Novo’s cease-and-desist letters — what to know

Novo Nordisk is sending out cease-and-desist letters to compounders since the FDA marked the semaglutide injection shortage as resolved. No surprise, but the letters don’t mention the FDA’s 60-day “off-ramp” for 503As (90 days for 503Bs). 

It’s a typical scare tactic from the company, but it’s definitely not something to ignore. If your pharmacy receives one of these letters from Novo, Eli Lilly, or another GLP-1 manufacturer, you’ll want to handle the situation carefully. While these letters can be intimidating, they are not lawsuits but rather preliminary legal notices. How you respond can have significant implications for your pharmacy.

Click here for a detailed guide from the pharmacy law firm Boesen and Snow (PDF) outlining best practices for handling such letters. We strongly recommend that you consult with your own attorney before taking any action, as legal responses should be tailored to your specific circumstances. Avoid making public statements, do not ignore the letter, and seek professional legal guidance to determine the best course of action.