§ 461-15-5

§461-15.5 Distribution of dialysate drugs and devices. (a) The license, registration, and permit requirements of this chapter shall not apply to a manufacturer, wholesale distributor, manufacturer engaged in direct distribution to qualified persons, or third-party logistics provider, to the extent the manufacturer, wholesale distributor, manufacturer engaged in direct distribution to qualified persons, or third-party logistics provider is engaged in the distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease; provided that the following criteria shall be met: (1) The dialysate drugs or devices are approved by the United States Food and Drug Administration, as required by federal law; (2) The dialysate drugs or devices are lawfully held by a manufacturer or a manufacturer's agent that is properly licensed with the board as a manufacturer, wholesale distributor, or manufacturer engaged in direct distribution to qualified persons; (3) The dialysate drugs or devices are held and delivered in the original, sealed, and labeled packaging from the manufacturing facility; (4) The dialysate drugs or devices are delivered only by

ons; (3) The dialysate drugs or devices are held and delivered in the original, sealed, and labeled packaging from the manufacturing facility; (4) The dialysate drugs or devices are delivered only by the manufacturer or the manufacturer's agent and only upon receipt of an order by a physician, a physician assistant, or an advanced practice registered nurse with prescriptive authority; and (5) The manufacturer or the manufacturer's agent delivers the dialysate drugs or devices directly to: (A) A patient with end-stage renal disease, or the patient's designee, for the patient's self-administration of dialysis therapy; or (B) A health care provider or an institution for administration or delivery of dialysis therapy to a patient with end-stage renal disease. (b) For the purposes of this section: 'Manufacturer' has the same meaning as in section 328-112. 'Third-party logistics provider' means an entity that provides or coordinates warehousing or other logistics services on behalf of a manufacturer, wholesale distributor, or dispenser of a product. 'Wholesale distributor' has the same meaning as in section 328-112. [L 2023, c 101, §1]