On The Pen can confirm that Novo Nordisk is ramping up its legal fight against compounding pharmacies and businesses selling unauthorized versions of semaglutide. In a new round of cease-and-desist letters, the pharmaceutical giant demands that multiple telehealth companies (who prefer anonymity) that are allegedly involved in distributing compounded semaglutide, immediately stop selling these products or face legal consequences.
This move follows the FDA’s recent decision on February 21, 2025, declaring that the shortages of Ozempic and Wegovy are officially over. That ruling, which is now being challenged in court, has major implications for compounding, effectively making it illegal to mass-produce, Here’s what you need to know about Novo Nordisk’s latest crackdown.
The Case Against Compounded Semaglutide
In the letters, Novo Nordisk argues that compounded versions of semaglutide are unapproved, unsafe, and legally restricted now that the shortage has been resolved. The company outlines three main concerns:
Patient Safety Risks: The semaglutide in Ozempic and Wegovy is produced using recombinant DNA technology in yeast, a process Novo says is difficult to replicate. Many compounded versions use synthetic semaglutide, which may have different impurity profiles and stability issues. The FDA has also issued multiple warnings about contaminated and mislabeled compounded versions leading to dosing errors and adverse effects.
New FDA Restrictions on Compounding: With the shortage over, the FDA no longer allows outsourcing facilities to compound semaglutide. Compounding pharmacies can still make small amounts, but they cannot regularly produce drugs that are essentially copies of Ozempic or Wegovy. Novo Nordisk points out that this also applies to telehealth companies, weight loss clinics, and medical spas that partner with compounders—they, too, are now prohibited from selling these products.
Legal Action on the Horizon: Novo Nordisk has already filed over 100 lawsuits against companies selling unauthorized semaglutide, with many courts issuing permanent bans. The company is giving recipients of the letters until March 7, 2025, to comply—or risk being added to the growing list of legal battles.
What This Means for Patients
For those who have relied on compounded semaglutide due to cost or access issues, this development raises serious concerns. If Novo Nordisk’s legal strategy succeeds, compounded semaglutide will likely become more challenging to obtain, relying on medically necessary custom dosing and formulations to prescribe.
While some argue that compounding plays a role in increasing accessibility, Novo Nordisk maintains that its FDA-approved products are the only ones with proven safety and efficacy. With the FDA enforcement looming, patients may soon have no choice but to seek semaglutide through traditional pharmacy channels, which means grappling with insurance restrictions, prior authorizations, and potentially high out-of-pocket costs.
The Bottom Line
Novo Nordisk has made it clear that now that the FDA has ruled there is no shortage, the legal hammer is dropping. If you’ve been using compounded semaglutide, this is a critical moment to stay informed. The legal landscape is shifting fast, and the future of compounded GLP-1 medications is on shaky ground.
UPDATE 03.03.2025
On The Pen has been given clearance to share this redacted version of the letters being sent out by Novo Nordisk.
Breaking also this morning, On The Pen can also now confirm that, in a departure from Lilly's approach, Novo Nordisk has also sent these letters to small compound pharmacies.