Florida Senate - 2018 SB 1252 By Senator Passidomo 28-01376-18 20181252__ 1 A bill to be entitled 2 An act relating to home renal dialysis; amending s. 3 465.027, F.S.; revising conditions under which 4 manufacturers, or agents thereof, who distribute home 5 dialysis supplies are exempt from the requirements of 6 the Florida Pharmacy Act; providing an effective date. 7 8 Be It Enacted by the Legislature of the State of Florida: 9 10 Section 1. Subsection (2) of section 465.027, Florida 11 Statutes, is amended to read: 12 465.027 Exceptions.— 13 (2) This chapter does
shallnot apply to a manufacturer, or 14 its agent, holding an active manufacturer or third party 15 logistics permit as a manufacturerunder chapter 499 who is and16 engaged solelyin the manufacture ordistribution of dialysate, 17 drugs, or devices necessary to perform home renal dialysis on 18 patients with chronic kidney failure, if the dialysate, drugs, 19 or devices are: 20 (a) Approved or cleared by the United States Food and Drug 21 Administration; and 22 (b) Delivered in the original, sealed packaging after 23 receipt of a physician’s order to dispense to: 24 1. A patient with chronic kidney failure, or the patient’s 25 designee, for the patient’s self-administration of the dialysis 26 therapy; or 27 2. A health care practitioner or an institution for 28 administration or delivery of the dialysis therapy to a patient 29 with chronic kidney failure. 30 Section 2. This act shall take effect July 1, 2018.