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Ipamorelin: FDA & compounding status

FDA approvalNot approved
503A pharmacy (bulks list / category)No pathway. Committee voted 0-12 against, Oct 2024
FDA Category 2 safety-risk listIpamorelin acetate: in current 503B Category 2 since Sep 29, 2023; also appears under 'nominated but withdrawn' (FDA page current as of Apr 22, 2026) source
503A bulks list (21 CFR 216.23)Not listed. As of the eCFR text read Oct 20, 2026 the list holds six substances, none a peptide source
503B outsourcing503B Category 2 (acetate)
WADA 2026 Prohibited ListProhibited: S2.2.4 GH secretagogues (named), at all times source

FDA approval, 503A pathway and 503B cells: secondary source source, not yet checked against primary FDA records. Category 2, 216.23 and WADA cells: primary sources.

Timeline

DateEventSource
2024-10PCAC voted 0-12 againstsource
2026-08-24FDA warning letter naming an ipamorelin blendsource

Not medical or legal advice. PeptideStatus summarizes public regulatory sources for education only. It does not recommend using any substance. Rules change and vary by state. Talk to a licensed clinician and counsel. Status data verified only as of the source dates shown; Oct 19, 2026 build.