The drugmaker argues that the medications are too complex to be safely compounded, citing risks such as impurities, incorrect dosages and instances in which compounded versions contained no active ingredient.
The American Diabetes Association urged clinicians and patients to avoid compounded GLP-1 versions of Ozempic, according to a Dec. 2 guidance statement published in Diabetes Care. The association stressed that compounded drugs are not FDA approved and may carry safety risks.
The ADA also recommended that if Ozempic and Wegovy are unavailable, healthcare providers should switch to other FDA-approved alternatives for managing diabetes and weight loss.
Novo Nordisk’s move is a part of a broader effort to clamp down on the production of compounded semaglutide, the active ingredient in Wegovy and Ozempic, which has been in an intermittent shortage for the past two years.
The FDA is still reviewing Novo Nordisk’s petition and has yet to make a final decision, CNBC reported Oct. 23. Meanwhile, compounding pharmacies, which have stepped in to provide alternatives during the ongoing shortage, argue that compounded versions of the drugs have helped address patient needs especially given the high cost of the branded medications.
In response, the Alliance for Compounded Pharmacy voiced strong opposition to Novo Nordisk’s petition, defending the safety and quality of compounded semaglutide and questioning the company’s motivations, according to a Dec. 3 news release shared with Becker’s.
The APC, which represents more than 5,000 compounding pharmacists and healthcare professionals, argued that the availability of compounded medications is critical to meeting patient demand, especially as shortages of branded GLP-1 drugs continue.
