Florida Senate - 2018 COMMITTEE AMENDMENT Bill No. SB 1252 Ì927006ÆÎ927006 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Passidomo) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Subsection (2) of section 465.027, Florida 6 Statutes, is amended to read: 7 465.027 Exceptions.— 8 (2) This chapter does
shallnot apply to a manufacturer, or 9 its agent, holding an active manufacturer or third-party 10 logistics provider permit as a manufacturerunder chapter 499, 11 to the extent the manufacturer, or its agent, is andengaged 12 solelyin the manufacture or distribution of dialysate, drugs, 13 or devices necessary to perform home renal dialysis on patients 14 with chronic kidney failure, if the dialysate, drugs, or devices 15 are: 16 (a) Approved or cleared by the United States Food and Drug 17 Administration; and 18 (b) Delivered in the original, sealed packaging after 19 receipt of a physician’s order to dispense to: 20 1. A patient with chronic kidney failure, or the patient’s 21 designee, for the patient’s self-administration of the dialysis 22 therapy; or 23 2. A health care practitioner or an institution for 24 administration or delivery of the dialysis therapy to a patient 25 with chronic kidney failure. 26 Section 2. This act shall take effect upon becoming a law. 27 ================= T I T L E A M E N D M E N T ================ 28 And the title is amended as follows: 29 Delete everything before the enacting clause 30 and insert: 31 A bill to be entitled 32 An act relating to distributing pharmaceutical drugs 33 and devices; amending s. 465.027, F.S.; revising an 34 exception to pharmacy regulations for certain 35 manufacturers and distributors of dialysis drugs or 36 supplies; providing an effective date.