Compounded GLP-1s remain common, raising oversight concerns

Clinical takeaway: When patients use or request compounded GLP-1 medications, ask which pharmacy supplies the product and whether it meets appropriate sterile compounding standards. Compounded products may remain appropriate in select circumstances, but clinicians should discuss regulatory oversight and the limited evidence supporting added ingredients.

Compounded semaglutide and tirzepatide became widely used during nationwide shortages of branded GLP-1 medications. Although those shortages have ended, a new study suggests compounded products remain readily available, with some being supplied by pharmacies with recent regulatory or licensing concerns.

Researchers used a secret shopper approach to contact 75 weight-loss clinics and medical spas in Oklahoma and West Virginia that offered compounded GLP-1 receptor agonists. Nearly 60% of businesses reported selling compounded products that included added ingredients, most commonly B vitamins, although evidence supporting these additives is limited. Oral compounded formulations were also available at about 9% of businesses.

The investigators identified 23 compounding pharmacies supplying these businesses. Four lacked licenses to perform sterile compounding. One pharmacy had received multiple FDA warning letters since 2023, and three had recent state disciplinary actions related to sterile compounding practices. However, the study did not assess the safety, quality, or effectiveness of the compounded medications themselves.

The findings highlight an ongoing challenge for clinicians caring for patients who obtain compounded GLP-1 medications because of cost or insurance barriers. Current guidance recommends verifying the source of compounded products and ensuring appropriate patient monitoring. The study also found that while most clinics required at least monthly follow-up visits, a small minority reported no routine follow-up.

"This market has grown so large and diffuse that it's difficult for regulators to oversee every pharmacy supplying these medications," said lead author Michael J. DiStefano, PhD, MBE, assistant professor at the University of Colorado Anschutz Skaggs School of Pharmacy and Pharmaceutical Sciences. "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."

Source: DiStefano MJ, et al. (2026 Jul 17) JAMA Health Forum. Postshortage compounded GLP-1 RA market in 2 states with potentially high demand