Updated September 2, 2025
As of late August 2025, Novo Nordisk, the manufacturer of FDA-approved semaglutide (including popular products such as Ozempic® and Wegovy®), is sending cease-and-desist letters to compounding pharmacies, outsourcing facilities, and telemedicine companies involved in the compounding or sale of compounded semaglutide products. These letters claim that compounded semaglutide is unapproved, unsafe, and violates FDA regulations, and demand that recipients immediately cease these activities.
What Does This Mean for You?
If you are involved in the compounding, distribution, or sale of compounded semaglutide, it is critical to understand the potential risks involved with these letters:
- Failure to Respond or Comply: If you do not respond or fail to cease your activities, Novo Nordisk has indicated that it will pursue legal action, which could involve costly litigation, regulatory investigations, and potential damages.
- Responding without Proper Guidance: Without understanding the legal implications of your response, you may inadvertently admit to unlawful activities or fail to address the complex regulatory environment surrounding compounded drugs. Responding prematurely without legal advice could escalate the situation and limit your options moving forward.
How Frier Levitt Can Help
Frier Levitt, a national healthcare and life sciences law firm, can work with your company, whether it be a pharmacy or other entity involved in compounding, to ensure compliance and mitigate risks. We can assist you by:
- Reviewing the Novo Nordisk Letter: We will evaluate the specifics of the cease-and-desist letter you received, assessing whether your activities align with FDA regulations and current industry standards.
- Determining a Strategic Response: We will help you craft a measured, informed response, ensuring that you address the concerns claimed in the letter appropriately and avoid escalating the situation.
- Providing Regulatory Guidance: As the grace period for compounded semaglutide products nears its end, we can provide guidance on how to comply with FDA regulations while continuing to compound semaglutide under the law. This includes determining whether any exemptions apply, advising on compliance with current good manufacturing practices (CGMP), and exploring alternatives if necessary. We can also provide assistance in working with your State Board of Pharmacy.
- Defending Against Legal Actions: If you are facing legal or regulatory action, we offer defense strategies to protect your business and ensure compliance with both state and federal laws.
The Time to Act is Now
If you have received a cease-and-desist letter or are concerned about the future of your compounded semaglutide business, we encourage you to contact us immediately. Our team of healthcare and life sciences attorneys can help you navigate the complexities of this situation, minimize risks, and protect your business interests.
For more information or to schedule a consultation, please contact us.
