Exceptions.

(1) This chapter shall not be construed to prohibit the sale of home remedies or preparations commonly known as patents or proprietary preparations when sold only in original or unbroken packages, nor shall this chapter be construed to prevent businesses from engaging in the sale of sundries or patents or proprietary preparations.

(2) This chapter does not apply to a manufacturer, or its agent, holding an active manufacturer or third-party logistics provider permit under chapter 499, to the extent the manufacturer, or its agent, is engaged in the manufacture or distribution of dialysate, drugs, or devices necessary to perform home renal dialysis on patients with chronic kidney failure, if the dialysate, drugs, or devices are:

(a) Approved or cleared by the United States Food and Drug Administration; and

(b) Delivered in the original, sealed packaging after receipt of a physician’s order to dispense to:

1. A patient with chronic kidney failure, or the patient’s designee, for the patient’s self-administration of the dialysis therapy; or

2. A health care practitioner or an institution for administration or delivery of the dialysis therapy to a patient with chronic kidney failure.