HB 4979 Summary

• Establishes an international wholesale prescription drug importation program administered by the Department of Health and Human Services to begin by January 1, 2021, allowing importation of safe and effective drugs from foreign nations with mutual recognition or cooperation agreements with the United States.

• Creates a wholesale prescription drug importation list identifying eligible drugs for import, excluding controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, and certain parenteral drugs deemed a public health threat.

• Requires state importers and foreign exporters to register with the department and submit detailed documentation including drug source, quantity, lot numbers, pricing, and certification that imported drugs are FDA-approved, not adulterated or misbranded, and meet all labeling requirements.

• Mandates statistical sampling and testing of each batch for authenticity and degradation by department-approved laboratories meeting federal standards, with records maintained for at least 7 years.

• Authorizes the department to immediately suspend importation of specific drugs or by specific importers if violations occur and to revoke suspensions after investigation determines public safety.