Legal Battles Over Compounded GLP-1 Weight Loss Drugs: What Consumers Need to Know

The landscape of weight loss medications is undergoing significant changes, particularly concerning compounded versions of GLP-1 receptor agonists like semaglutide (found in Ozempic and Wegovy) and tirzepatide (found in Mounjaro and Zepbound). Recent legal actions and FDA decisions are reshaping access to these treatments. 
Background: Compounding During Shortages
Compounding pharmacies have historically filled gaps during drug shortages by creating customized medications for patients. During the shortages of semaglutide and tirzepatide, which began around 2022, compounding pharmacies legally produced these medications to meet patient demand.  
FDA Declares Shortages Resolved
In late 2024, the FDA announced that the shortages of both semaglutide and tirzepatide had been resolved, citing increased production capacities from manufacturers. Consequently, the FDA mandated that compounding pharmacies cease production of these compounded versions. Deadlines were set: state-licensed pharmacies were to stop compounding semaglutide by April 22, 2025, and larger outsourcing facilities by May 22, 2025.   
Pharmaceutical Companies Take Legal Action
Eli Lilly and Novo Nordisk, the manufacturers of these GLP-1 drugs, have initiated lawsuits against several compounding pharmacies and telehealth companies. The allegations include unauthorized production and sale of compounded versions of their drugs, potentially compromising patient safety due to lack of FDA approval and oversight.  
Implications for Consumers
    •    Access and Affordability: Patients who relied on compounded versions due to cost or availability may face challenges accessing the brand-name drugs, which can be expensive and may not be covered by insurance. 
    
​Stay tuned.