Join us as we explore the dynamic world of compounding pharmacies tackling the challenging semaglutide shortages head-on.
Compounding pharmacies have stepped up to address the shortage of two semaglutide products, Ozempic and Wegovy. Consequently, they’re facing increased scrutiny from federal and state regulators, as well as Novo Nordisk, the manufacturer of these products. Novo Nordisk is actively monitoring and taking action against entities unlawfully selling compounded semaglutide.
The company has sent cease-and-desist letters to some 503A pharmacy compounders. This move is seen as the first step towards potential legal actions. The Alliance for Pharmacy Compounding has defended the rights of 503A pharmacies to compound active pharmaceutical ingredients (APIs) in brand-name medications for specific patients, as long as the brands are on the FDA’s “currently in shortage” list.
However, the distinction between legitimate 503A pharmacy compounders and shady operators has been blurred. These operators have rushed to fill the semaglutide gap without proper oversight of their compounding safety processes, source of APIs, or marketing techniques. This negligence could potentially cause serious patient harm.
Kristina Bryowsky, PharmD, MBA, Vice President of Pharmacy Services for SSM Health Care, Missouri Region, believes that 503A compounding pharmacies should be allowed to make a product for a patient if the brand-name drug is in shortage. However, she emphasizes the importance of ensuring that the ingredients used are similar to what is currently on the market.
The FDA agrees with this stance. In a letter, F. Gail Bormel, RPh, JD, Director of the FDA’s Center for Drug Evaluation and Research Office of Compounding Quality and Compliance, expressed concern about compounders using different salt forms of semaglutide.
One 503A compounding pharmacy that received a Novo Nordisk cease-and-desist warning last fall acted quickly in response. The pharmacy reviewed its marketing materials and website and removed any references to Ozempic or Wegovy. The representative of the pharmacy emphasized the importance of acting appropriately in the industry to avoid hurting the whole industry.
In conclusion, while the semaglutide that 503A pharmacies compound following a physician’s prescription is not a generic of Ozempic or Wegovy, it’s an API that may be mixed with other components to meet the therapeutic needs of a specific patient. Compounding pharmacies stand ready to fill the gap when shortages occur within the commercially approved market, as long as they’re doing it in a lawful way.