Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 762
       
       
       
       
       
       
                                Barcode 480546                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 5/AD/2R         .                                
             03/08/2012 02:17 PM       .                                
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       Senator Hays moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 1001 and 1002
    4  insert:
    5         (3)(a) A nonresident prescription drug manufacturer permit
    6  is not required for a manufacturer to distribute a prescription
    7  drug active pharmaceutical ingredient that it manufactures to a
    8  prescription drug manufacturer permitted in this state in
    9  limited quantities intended for research and development and not
   10  for resale or human use other than lawful clinical trials and
   11  biostudies authorized and regulated by federal law. A
   12  manufacturer claiming to be exempt from the permit requirements
   13  of this paragraph and the prescription drug manufacturer
   14  purchasing and receiving the active pharmaceutical ingredient
   15  shall comply with the recordkeeping requirements of s.
   16  499.0121(6), but not the requirements of s. 499.01212. The
   17  prescription drug manufacturer purchasing and receiving the
   18  active pharmaceutical ingredient shall maintain on file a record
   19  of the FDA registration number; if available, the out-of-state
   20  license, permit, or registration number; and, if available, a
   21  copy of the most current FDA inspection report, for all
   22  manufacturers from whom they purchase active pharmaceutical
   23  ingredients under this section. The department shall define the
   24  term “limited quantities” by rule, and may include the allowable
   25  number of transactions within a given period of time and the
   26  amount of prescription drugs distributed into the state for
   27  purposes of this exemption. The failure to comply with the
   28  requirements of this paragraph, or rules adopted by the
   29  department to administer this paragraph, for the purchase of
   30  prescription drug active pharmaceutical ingredients is a
   31  violation of s. 499.005(14), and a knowing failure is a
   32  violation of s. 499.0051(4).
   33  
   34         (Redesignate subsequent paragraphs)
   35  
   36  ================= T I T L E  A M E N D M E N T ================
   37         And the title is amended as follows:
   38         Delete line 83
   39  and insert:
   40         prescription drugs; providing an exemption from permit
   41         requirements for the distribution into this state of
   42         prescription drug active pharmaceutical ingredients
   43         intended for research and development; requiring
   44         compliance with certain recordkeeping requirements;
   45         providing for a definition; providing for penalties;
   46         providing an exemption from permit