Florida Senate - 2018 CS for SB 1252 By the Committee on Health Policy; and Senator Passidomo 588-02385-18 20181252c1 1 A bill to be entitled 2 An act relating to distributing pharmaceutical drugs 3 and devices; amending s. 465.027, F.S.; revising an 4 exception to pharmacy regulations for certain 5 manufacturers and distributors of dialysis drugs or 6 supplies; 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 provider permit as a manufacturerunder chapter 499, 16 to the extent the manufacturer, or its agent, is andengaged 17 solelyin the manufacture or distribution of dialysate, drugs, 18 or devices necessary to perform home renal dialysis on patients 19 with chronic kidney failure, if the dialysate, drugs, or devices 20 are: 21 (a) Approved or cleared by the United States Food and Drug 22 Administration; and 23 (b) Delivered in the original, sealed packaging after 24 receipt of a physician’s order to dispense to: 25 1. A patient with chronic kidney failure, or the patient’s 26 designee, for the patient’s self-administration of the dialysis 27 therapy; or 28 2. A health care practitioner or an institution for 29 administration or delivery of the dialysis therapy to a patient 30 with chronic kidney failure. 31 Section 2. This act shall take effect upon becoming a law.