| FDA approval | Approved (Egrifta); regulated as a biologic since Mar 23, 2020 |
|---|---|
| 503A pharmacy (bulks list / category) | No pathway; biologics are outside 503A |
| FDA Category 2 safety-risk list | Not 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 outsourcing | None |
| WADA 2026 Prohibited List | Prohibited: 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.
| Date | Event | Source |
|---|---|---|
| 2020-03-23 | Transitioned to biologic | source |
| 2026-08-24 | Warning letters to five research-peptide sellers | 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.