What is the legal framework governing the export of drugs?

In Tennessee, the Pharmacy Practice Act of 2018 outlines the legal framework governing the export of drugs. This act ensures that all drugs exported from the state comply with the US Drug and Food Administration (FDA) standards. To export prescription medication, an export license from the Tennessee Board of Pharmacy is required. The license is issued to a manufacturer, wholesaler, or distributor, and can only be used for one shipment. The Drugs and Cosmetics Act of 1940 (DC Act) is also applicable to the export of drugs from Tennessee. This act prohibits the export of drugs that are not registered with the FDA, or any other authority. Additionally, the DC Act requires that the export and import of commercial quantities of drugs be authorized by the state government. In addition to these laws, the Export Administration Regulations also regulate the export of drugs internationally. These regulations stipulate that all drugs exported must be registered with the FDA and follow the relevant laws and regulations of the destination country. Drugs must also be accompanied by a Certificate of Analysis detailing any potential health or safety risks. Overall, the legal framework governing the export of drugs in Tennessee is multifaceted and designed to protect public health. It is important for all companies and individuals exporting drugs in Tennessee to follow these laws in order to avoid potential legal consequences.

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