Compounding is legal when a state-licensed 503A pharmacy prepares a patient-specific prescription, or an FDA-registered 503B outsourcing facility compounds under cGMP. What changed: during the 2022–2025 shortage, large-scale compounding of semaglutide was broadly permitted. After the FDA declared the semaglutide shortage resolved in 2025, that broad allowance narrowed, and enforcement tightened.
Compounded semaglutide is not FDA-approved as a finished product, is not reviewed for safety, potency, or quality, and is not an FDA-approved generic. If you use it, verify the pharmacy’s license and 503A/503B status first. Legality and availability vary — confirm current status before purchase.