Martha Rumore, PharmD, JD
Are glucagon-like peptide-1 (GLP-1) agonist drugs such as semaglutide and tirzepatide too complex for 503A and 503B compounders to manufacture “essential” copies, under the FDA’s rules governing compounding during declared drug shortages?
That’s the argument being made by semaglutide manufacturer Novo Nordisk, which on Oct. 22, 2024, filed a request that the agency add Wegovy products to the “Demonstrable Difficulties for Compounding [DDC]