FDA Approval Status
FDA-approved as Ozempic (type 2 diabetes, 2017), Wegovy (chronic weight management, 2021), and Rybelsus (oral, type 2 diabetes, 2019). Compounded semaglutide was permitted during shortage but FDA declared shortage resolved in March 2025.
Compounding Pharmacy Rules (Federal)
Compounding of semaglutide was broadly permitted under shortage exemptions through early 2025. Following FDA's March 2025 shortage resolution declaration, 503B outsourcing facilities had a wind-down period through April 2025, and 503A pharmacies through May 2025. As of mid-2025, compounded semaglutide is generally prohibited except for specific patient needs (e.g., documented allergy to an inactive ingredient in the commercially available product) under a valid prescription.
Also Known As
Ozempic · Wegovy · Rybelsus
Primary Research Areas
- Weight management
- Type 2 diabetes
- Cardiovascular risk reduction
- Metabolic health