(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
Terms Used In Florida Statutes 465.027
- Administration: means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption. See Florida Statutes 465.003
- Dispense: means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. See Florida Statutes 465.003
- drugs: means those substances or preparations commonly known as "prescription" or "legend" drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined. See Florida Statutes 465.003
(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.