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Bill > S4601
NJ S4601
NJ S4601Establishes pharmacist licensing exemption for certain dialysis-related drugs and devices.
summary
Introduced
06/12/2025
06/12/2025
In Committee
06/12/2025
06/12/2025
Crossed Over
Passed
Dead
01/12/2026
01/12/2026
Introduced Session
2024-2025 Regular Session
Bill Summary
This bill exempts drug manufacturers and wholesale drug distributors from the requirement of being a licensed pharmacist when they are engaged in the distribution of dialysate drugs or devices to patients with end-stage renal disease under certain circumstances. Under the bill, drug manufacturers and wholesale drug distributors would not be subject to pharmacist licensing requirements to the extent that they are engaged in the distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease. For the purposes of the bill, the following would be required of the drugs and devices: (1) approval by the United States Food and Drug Administration; (2) be held by an entity that is properly registered; (3) be held and delivered in original, sealed labeled packaging; (4) delivery only by the manufacturer or the manufacturer's agent and only upon receipt of a physician's order; (5) delivery is made to a patient, the patient's designee, a health care provider, or an institution for administration or delivery of the dialysis therapy to the patient; and (6) periodic oversight of manufacturers and distributors by a licensed pharmacist.
AI Summary
This bill establishes an exemption from pharmacist licensing requirements for drug manufacturers and wholesale drug distributors when they distribute dialysate drugs or devices for home dialysis patients with end-stage renal disease (ESRD). Specifically, the exemption applies when certain strict conditions are met, including FDA approval of the drugs or devices, proper registration of the manufacturer, delivery in original sealed packaging, distribution only upon a physician's order, direct delivery to the patient, patient's designee, healthcare provider, or institution, and weekly quality assurance assessments by a consultant pharmacist. The bill amends existing pharmacy licensing laws to create this targeted exemption, recognizing the unique needs of home dialysis patients who require specialized medical supplies. By allowing manufacturers and distributors to directly deliver these essential medical items without full pharmacist licensing, the bill aims to streamline the process of obtaining critical dialysis supplies for patients managing end-stage renal disease at home. The new provisions will take effect on the first day of the third month following the bill's enactment.
Committee Categories
Business and Industry
Sponsors (3)
Last Action
Introduced in the Senate, Referred to Senate Commerce Committee (on 06/12/2025)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.njleg.state.nj.us/bill-search/2024/S4601 |
| BillText | https://pub.njleg.gov/Bills/2024/S5000/4601_I1.HTM |
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