(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 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.”
