§ 17-92-116 — Exemption for home peritoneal kidney dialysis

(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.

Legislative History

Added by Act 2017, No. 722,§ 1, eff. 8/1/2017.