| FDA approval | Approved (Ozempic, Rybelsus, Wegovy, Wegovy tablets) |
|---|---|
| 503A pharmacy (bulks list / category) | Component of an approved drug, limited by FDA 'essentially a copy' rules |
| 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 | No bulk pathway; exclusion proposed May 2026 |
| WADA 2026 Prohibited List | Not named in 2026 List (approved medicine, so S0 does not apply) 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 |
|---|---|---|
| 2026-03-03 | FDA warning letters to 30 telehealth firms | source |
| 2026-05-01 | Proposal to exclude from 503B bulks list (91 FR 23431) | 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.