Recent enforcement actions by the US Food and Drug Administration (FDA) and the US Department of Justice (DOJ) highlight ongoing government scrutiny regarding the sources of prescription drugs and medical devices dispensed by healthcare providers. Importantly, this scrutiny is not limited to distributors: federal regulators have pursued criminal and civil actions against physicians and physician practices that receive drugs and devices from unauthorized sources. Accordingly, healthcare providers should take proactive steps to avoid obtaining drugs and devices from unauthorized sources, particularly foreign entities (e.g., online retail pharmacies based in foreign countries).
Regulation of the Supply Chain of Drugs and Devices from Foreign Sources
The FDA regulates the supply chain of prescription drugs through the Drug Supply Chain Security Act (DSCSA), which requires dispensers, (including physicians), to purchase drugs from “authorized trading partners,” such as manufacturers registered with the FDA, wholesale distributors licensed by the states where they conduct business, or other trading partners registered with or licensed by the appropriate state or federal entity. While the DSCSA does not apply to devices, (including viscosupplements, which are classified as devices), other regulations require foreign device manufacturers and importers/exporters to register with the FDA before distributing a device in the United States.
Learn more about the potential liability associated with unapproved drugs or devices by clicking below.