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.
    8  Be It Enacted by the Legislature of the State of Florida:
   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 shall not apply to a manufacturer, or
   14  its agent, holding an active manufacturer or third-party
   15  logistics provider permit as a manufacturer under chapter 499,
   16  to the extent the manufacturer, or its agent, is and engaged
   17  solely in 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.