top of page
Gavin Canzanese
Writer
More actions
Profile
Join date: Mar 31, 2024
Posts (2)
Jan 26, 2026 ∙ 10 min
How Ozempic Exposed the Limits of the FDCA’s § 503A Compounding Framework
[1] Semaglutide drugs, sold under the brand names Ozempic and Wegovy, saw a substantial increase in use for treating diabetes and obesity, driving nationwide shortages. [2] During the shortage, the FDA’s drug-shortage-list policies allowed compounding to expand as a practical substitute for the approved products. [3] Background Pharmacies compound patient-specific drugs when a suitable commercial product is unavailable. [4] Under § 503A of the Food, Drug, and Cosmetic Act (“FDCA”),...
54
0
Apr 2, 2024 ∙ 5 min
Dormant For a Reason: A Look at March-In Rights
Photograph of the U.S. Capital Building [1] On December 8th of 2023, controversy struck when the National Institute of Standards and...
217
0
bottom of page
