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Ipamorelin
503A/503B Category 2
as of October 2026
By Stephen Kimball, 26+ years researching the health, wellness, supplement, and peptide industries
As of October 2026, ipamorelin isn’t approved for any use and can’t be legally compounded. It shows up twice on FDA’s safety-risk page, and that’s intentional: the nomination for regular compounding pharmacies was withdrawn, but ipamorelin is still on the safety-risk list for larger “outsourcing facility” compounders. FDA cites a published study in which serious adverse events, including death, occurred when it was given intravenously, and says it lacks safety information for other injectable routes. It’s often sold combined with CJC-1295 by “research use only” sites and some clinics.
Also see our full article on Ipamorelin: What it is, how it works.
Sources
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 table, 503B; and withdrawn table)
U.S. Food & Drug Administration
dated Apr 2026
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (categories list — ipamorelin absent from Categories 1 and 2)
U.S. Food & Drug Administration
dated May 2026
Change log
Sep 29, 2023
FDA places ipamorelin acetate in Category 2 under the 503B interim policy.
Late 2023
Also placed in 503A Category 2.
Apr 2026
503A nomination withdrawn; ipamorelin moves to the “nominated but withdrawn” table while remaining in 503B Category 2, per FDA’s note on the page.