Months after the FDA’s deadline for the manufacture and sale of compounded versions has passed, large-scale corporate compounders continue flooding the market with unapproved products. These are not your local pharmacists making a pediatric formulation or dye-free alternative. They are unregulated pharmaceutical companies flagrantly skirting rules and violating federal laws.
Left unaddressed, the mass production and misleading marketing of compounded GLP-1s will result in a public health disaster. FDA has already received dozens of adverse event reports tied to compounded GLP-1s — including hospitalizations, overdoses, and severe reactions — but the real number is likely far higher due to underreporting. When compounders mass produce and market without proper oversight, patient medical histories go unchecked, potential drug interactions are missed, and adverse events are underreported. This is not about access – it’s exploitation, pure and simple.
Our latest report lays out the problem in stark terms and offers a path forward grounded in existing law, sound policy, and patient safety imperatives. What we’re seeing today is a failure of enforcement, not a failure of policy.
The FDA doesn’t need new powers; it needs to enforce the ones it has. That means calling out bad actors, coordinating with states to shut down illegal operations, and ensuring compounded drugs are only used when there is a demonstrated medical need. Every day we delay, more patients are put at risk – and if we wait for a tragedy to act, the cost will be measured in lives.
