Semaglutide: Regulatory Status
Current legal and regulatory status for Semaglutide across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Semaglutide overviewUnited States
FDA Approved
Prescription required
Recent Regulatory Action
FDA confirmed semaglutide shortage resolved (February 2025), ending compounding pharmacy exemption for shortage-related production.
FDA-approved as Ozempic (T2D, 2017), Wegovy (chronic weight management, 2021), and Rybelsus (oral, T2D, 2019). Available generically through compounding pharmacies under 503A.
What This Means
Reclassification is not the same as FDA approval.
Even if Semaglutide moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.