HB 4978 Summary

• Establishes a prescription drug importation program allowing Michigan to import safe and effective drugs from Canada, subject to federal approval from the U.S. Secretary of Health and Human Services by January 1, 2021.

• Requires the Department of Health and Human Services to contract with a vendor to manage the program, develop a wholesale prescription drug importation list, and maintain eligible Canadian suppliers that comply with federal and state laws.

• Prohibits importation of controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, and certain parenteral drugs deemed a public health threat.

• Mandates safety and quality testing of imported drugs including statistical sampling for authenticity and degradation, with all testing conducted at FDA-compliant laboratories and records maintained for 7 years.

• Requires annual reporting to the governor and legislature on program operations, cost savings, participating suppliers and importers, prescriptions dispensed, and documentation that imported drugs remain within Michigan and do not pose increased health and safety risks.