FDA Warning Letters to
Compounding Pharmacies and Suppliers

The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment. Most sellers do what FDA requests. This page indexes warning letters sent to compounding pharmacies and suppliers who have (a) prepared or distributed prescription drugs or other drug products that lack FDA approval, (b) made products available without individual prescriptions required by law, (c) had unsanitary conditions, and/or violated other good manufacturing practices (GMPs).

Other FDA Actions

This page was revised on March 13, 2019.

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