| FDA approval | Not approved |
|---|---|
| 503A pharmacy (bulks list / category) | No pathway. In no category since Apr 22, 2026 |
| FDA Category 2 safety-risk list | Not in current Category 2; listed by FDA under 'nominated but withdrawn' (FDA page current as of Apr 22, 2026).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 outsourcing | None |
| WADA 2026 Prohibited List | Prohibited: S2.3 (thymosin-beta4 derivatives, 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.
| Date | Event | Source |
|---|---|---|
| 2026-04-22 | Removed from Category 2 (nominations withdrawn) | source |
| 2026-07-23 | PCAC voted to recommend listing (trade-press report); nonbinding | source |
| 2026-10-15 | HHS interim access policy sent to OMB; scope not public | source |
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.