 29, 2024, according to the final minutes.
Pharmacy Compounding Advisory Committee, October 29, 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
Ipamorelin acetate, answered plainly.
- What is the FDA compounding status of Ipamorelin acetate?
- Ipamorelin is not FDA-approved, and there is no pathway for a US pharmacy or a 503B outsourcing facility 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 it on October 29, 2024. Ipamorelin acetate is still in FDA's 503B Category 2, the category for substances that may present significant safety risks.
- What does the status of ipamorelin acetate trace to?
- FDA's 503A categories document of September 27, 2024 removed ipamorelin from Category 2 after its nominations were withdrawn. At its October 29, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against each form, with one abstention, according to the final minutes. FDA placed ipamorelin acetate in 503B Category 2 on September 29, 2023, and it remains there in the 503B categories document of March 21, 2025. 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 a published report of serious adverse events, including death, when ipamorelin was given intravenously for gastric motility, and says FDA lacks sufficient information on other injectable routes. FDA's warning letter of August 24, 2026 to an online peptide seller named a tesamorelin and ipamorelin blend among unapproved new drugs. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of ipamorelin acetate?
- 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 ipamorelin acetate?
- PEPLUX offers ipamorelin acetate as CJC-1295 and Ipamorelin. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Ipamorelin acetate 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 ipamorelin acetate prohibited in sport?
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).