Will FDA deadlines reduce compounded versions of Ozempic?

 With a FDA deadline set for March 26 to stop compounding versions of Zepbound, followed by restrictions on compounded Ozempic and Wegovy set for later this spring, the agency is meeting resistance from telehealth companies and compounding pharmacies that are continuing to offer knockoff versions of the drugs, The Wall Street Journal reported March 19. 

Hims & Hers Health has said it will keep providing compounded versions of Ozempic and Wegovy tailored to individual prescriptions. Other pharmacies also plan to continue making GLP-1 copycats, citing laws that allow compounding for patients needing specific formulations, people familiar with the industry told the Journal. 

The companies seek to take advantage of current law, which allows compounding for patients needing specific formulations. The FDA deadlines come on the heels of the official end of obesity drug shortages that had allowed compounding pharmacies to fill in supply gaps. 

Novo Nordisk Chief Executive David Ricks raised concerns about compounded drugs safety, arguing they lack regulatory oversight. 

In response, the drugmaker has sent cease-and-desist letters and ad campaigns warning against any compounded alternatives. A Novo Nordisk spokesperson told the Journal that the drugmaker has filed 105 lawsuits in federal courts alleging the marketing and sale of the knockoff versions. 

https://www.beckershospitalreview.com/glp-1s/will-fda-deadlines-reduce-compounded-versions-of-ozempic/