Is Semaglutide legal in United States?

Semaglutide is FDA-approved for type 2 diabetes (Ozempic injection, Ozempic and Rybelsus tablets) and, as Wegovy, for weight reduction and long-term weight maintenance, for reducing cardiovascular events in adults with heart disease plus obesity or overweight, and for non-cirrhotic MASH. Wegovy became available as a tablet after FDA approval on 22 December 2025. FDA declared the semaglutide injection shortage resolved on 21 February 2025, so the shortage-based compounding cover ended (April 2025 for 503A pharmacies and May 2025 for 503B outsourcing facilities). On 1 May 2026 FDA proposed not to put semaglutide on the 503B bulks list, and it says it knows of no lawful basis to compound semaglutide salt forms; 503A pharmacies may still not routinely make essentially-copy versions.