{"data":{"id":"us-hi/haw.-rev.-stat.-461-15.5","jurisdiction":"us-hi","citation":"Haw. Rev. Stat. § 461-15.5","heading":"[ §461-15.","body":"[ §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:\n\n(1) The dialysate drugs or devices are approved by the United States Food and Drug Administration, as required by federal law;\n\n(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;\n\n(3) The dialysate drugs or devices are held and delivered in the original, sealed, and labeled packaging from the manufacturing facility;\n\n(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\n\n(5) The manufacturer or the manufacturer's agent delivers the dialysate drugs or devices directly to:\n\n(A) A patient with end-stage renal disease, or the patient's designee, for the patient's self-administration of dialysis therapy; or\n\n(B) A health care provider or an institution for administration or delivery of dialysis therapy to a patient with end-stage renal disease.\n\n(b) For the purposes of this section:\n\n\"Manufacturer\" has the same meaning as in section 328-112.\n\n\"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.\n\n\"Wholesale distributor\" has the same meaning as in section 328-112.","path":["HI Code","Division 2","Title 25","Chapter 461"],"source_url":"http://www.capitol.hawaii.gov/hrscurrent/Vol10_Ch0436-0474/HRS0461/HRS_0461-0015_0005.htm","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:11Z","sha256":"4286ba80a67b75b5877bf5f481b1c4e16bc9727686a93b62bc11a5b8ec2509e9","source_id":"us-hi","stale":false,"prev":"us-hi/haw.-rev.-stat.-461-15","next":"us-hi/haw.-rev.-stat.-461-16"},"notice":"GroundRules: Original legal text. Not legal advice."}