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Retatrutide: FDA & compounding status

FDA approvalInvestigational (Eli Lilly)
503A pharmacy (bulks list / category)No pathway; FDA says it cannot be compounded
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 outsourcingNone
WADA 2026 Prohibited ListNot named in 2026 List. S0 catch-all covers substances with no government approval for human use anywhere; whether it applies is Unknown (check with your anti-doping body) 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
2026-08-24FDA warning letter to Peptide Partnerssource

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.