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HI SB473
Bill
Status
6/22/2023
Primary Sponsor
Maile Shimabukuro
Click for details
AI Summary
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Exempts drug manufacturers, wholesale prescription drug distributors, and third-party logistics providers from pharmacy license, registration, and permit requirements when distributing dialysate drugs and devices for home dialysis treatment of end-stage renal disease patients.
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Requires dialysate drugs and devices to be FDA-approved, lawfully held by registered manufacturers or their agents, and maintained in original sealed packaging from the manufacturing facility.
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Mandates that dialysate drugs and devices be delivered only by the manufacturer or manufacturer's agent upon receipt of a physician's order.
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Allows delivery directly to patients with end-stage renal disease (or their designees) for self-administration or to healthcare providers and institutions for patient administration of dialysis therapy.
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Defines "manufacturer," "wholesale distributor," and "third-party logistics provider" for purposes of the exemption; effective December 31, 2050.
Legislative Description
Relating To The Practice Of Pharmacy.
Exemption
Last Action
Act 101, 06/22/2023 (Gov. Msg. No. 1202).
6/22/2023