This bill amends existing New Jersey pharmacy law to exempt drug manufacturers and wholesale drug distributors from the requirement of being licensed pharmacists when distributing dialysate drugs or devices for home dialysis to patients with end-stage renal disease. The bill specifies that these exemptions apply under certain conditions, including that the drugs and devices must be approved by the United States Food and Drug Administration, held by a properly registered entity, delivered in original sealed packaging, and only distributed upon receipt of a physician's order. Additionally, the delivery must be made directly to the patient or their designee, or to a healthcare provider or institution for administration.

Furthermore, the bill mandates that the manufacturer must contract with a registered consultant pharmacist to conduct weekly quality assurance assessments of the storage and distribution of the home dialysis drugs. This legislative change aims to streamline the distribution process for essential dialysis-related products while ensuring patient safety through regulatory oversight. The act will take effect on the first day of the third month following its enactment.

Statutes affected:
Introduced: 45:14-49