What is the legal framework governing the export of drugs?

In Washington, the legal framework governing the export of drugs is predominantly provided in the Washington Administrative Code (WAC) Chapter 246-335-022. This section outlines the regulations related to manufacturers and wholesalers of pharmaceuticals and outlines the requirements needed to export drugs. Before exporting drugs, manufacturers and wholesalers must obtain a valid Export Certificate from the Washington State Department of Health (DOH). The DOH will review all relevant information on the export request and if they find that the drugs meet their standards, the request is approved. To ensure accuracy and safety, the DOH only approves export requests for drugs that have been approved by the FDA, the United States Drug Enforcement Administration, and the World Health Organization. The WAC 246-335-022 also outlines the standards for the labeling and packaging of any drugs that are exported from Washington. All labeling must be legible and prominently display the drug name, expiration date, lot/batch numbers, and the name and address of the manufacturer or wholesaler of the drug. In addition to these requirements, exporters must also take steps to ensure that all drugs are shipped safely and securely. The exporter must properly identify and package the drugs in a manner that protects the integrity of the drugs, as well as keep detailed records of the ship date, destination, and type of drugs shipped. The regulations outlined in WAC 246-335-022 are in place to ensure the safe and legal export of drugs in Washington. These regulations are closely monitored by the DOH and must be followed by all manufacturers and wholesalers of pharmaceuticals. Compliance with these regulations can help protect both public health and the public purse.

What is the legal framework governing the export of drugs?

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