Florida Senate - 2018                        COMMITTEE AMENDMENT
       Bill No. SB 1252
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       The Committee on Health Policy (Passidomo) recommended the
    1         Senate Amendment (with title amendment)
    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 shall not apply to a manufacturer, or
    9  its agent, holding an active manufacturer or third-party
   10  logistics provider permit as a manufacturer under chapter 499,
   11  to the extent the manufacturer, or its agent, is and engaged
   12  solely in 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.