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. (1) The manufacturer or manufacturer's agent shipping the dialysate is licensed as a wholesaler or other drug distributor;
2. (2) The dialysate is stored and delivered in the original, sealed, and labeled package from the manufacturing facility; and

3. (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.

Source: 47 SDR 42, effective October 12, 2020.

General Authority: SDCL 36-11-11(1).

Law Implemented: SDCL 36-11-11(1) .