CS for CS for SB 1528 - Prescription Drug Importation Programs

• Establishes the Canadian Prescription Drug Importation Program under the Agency for Health Care Administration to import safe and effective prescription drugs from Canada, with a vendor contracted to manage the program and develop lists of drugs with highest cost-saving potential.

• Requires the agency to request federal approval by July 1, 2020, and begin operations within 6 months of approval; eligible importers include pharmacists and wholesalers employed by county health departments, Medicaid pharmacies, Department of Corrections, and other state facilities.

• Creates the International Prescription Drug Importation Program allowing wholesale distributors, pharmacies, and pharmacists to import prescription drugs from foreign countries with U.S. mutual recognition agreements; requires importers and exporters to register with the Department of Business and Professional Regulation.

• Establishes permitting requirements for international export pharmacies and international prescription drug wholesale distributors with surety bonds of at least $25,000 (or 10% of annual sales/$1 million for manufacturers and wholesalers) and comprehensive drug supply chain documentation and testing requirements.

• Excludes controlled substances, biological products, infused drugs, intravenously injected drugs, and certain surgical anesthetics from importation; requires immediate suspension of non-compliant drugs or importers and annual reporting to the Governor and Legislature.