CU Anschutz researchers found the compounded GLP-1 market remains robust after FDA shortages ended, with some products supplied by pharmacies lacking sterile compounding licenses or with recent disciplinary histories
Despite the end of federal shortages of popular GLP-1 weight-loss medications, the market for compounded alternatives remains strong - and some patients may unknowingly be receiving products from pharmacies with concerning regulatory histories, according to new research from the University of Colorado Anschutz.
Published today in JAMA Health Forum, the study found that many weight-loss clinics and medical spas continue to sell compounded versions of GLP-1 medications such as semaglutide and tirzepatide. Researchers also identified suppliers that lacked licenses required for sterile compounding or had recently been subject to disciplinary actions related to sterile compounding practices.
"Our findings suggest this market didn't shrink after the shortages ended as many expected," said lead author Michael J. DiStefano, PhD, MBE, assistant professor at the University of Colorado Anschutz Skaggs School of Pharmacy and Pharmaceutical Sciences. "Instead, it has remained remarkably robust, raising important questions about how these products are regulated and how patients can know whether they're receiving medications that meet appropriate quality standards."
Compounded GLP-1 drugs expanded rapidly during nationwide shortages of Wegovy and Zepbound, when federal regulations temporarily allowed pharmacies to compound copies of medications in short supply. Researchers wanted to know what happened after those shortages ended and the FDA resumed enforcement against routine copies of commercially available products. DiStefano and colleagues examined brick-and-mortar weight-loss clinics and medical spas, an area that has received less scrutiny than online telehealth despite serving many patients.
Using a "secret shopper" approach, researchers contacted businesses in Oklahoma and West Virginia to ask what products were available, how patients were monitored and where the medications were sourced. The team identified 75 clinics and medical spas offering compounded GLP-1 medications. Instead of seeing the market disappear, the researchers found evidence that many compounded products now include added ingredients, such as vitamin B12, which may be presented as individualized formulations.
"One concern is whether we're seeing clinically meaningful personalization or changes that primarily allow compounded products to remain on the market," DiStefano said. "For many of these added ingredients, we simply don't have good evidence showing they improve safety or effectiveness."
Additionally, among the 23 compounding pharmacies supplying these businesses, four lacked licenses for sterile compounding, while several had recent disciplinary actions or FDA warning letters related to sterile compounding practices.
DiStefano emphasized that compounded GLP-1 medications have helped expand access for patients who cannot afford brand-name drugs or whose insurance does not cover obesity treatment.
However, he said patients should not have to choose between affordability and quality.
"This market has grown so large and diffuse that it's difficult for regulators to oversee every pharmacy supplying these medications," he said. "Our findings suggest there's a need for regulatory innovation that preserves access while giving patients greater confidence that the products they're receiving are safe and appropriately manufactured."
The researchers hope the findings encourage clinicians and patients to ask more questions about where compounded medications originate and whether the pharmacies producing them meet appropriate standards for sterile compounding.
