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Thymosin alpha-1: FDA & compounding status

FDA approvalNot approved in the US
503A pharmacy (bulks list / category)No pathway. Committee voted 4-17 against
FDA Category 2 safety-risk listNot in current Category 2; listed by FDA under 'nominated but withdrawn' (FDA page current as of Apr 22, 2026). Leaving Category 2 does not authorize compounding. 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 3 (not eligible)
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
2024-12-04PCAC voted 4-17 againstsource

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.