Around 1.5 million Americans are taking compounded GLP-1 drugs despite the end of US shortages, with the FDA linking these products to more than 1,150 adverse events, 100 hospital admissions and at least 10 deaths.
What are compounded medicines?
Compounded medicines are pharmacy-prepared versions of drugs made for individual patients, typically when a licensed product cannot meet a specific clinical need. During US GLP-1 shortages a few years ago, pharmacies were also permitted to produce compounded semaglutide and tirzepatide, but the FDA says that exemption ended once supplies recovered in early 2025.
A new briefing from the Californian-based think tank Pacific Research Institute (PRI) warns that continued large-scale sales are not only putting patients at risk but could wipe out between $9.3bn and $11.8bn in future R&D investment – enough to cost the world four to five new medicines.
FDA steps up enforcement
The FDA has since sent warning letters to 30 telehealth firms and restricted the use of GLP-1 active pharmaceutical ingredients in unapproved compounds. However, some companies continue to argue their products remain lawful because they offer customised doses or formulations.
Wayne Winegarden, Director, PRI Center for Medical Economics and Innovation, said: “GLP-1s are among the most promising medical breakthroughs in decades… But allowing unauthorised manufacturers to mass market GLP-1 knockoffs outside FDA safeguards creates significant patient safety risks and undermines trust in the healthcare system.”
Safety and innovation concerns
The report cites concerns including poor storage, dosing errors, questionable ingredient sourcing and counterfeit products. A review of 2,465 shipments found 239 came from unregistered foreign entities, with 60 originating in China or Hong Kong.
In February 2026, the Department of Health and Human Services referred a well-known US telehealth platform Hims & Hers to the Department of Justice over alleged breaches of federal drug law.
Shabbir Safdar, Executive Director, Partnership for Safe Medicines, said: “Compounders operate on the outskirts of drug safety regulations and don’t face the same stringent requirements.”
The briefing calls for compounders to meet the same FDA standards as drug manufacturers and for stricter enforcement of patent rights during market exclusivity periods.
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