Florida Senate - 2012                        COMMITTEE AMENDMENT
       Bill No. SB 1006
       
       
       
       
       
       
                                Barcode 790972                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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       The Committee on Health Regulation (Diaz de la Portilla)
       recommended the following:
       
    1         Senate Amendment to Amendment (416374) (with directory and
    2  title amendments)
    3  
    4         Between lines 256 and 257
    5  insert:
    6         (4) A prescription drug repackager permit issued under this
    7  part is not required for a restricted prescription drug
    8  distributor permitholder that is a health care entity that
    9  repackages prescription drugs in this state for its own use or
   10  distributes prescription drugs to a hospital or other health
   11  care entity in the state for its own use pursuant to s.
   12  499.003(54)(a)3. if the restricted prescription drug
   13  distributor:
   14         (a) Notifies the department in writing of its intention to
   15  engage in repackaging under this exemption 30 days before
   16  actually engaging in the repackaging of prescription drugs at
   17  the permitted establishment;
   18         (b) Is under common control with the hospital or other
   19  health care entity to which the restricted prescription drug
   20  distributor distributes prescription drugs. For purposes of this
   21  paragraph, the term “common control” means the power to direct
   22  or cause the direction of the management and policies of a
   23  person or an organization, whether by ownership of stock, by
   24  voting rights, by contract, or otherwise;
   25         (c) Repackages the prescription drugs in accordance with
   26  proper manufacturing practices and current state and federal
   27  laws and rules; and
   28         (d) Labels the prescription drugs in accordance with state
   29  and federal laws and rules.
   30  
   31  The restricted prescription drug distributor is exempt from the
   32  product registration requirements of s. 499.015 with regard to
   33  the prescription drugs that it repackages and distributes under
   34  this 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 58 - 59
   39  and insert:
   40         Section 499.01, Florida Statutes, are amended, and
   41  subsections (3) and (4) are added to that section, to read:
   42  
   43  ================= T I T L E  A M E N D M E N T ================
   44         And the title is amended as follows:
   45         Delete line 337
   46  and insert:
   47         relating to controlled substances; providing that a
   48         prescription drug repackager permit is not required
   49         for certain restricted prescription drug distributor
   50         permitholders that distribute prescription drugs to
   51         certain hospitals or other health care entities;
   52         exempting certain restricted prescription drug
   53         distributors from product registration requirements;
   54         providing an