26-4-6. Provisions of chapter not applicable to facilities engaged solely in distribution of dialysate drugs or certain dialysis equipment under certain conditions.

The provisions of this chapter shall not apply to a facility engaged solely in the distribution of dialysate drugs, or devices necessary to perform home kidney dialysis to patients with end stage renal disease, provided that the following criteria are met:

The dialysate drugs, or devices are approved or cleared by the federal Food and Drug Administration as required by federal law;#

The dialysate drugs, or devices are lawfully held by a manufacturer or manufacturer’s agent that is properly registered with the board as a manufacturer or wholesale distributor;#

The dialysate drugs, or devices are held and delivered in their original, sealed packaging from the manufacturing facility;#

The dialysate drugs, or devices are delivered only by the manufacturer or the manufacturer’s agent and only upon receipt of a physician’s order; and#

The manufacturer or manufacturer’s agent delivers the dialysate drugs, or devices directly to:#

1. (A)

   A patient with end stage renal disease or such patient’s designee for the patient’s self-administration of the dialysis therapy; or#

2. (B)

   A health care provider or institution for administration or delivery of the dialysis therapy to a patient with end stage renal disease.#