ARSD 20:51:05:23. Distribution of dialysate or dialysis devices by the manufacturer or manufacturer's agent to a patient - Exempt from pharmacy licensure

A manufacturer of dialysate and dialysis devices or an agent of a manufacturer may ship dialysate and dialysis devices directly to a patient in this state, to an agent of the patient, or to a health care practitioner or institution, for administration or delivery of dialysis therapy, to a patient with chronic kidney failure, without being licensed as a pharmacy in this state if the following criteria have been met: (1) The manufacturer or manufacturer's agent shipping the dialysate is licensed as a wholesaler or other drug distributor; (2) The dialysate is stored and delivered in the original, sealed, and labeled package from the manufacturing facility; and (3) The dialysate or dialysis devices are delivered only upon receipt of a prescription order issued by a licensed practitioner and only if an order from a licensed pharmacy is transmitted to the manufacturer or the manufacturer's agent. Records for all sales and distribution of dialysate must be retained and readily available for inspection for a period of two years from the date of the transaction.