Florida Senate - 2012                        COMMITTEE AMENDMENT
       Bill No. SB 1006
                                Barcode 576758                          
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       The Committee on Health Regulation (Diaz de la Portilla)
       recommended the following:
    1         Senate Amendment (with directory and title amendments)
    3         Between lines 64 and 65
    4  insert:
    5         (3)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 that
    8  repackages prescription drugs in this state for its own use or
    9  distributes prescription drugs to a hospital or other health
   10  care entity in the state for its own use pursuant to s.
   11  499.003(54)(a)3. if the restricted prescription drug
   12  distributor:
   13         (a)Notifies the department in writing of its intention to
   14  engage in repackaging under this exemption 30 days before
   15  actually engaging in the repackaging of prescription drugs at
   16  the permitted establishment;
   17         (b)Is under common control with the hospital or other
   18  health care entity to which the restricted prescription drug
   19  distributor distributes prescription drugs. For purposes of this
   20  paragraph, the term “common control” means the power to direct
   21  or cause the direction of the management and policies of a
   22  person or an organization, whether by ownership of stock, by
   23  voting rights, by contract, or otherwise;
   24         (c)Repackages the prescription drugs in accordance with
   25  proper manufacturing practices and current state and federal
   26  laws and rules; and
   27         (d)Labels the prescription drugs in accordance with state
   28  and federal laws and rules.
   30  The restricted prescription drug distributor is exempt from the
   31  product registration requirements of s. 499.015 with regard to
   32  the prescription drugs that it repackages and distributes under
   33  this subsection.
   35  ====== D I R E C T O R Y  C L A U S E  A M E N D M E N T ======
   36         And the directory clause is amended as follows:
   37         Delete line 15
   38  and insert:
   39  499.01, Florida Statutes, is amended, and subsection (3) is
   40  added to that section, to read:
   42  ================= T I T L E  A M E N D M E N T ================
   43         And the title is amended as follows:
   44         Delete line 9
   45  and insert:
   46         that permit until its expiration; providing that a
   47         prescription drug repackager permit is not required
   48         for certain restricted prescription drug distributor
   49         permitholders that distribute prescription drugs to
   50         certain hospitals or other health care entities;
   51         exempting certain restricted prescription drug
   52         distributors from product registration requirements;
   53         providing an