This bill amends existing New Jersey law to establish an exemption from pharmacist licensing requirements for drug manufacturers and wholesale drug distributors involved in the distribution of dialysate drugs and devices for home dialysis in patients with end-stage renal disease. The bill specifies that these entities are not subject to the licensing requirements as long as they meet certain criteria, including that the drugs and devices must be approved by the FDA, held by a properly registered entity, delivered in original sealed packaging, and only delivered upon 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