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Sermorelin: FDA & compounding status

FDA approvalFormerly approved (Geref); withdrawn 2009, not for safety
503A pharmacy (bulks list / category)Compounded as approved-drug component (caveats apply)
FDA Category 2 safety-risk listNot on FDA's Category 2 safety-risk page (current as of Apr 22, 2026). Category 1/3 status: Unknown (not yet verified) 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 1 (acetate)
WADA 2026 Prohibited ListProhibited: S2.2.4 GHRH analogues (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
2024-12-10FDA warning letter on 'research' sermorelinsource

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.