ASSEMBLY REGULATED PROFESSIONS COMMITTEE

STATEMENT TO

ASSEMBLY, No. 2001

STATE OF NEW JERSEY

DATED: FEBRUARY 12, 2026

      The Assembly Regulated Professions Committee reports favorably Assembly Bill No. 2001.

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.

      This bill was prefiled for introduction in the 2026-2027 session pending technical review.  As reported, the bill includes the changes required by technical review, which has been performed.