Distribution of dialysate drugs and devices

HRS §461-15.5, under Chapter 461.

HRS §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:

(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]