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A 5921

Creates the jockey health insurance reserve fund

2025 Regular Session Introduced by Carrie Woerner

Creates a narrow exemption allowing FDA-approved dialysate drugs/devices to be distributed for home dialysis by manufacturers/distributors, with strict oversight.

SIGNED CHAP.493
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Bill Summary · A 5921

Summary — A5921 (Introduced Version)

Note: The title in the provided metadata ("Creates the jockey health insurance reserve fund") does not match the bill text. This summary is based on the bill text and statement provided, which amend pharmacy law to address distribution of dialysate drugs and home‑dialysis devices.

Main purpose

To exempt drug manufacturers and wholesale drug distributors — to the limited extent described — from New Jersey’s pharmacist‑licensing requirement when they distribute dialysate drugs or devices necessary for home dialysis to patients with end‑stage renal disease (ESRD), while establishing conditions and pharmacist oversight to protect safety and quality.

Key provisions

  • Amends Section 10 of P.L.2003, c.280 (C.45:14‑49) to create a limited exemption from the State’s pharmacy licensing requirements for manufacturers/wholesale distributors engaged in distribution of dialysate drugs/devices for home dialysis.
  • The exemption applies only if all the following criteria are met:
    1. The dialysate drugs/devices are approved by the U.S. Food and Drug Administration.
    2. The products are lawfully held by a properly registered manufacturer or manufacturer’s agent (registered as a manufacturer or wholesale drug distributor).
    3. Products are held and delivered in original, sealed, labeled packaging straight from the manufacturing facility.
    4. Delivery is performed only by the manufacturer or the manufacturer’s agent and only upon receipt of a physician’s order.
    5. Delivery is made directly to a patient with ESRD (or the patient’s designee) for self‑administration, or to a health care provider or institution for administration/delivery to a patient.
    6. The manufacturer must contract with a board‑registered consultant pharmacist who provides weekly quality assurance assessments of home‑dialysis drug storage and distribution.
  • All other provisions of P.L.2003, c.280 remain in force; the exemption is narrowly tailored to the specified home‑dialysis distribution activities.
  • Effective date: the act takes effect on the first day of the third month after enactment (e.g., with enactment on Nov. 12, 2025 → Feb. 1, 2026).

Who is affected

  • Directly: drug manufacturers and wholesale distributors that supply dialysate drugs/devices for home dialysis; consultant pharmacists contracted to provide oversight.
  • Indirectly: patients with ESRD receiving home dialysis, physicians issuing orders, healthcare providers/institutions administering dialysis, and pharmacy/license regulators.

Expected impact and considerations

  • Intended to facilitate direct manufacturer/distributor delivery of home‑dialysis supplies to patients (potentially improving access and supply reliability).
  • Maintains patient safety guardrails: FDA approval, sealed packaging, physician orders, delivery controls, and weekly pharmacist QA assessments.
  • Regulatory oversight remains important (registration requirements and consultant pharmacist duties). The weekly assessment requirement is a notable, specific oversight obligation for manufacturers.

Legislative status and history (selected)

  • Introduced in Assembly: July 24, 2025 (sponsor: Asm. Carrie Woerner).
  • Passed both houses and delivered to Governor: Nov. 3, 2025.
  • Signed into law: Nov. 12, 2025 (Chapter 493).
  • Related/companion bills: S4601, S2618.

Compiled from official sources — confirm details with the bill’s official record.

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