Florida Senate - 2020                          SENATOR AMENDMENT
       Bill No. CS/CS/CS/SB 512, 1st Eng.
       
       
       
       
       
       
                                Ì114166*Î114166                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/AD/3R         .                                
             03/05/2020 04:05 PM       .                                
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       Senator Hutson moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 354 and 355
    4  insert:
    5         Section 2. Paragraph (d) of subsection (1) of section
    6  499.012, Florida Statutes, is amended to read:
    7         499.012 Permit application requirements.—
    8         (1)
    9         (d) A permit for a prescription drug manufacturer,
   10  prescription drug repackager, prescription drug wholesale
   11  distributor, limited prescription drug veterinary wholesale
   12  distributor, or retail pharmacy drug wholesale distributor may
   13  not be issued to the address of a health care entity or to a
   14  pharmacy licensed under chapter 465, except as provided in this
   15  paragraph. The department may issue a prescription drug
   16  manufacturer permit to a nonembryonic stem cell bank that is
   17  licensed by the Agency for Health Care Administration pursuant
   18  to s. 400.991 and part II of chapter 408. The department may
   19  issue a prescription drug manufacturer permit to an applicant at
   20  the same address as a licensed nuclear pharmacy, which is a
   21  health care entity, even if the nuclear pharmacy holds a special
   22  sterile compounding permit under chapter 465, for the purpose of
   23  manufacturing prescription drugs used in positron emission
   24  tomography or other radiopharmaceuticals, as listed in a rule
   25  adopted by the department pursuant to this paragraph. The
   26  purpose of this exemption is to assure availability of state-of
   27  the-art pharmaceuticals that would pose a significant danger to
   28  the public health if manufactured at a separate establishment
   29  address from the nuclear pharmacy from which the prescription
   30  drugs are dispensed. The department may also issue a retail
   31  pharmacy drug wholesale distributor permit to the address of a
   32  community pharmacy licensed under chapter 465, even if the
   33  community pharmacy holds a special sterile compounding permit
   34  under chapter 465, as long as the community pharmacy does not
   35  meet the definition of a closed pharmacy in s. 499.003.
   36  
   37  ================= T I T L E  A M E N D M E N T ================
   38  And the title is amended as follows:
   39         Delete line 23
   40  and insert:
   41         Regulation, to adopt specified rules; amending s.
   42         499.012, F.S.; authorizing the Department of Business
   43         and Professional Regulation to issue a prescription
   44         drug manufacturer permit to a certain nonembryonic
   45         stem cell bank; providing an