(d) This article may not be construed to prevent, restrict or in any manner interfere with the sale or distribution of dialysate, drugs or devices necessary to perform home peritoneal renal dialysis to patients with end state renal disease, nor may any legislative rule be adopted by the board which shall require the sale or distribution of such peritoneal dialysis products by a licensed pharmacist or in a pharmacy, provided the following criteria are met:
- (1) The dialysate, drugs or devices are approved or cleared by the Food and Drug Administration, as required by federal law.
- (2) The dialysate, drugs or devices are lawfully held by a manufacturer or a manufacturer’s agent that has obtained the proper permit from the board as a manufacturer or wholesale distributor, or third-party logistics provider.
- (3) The dialysate, drugs or devices are held and delivered in their original, sealed packaging from the manufacturing facility.
- (4) The dialysate, drugs or devices are delivered only upon receipt of a physician’s prescription by a licensed pharmacy, and the transmittal of an order from the licensed pharmacy to the manufacturer or the manufacturer’s agent; and
(5) The manufacturer or a manufacturer’s agent delivers the dialysate, drugs, or devices directly to:
- (A) A patient with chronic kidney failure, or his/her designee, for the patient’s self-administration of the dialysis therapy; or
- (B) A health care provider or institution for administration or delivery of the dialysis therapy to a patient with chronic kidney failure.