(1) The dialysate drugs, or devices are approved or cleared by the federal Food and Drug Administration as required by federal law;
(2) 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;
(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 by the manufacturer or the manufacturer's agent and only upon receipt of a physician's order; and
(5) The manufacturer or manufacturer's agent delivers the dialysate drugs, or devices directly to:
(A) A patient with end stage renal disease or such patient's 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 end stage renal disease.
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