Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 762
       
       
       
       
       
       
                                Barcode 772464                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 4/AD/2R         .                                
             03/08/2012 02:17 PM       .                                
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       Senator Hays moved the following:
       
    1         Senate Amendment (with directory and title amendments)
    2  
    3         Between lines 907 and 908
    4  insert:
    5         (54) “Wholesale distribution” means distribution of
    6  prescription drugs to persons other than a consumer or patient,
    7  but does not include:
    8         (a) Any of the following activities, which is not a
    9  violation of s. 499.005(21) if such activity is conducted in
   10  accordance with s. 499.01(2)(g):
   11         1. The purchase or other acquisition by a hospital or other
   12  health care entity that is a member of a group purchasing
   13  organization of a prescription drug for its own use from the
   14  group purchasing organization or from other hospitals or health
   15  care entities that are members of that organization.
   16         2. The sale, purchase, or trade of a prescription drug or
   17  an offer to sell, purchase, or trade a prescription drug by a
   18  charitable organization described in s. 501(c)(3) of the
   19  Internal Revenue Code of 1986, as amended and revised, to a
   20  nonprofit affiliate of the organization to the extent otherwise
   21  permitted by law.
   22         3. The sale, purchase, or trade of a prescription drug or
   23  an offer to sell, purchase, or trade a prescription drug among
   24  hospitals or other health care entities that are under common
   25  control. For purposes of this subparagraph, “common control”
   26  means the power to direct or cause the direction of the
   27  management and policies of a person or an organization, whether
   28  by ownership of stock, by voting rights, by contract, or
   29  otherwise.
   30         4. The sale, purchase, trade, or other transfer of a
   31  prescription drug from or for any federal, state, or local
   32  government agency or any entity eligible to purchase
   33  prescription drugs at public health services prices pursuant to
   34  Pub. L. No. 102-585, s. 602 to a contract provider or its
   35  subcontractor for eligible patients of the agency or entity
   36  under the following conditions:
   37         a. The agency or entity must obtain written authorization
   38  for the sale, purchase, trade, or other transfer of a
   39  prescription drug under this subparagraph from the State Surgeon
   40  General or his or her designee.
   41         b. The contract provider or subcontractor must be
   42  authorized by law to administer or dispense prescription drugs.
   43         c. In the case of a subcontractor, the agency or entity
   44  must be a party to and execute the subcontract.
   45         d. A contract provider or subcontractor must maintain
   46  separate and apart from other prescription drug inventory any
   47  prescription drugs of the agency or entity in its possession.
   48         d.e. The contract provider and subcontractor must maintain
   49  and produce immediately for inspection all records of movement
   50  or transfer of all the prescription drugs belonging to the
   51  agency or entity, including, but not limited to, the records of
   52  receipt and disposition of prescription drugs. Each contractor
   53  and subcontractor dispensing or administering these drugs must
   54  maintain and produce records documenting the dispensing or
   55  administration. Records that are required to be maintained
   56  include, but are not limited to, a perpetual inventory itemizing
   57  drugs received and drugs dispensed by prescription number or
   58  administered by patient identifier, which must be submitted to
   59  the agency or entity quarterly.
   60         e.f. The contract provider or subcontractor may administer
   61  or dispense the prescription drugs only to the eligible patients
   62  of the agency or entity or must return the prescription drugs
   63  for or to the agency or entity. The contract provider or
   64  subcontractor must require proof from each person seeking to
   65  fill a prescription or obtain treatment that the person is an
   66  eligible patient of the agency or entity and must, at a minimum,
   67  maintain a copy of this proof as part of the records of the
   68  contractor or subcontractor required under sub-subparagraph d
   69  sub-subparagraph e.
   70         f.g. In addition to the departmental inspection authority
   71  set forth in s. 499.051, the establishment of the contract
   72  provider and subcontractor and all records pertaining to
   73  prescription drugs subject to this subparagraph shall be subject
   74  to inspection by the agency or entity. All records relating to
   75  prescription drugs of a manufacturer under this subparagraph
   76  shall be subject to audit by the manufacturer of those drugs,
   77  without identifying individual patient information.
   78  
   79  ====== D I R E C T O R Y  C L A U S E  A M E N D M E N T ======
   80         And the directory clause is amended as follows:
   81         Delete line 856
   82  and insert:
   83         Section 35. Subsections (17), (19), (20), and (43), and
   84  paragraph (a) of subsection (54) of
   85  
   86  ================= T I T L E  A M E N D M E N T ================
   87         And the title is amended as follows:
   88         Delete line 76
   89  and insert:
   90         “establishment,” “prescription drug,” and “wholesale
   91         distribution”; amending s.