2017 Arkansas Code
Title 17 - Professions, Occupations, and Businesses
Subtitle 3 - Medical Professions
Chapter 92 - Pharmacists and Pharmacies
Subchapter 1 - General Provisions
§ 17-92-116. Exemption for home peritoneal kidney dialysis

Universal Citation: AR Code § 17-92-116 (2017)
  • (a) The provisions of §§ 17-92-101, 17-92-103, 17-92-105, 17-92-205, 17-92-206, 17-92-303, 17-92-401, 17-92-402, 17-92-404, 17-92-405, 17-92-409, 17-92-410, 17-92-411, and 17-92-902 do not apply to the sale or distribution of dialysate or devices necessary to perform home peritoneal kidney dialysis to patients with end-stage renal disease if:
    • (1) The dialysate composed of dextrose or icodextrin or devices are:
      • (A) Approved or cleared by the United States Food and Drug Administration as required by federal law;
      • (B) Lawfully held by a manufacturer or a third-party logistics provider of the manufacturer that is properly registered with the Arkansas State Board of Pharmacy as a wholesale distributor or medical device provider;
      • (C) Held and delivered in original, sealed packaging from the manufacturing facility; and
      • (D) Delivered only by the manufacturer or a third-party logistics provider of the manufacturer and only upon receipt of a physician's order by a licensed pharmacy and the transmittal of an order from a licensed pharmacy to the manufacturer or a third-party logistics provider of the manufacturer; and
    • (2) The manufacturer or a third-party logistics provider of the manufacturer delivers the dialysate or devices directly to:
      • (A) A patient with end-stage renal disease or a designee for the self-administration of the dialysis therapy; or
      • (B) A healthcare provider or institution for administration or delivery of the dialysis therapy to a patient with end-stage renal disease.
  • (b)
    • (1) The board shall retain oversight of all other drugs for home peritoneal kidney dialysis with the exception of dialysate as described in subdivision (a)(1) of this section.
    • (2) All records of sales and distribution of dialysate to patients under this section shall be retained according to state law and rule of the board.
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