Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 762
       
       
       
       
       
       
                                Barcode 137814                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 8/AD/2R         .                                
             03/08/2012 02:23 PM       .                                
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       Senator Hays moved the following:
       
    1         Senate Amendment (with directory and title amendments)
    2  
    3         Between lines 1107 and 1108
    4  insert:
    5         (4) A prescription drug repackager permit issued under this
    6  part is not required for a restricted prescription drug
    7  distributor permitholder that is a health care entity to
    8  repackage prescription drugs in this state for its own use or
    9  for distribution to hospitals or other health care entities in
   10  the state for their own use, pursuant to s. 499.003(54)(a)3.,
   11  if:
   12         (a) The prescription drug distributor notifies the
   13  department, in writing, of its intention to engage in
   14  repackaging under this exemption, 30 days before engaging in the
   15  repackaging of prescription drugs at the permitted
   16  establishment;
   17         (b) The prescription drug distributor is under common
   18  control with the hospitals or other health care entities to
   19  which the prescription drug distributor is distributing
   20  prescription drugs. As used in this paragraph, “common control”
   21  means the power to direct or cause the direction of the
   22  management and policies of a person or an organization, whether
   23  by ownership of stock, voting rights, contract, or otherwise;
   24         (c) The prescription drug distributor repackages the
   25  prescription drugs in accordance with current state and federal
   26  good manufacturing practices; and
   27         (d) The prescription drug distributor labels the
   28  prescription drug it repackages in accordance with state and
   29  federal laws and rules.
   30  
   31  The prescription drug distributor is exempt from the product
   32  registration requirements of s. 499.015, with regard to the
   33  prescription drugs that it repackages and distributes under this
   34  subsection.
   35  
   36  ====== D I R E C T O R Y  C L A U S E  A M E N D M E N T ======
   37         And the directory clause is amended as follows:
   38         Delete lines 908 - 910
   39  and insert:
   40         Section 36. Paragraphs (c) and (e) of subsection (2) of
   41  section 499.01, Florida Statutes, are amended, and subsections
   42  (3) and (4) are added to that section, to read:
   43  
   44  ================= T I T L E  A M E N D M E N T ================
   45         And the title is amended as follows:
   46         Delete line 146
   47  and insert:
   48         controlled substances; exempting certain prescription
   49         drug repackagers from permit requirements if they
   50         repackage prescription drugs for their own use or for
   51         certain related entities; providing notification
   52         requirements; exempting such repackagers from product
   53         registration requirements; providing an effective
   54         date.