1. (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. (1) The dialysate drugs or devices are approved by the United States Food and Drug Administration, as required by federal law;
   2. (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. (3) The dialysate drugs or devices are held and delivered in the original, sealed, and labeled packaging from the manufacturing facility;
   4. (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. (5) The manufacturer or the manufacturer's agent delivers the dialysate drugs or devices directly to:

      1. (A) A patient with end-stage renal disease, or the patient's designee, for the patient's self-administration of dialysis therapy; or
      2. (B) A health care provider or an institution for administration or delivery of dialysis therapy to a patient with end-stage renal disease.

2. (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]