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 shall not apply to a manufacturer, or
   14  its agent, holding an active manufacturer or third party
   15  logistics permit as a manufacturer under chapter 499 who is and
   16  engaged solely in the manufacture or distribution 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.