Frier Levitt attorneys are featured in a Specialty Pharmacy Continuum article, “’A War Brewing’ Between GLP-1 Manufacturers and Compounders” by Gina Shaw. The article details Novo Nordisk, a semaglutide manufacturer, requesting on October 22, 2024, that the FDA add Wegovy products to the “Demonstrable Difficulties for Compounding (DDC) List.” Their argument? That GLP-1 drugs such as semaglutide and tirzepatide may be too complex for 503A and 503B compounders to manufacture “essential” copies of.
Drugs on the DDC list are considered not safe for compounding, and if Wegovy products are added to this list, they cannot be compounded, even if listed on the FDA’s drug shortage list.
Confusion around GLP-1 compounding has risen since the FDA removed tirzepatide from its drug shortage list in early October. “This created a lot of confusion among stakeholders, including 503A compounding pharmacies as well as 503B outsourcing facilities, but even more importantly, patients” we added.
To learn more about this brewing war, read the article here: https://www.specialtypharmacycontinuum.com/Online-First/Article/10-24/-A-War-Brewing-Between-GLP-1-Manufacturers-and-Compounders/75306