Novo Nordisk, the maker of Ozempic and Wegovy, announced on Tuesday, June 20, that it was taking action against certain medical spas, medical weight loss clinics and pharmacies that, they allege, have been unfairly competing with and falsely marketing and advertising their drugs. Specifically, they have filed lawsuits in federal court against businesses located in New York, Florida, Texas, and Tennessee. At this point, it appears only four businesses are named but additional suits may be forthcoming.
The information and resources on this page can help you make decisions on how you use and market semaglutides and tirzepatides in your medical aesthetic practice.
How much longer will the popular weight loss medications be in shortage, and what happens in your med spa when they can no longer be compounded? This week, AmSpa founder and CEO, Alex R. Thiersch, JD, is joined by Sam Pondrom, JD, associate at national healthcare law firm ByrdAdatto. They talk about the recent availability status updates for tirzepatide and semaglutide, and what changes medical spas can anticipate when the brand-name medications become fully available.
AmSpa CEO, Alex R. Thiersch, JD, speaks with Dr. Brittny Williams Howell, board-certified vascular surgeon and CEO of Morph Med Spa in Ridgefield, Connecticut. They discuss medical weight loss programs, the effectiveness of weight loss solutions and the financial implications of working with a compound pharmacy vs. health insurance.
AmSpa CEO, Alex R. Thiersch, JD, speaks with Patrick O’Brien, JD, of AmSpa and ByrdAdatto, to discuss the legal concerns with compounded semaglutide and its name-brand drugs. They talk about the basic legal implications of Ozempic and recent lawsuits, compounding pharmacy issues and general guidelines for navigating this area of the law.
AmSpa CEO, Alex R. Thiersch, JD, speaks with Taylor Siemens, NP-C, founder of Aesthetic Care NP and clinical director of Vitalyc Medspa. They discuss medical weight loss programs and protocols for offering semaglutide in your aesthetic practice.
According to the FDA, in some circumstances, when a drug appears on the FDA's drug shortages list, drugs may be compounded and distributed with fewer restrictions. While semaglutide and tirzepatide appeared on the FDA's Drug Shortages list, compounding pharmacies were able to prepare a compounded version of those drugs if they met certain requirements in the Federal Food, Drug and Cosmetic Act. The resolution of GLP-1 medication shortages has ended the temporary allowance for pharmacies and outsourcing facilities to compound these drugs under the shortage exception.
As of August 14, 2024, the shortage of both of Eli Lilly's brand name tirzepatide medications Mounjaro and Zepbound was listed as "Resolved." Smaller compounding pharmacies had until February 18, 2025 or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA in the Northern District of Texas, whichever was longer. The court denied the preliminary injunction motion on March 5, 2025, marking an end to compounding tirzepatide. Larger compounding pharmacies had until March 19, 2025, to stop compounding, dispensing or distributing tirzepatide.
On February 21, 2025, the shortage of semaglutide, the active ingredient in Novo Nordisk's brand name medications Ozempic and Wegovy, was listed as "Resolved." Smaller compounding pharmacies had until April 22, 2025, or until the district court ruled on the plaintiffs’ motion for a preliminary injunction in OFA v. FDA to stop making semaglutide products, whichever was later. The court denied the preliminary injunction motion on April 24, 2025, ending semaglutide compounding for smaller compounding pharmacies. Larger compounding pharmacies have until May 22, 2025, to stop producing and dispensing semaglutide.
Compounding these drugs in the same formulation is no longer permitted under FDA guidelines, so practices must update their advertising, websites and other promotional materials to reflect the current situation and ensure compliance.
No. Even if a drug is compounded in the same formulation as a trademarked product, you cannot use that brand name if you didn't acquire it from the original company.
No. Even if a drug is compounded in the same formulation as the FDA-approved product, according to the FDA, "Compounded drugs are not FDA-approved."
It depends. In many cases, compounded drugs are able to provide necessary treatment to patients during times of shortage. Regarding semaglutides specifically, the FDA recently released a warning regarding adverse reports from patients after using semaglutides that were not compounded correctly.
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