FL S1452

Establishes Canadian Prescription Drug Importation Program within Agency for Health Care Administration to import safe and effective prescription drugs from Canada for cost savings, requiring federal approval by July 1, 2020 and beginning operations within 6 months of approval.

Creates International Prescription Drug Importation Program within Department of Business and Professional Regulation for importing prescription drugs from foreign nations with U.S. mutual recognition agreements, requiring importers and exporters to register and submit detailed supply chain documentation.

Prohibits importation of controlled substances, biological products, infused drugs, intravenously injected drugs, and drugs inhaled during surgery; requires imported drugs to meet FDA standards and not violate U.S. patent laws.

Establishes international export pharmacy permits for foreign pharmacies and international prescription drug wholesale distributor permits for foreign distributors participating in the importation programs, with inspection and enforcement authority granted to the state.

Implementation is contingent upon Department of Business and Professional Regulation and Department of Health negotiating a federal arrangement or obtaining federal guidance for a pilot importation program demonstrating safety standards and enforcement authority.