This bill establishes 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 amends Section 10 of P.L.2003, c.280, clarifying that the provisions of this act do not apply to these entities under specific conditions. These conditions include that the dialysate drugs or devices must be FDA-approved, 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.

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 ensures that while the licensing requirement is waived, there is still oversight to maintain safety and quality in the distribution process. The act will take effect on the first day of the third month following its enactment.

Statutes affected:
Introduced: 45:14-49