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MI HB6477
Bill
Status
11/9/2022
Primary Sponsor
Steven Johnson
Click for details
AI Summary
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Establishes an international wholesale prescription drug importation program administered by the Department of Health and Human Services to import prescription drugs from foreign nations with recognized good manufacturing practice standards, effective by January 1, 2023.
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Creates a wholesale prescription drug importation list identifying eligible drugs that must meet FDA safety and effectiveness standards, cannot be controlled substances, biologicals, infused drugs, intravenously injected drugs, or inhaled surgical drugs, and must not violate federal patent laws.
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Requires importers and exporters to register with the department and submit detailed documentation including drug origin, lot numbers, manufacturing information, testing results for authenticity and degradation, and certification that drugs are FDA-approved and non-adulterated.
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Mandates independent laboratory testing of each drug batch for authenticity and degradation before importation, with department maintaining records for at least 7 years and authority to immediately suspend importation if violations are found.
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Prohibits distribution of imported drugs outside Michigan and requires the program to be approved or authorized under federal law before implementation.
Legislative Description
Health: pharmaceuticals; international wholesale prescription drug importation program; provide for. Creates new act.
Health: pharmaceuticals
Last Action
Bill Electronically Reproduced 11/10/2022
11/10/2022