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Bill > A5921
NJ A5921
NJ A5921Establishes pharmacist licensing exemption for certain dialysis-related drugs and devices.
summary
Introduced
07/24/2025
07/24/2025
In Committee
07/24/2025
07/24/2025
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 a pharmacist licensing exemption 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 bill allows these manufacturers and distributors to be exempt from standard pharmacist licensing requirements if they meet six key criteria: (1) the drugs or devices are FDA-approved, (2) they are held by a properly registered manufacturer or agent, (3) they are delivered in original, sealed packaging, (4) they are delivered only by the manufacturer or agent with a physician's order, (5) they are delivered directly to the patient, patient's designee, healthcare provider, or institution, and (6) a consultant pharmacist provides weekly quality assurance assessments of drug storage and distribution. The bill amends existing pharmacy licensing laws to create this specific exemption, recognizing the unique needs of home dialysis patients who require specialized medical supplies. The exemption is designed to streamline the distribution of necessary medical devices and drugs while maintaining appropriate oversight through the requirement of a consultant pharmacist's periodic review. The law will take effect on the first day of the third month following its enactment.
Committee Categories
Business and Industry
Sponsors (1)
Last Action
Introduced, Referred to Assembly Regulated Professions Committee (on 07/24/2025)
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/A5921 |
| BillText | https://pub.njleg.gov/Bills/2024/A6000/5921_I1.HTM |
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