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Hawaii Revised Statutes Division 2. Business § 461-15.5

Current as of January 01, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Hawaii Revised Statutes Division 2. Business § 461-15.5 - last updated January 01, 2025 | https://codes.findlaw.com/hi/division-2-business/hi-rev-st-sect-461-15-5/

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