Florida Senate - 2012                        COMMITTEE AMENDMENT
       Bill No. SB 1006
                                Barcode 942294                          
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  02/27/2012           .                                

       The Committee on Health Regulation (Norman) recommended the
    1         Senate Amendment to Amendment (416374) (with directory and
    2  title amendments)
    4         Between lines 56 and 57
    5  insert:
    6         (54) “Wholesale distribution” means distribution of
    7  prescription drugs to persons other than a consumer or patient,
    8  but does not include:
    9         (a) Any of the following activities, which is not a
   10  violation of s. 499.005(21) if such activity is conducted in
   11  accordance with s. 499.01(2)(g):
   12         1. The purchase or other acquisition by a hospital or other
   13  health care entity that is a member of a group purchasing
   14  organization of a prescription drug for its own use from the
   15  group purchasing organization or from other hospitals or health
   16  care entities that are members of that organization.
   17         2. The sale, purchase, or trade of a prescription drug or
   18  an offer to sell, purchase, or trade a prescription drug by a
   19  charitable organization described in s. 501(c)(3) of the
   20  Internal Revenue Code of 1986, as amended and revised, to a
   21  nonprofit affiliate of the organization to the extent otherwise
   22  permitted by law.
   23         3. The sale, purchase, or trade of a prescription drug or
   24  an offer to sell, purchase, or trade a prescription drug among
   25  hospitals or other health care entities that are under common
   26  control. For purposes of this subparagraph, “common control”
   27  means the power to direct or cause the direction of the
   28  management and policies of a person or an organization, whether
   29  by ownership of stock, by voting rights, by contract, or
   30  otherwise.
   31         4. The sale, purchase, trade, or other transfer of a
   32  prescription drug from or for any federal, state, or local
   33  government agency or any entity eligible to purchase
   34  prescription drugs at public health services prices pursuant to
   35  Pub. L. No. 102-585, s. 602 to a contract provider or its
   36  subcontractor for eligible patients of the agency or entity
   37  under the following conditions:
   38         a. The agency or entity must obtain written authorization
   39  for the sale, purchase, trade, or other transfer of a
   40  prescription drug under this subparagraph from the State Surgeon
   41  General or his or her designee.
   42         b. The contract provider or subcontractor must be
   43  authorized by law to administer or dispense prescription drugs.
   44         c. In the case of a subcontractor, the agency or entity
   45  must be a party to and execute the subcontract.
   46         d. A contract provider or subcontractor must maintain
   47  separate and apart from other prescription drug inventory any
   48  prescription drugs of the agency or entity in its possession.
   49         d.e. The contract provider and subcontractor must maintain
   50  and produce immediately for inspection all records of movement
   51  or transfer of all the prescription drugs belonging to the
   52  agency or entity, including, but not limited to, the records of
   53  receipt and disposition of prescription drugs. Each contractor
   54  and subcontractor dispensing or administering these drugs must
   55  maintain and produce records documenting the dispensing or
   56  administration. Records that are required to be maintained
   57  include, but are not limited to, a perpetual inventory itemizing
   58  drugs received and drugs dispensed by prescription number or
   59  administered by patient identifier, which must be submitted to
   60  the agency or entity quarterly.
   61         e.f. The contract provider or subcontractor may administer
   62  or dispense the prescription drugs only to the eligible patients
   63  of the agency or entity or must return the prescription drugs
   64  for or to the agency or entity. The contract provider or
   65  subcontractor must require proof from each person seeking to
   66  fill a prescription or obtain treatment that the person is an
   67  eligible patient of the agency or entity and must, at a minimum,
   68  maintain a copy of this proof as part of the records of the
   69  contractor or subcontractor required under sub-subparagraph d
   70  sub-subparagraph e.
   71         f.g. In addition to the departmental inspection authority
   72  set forth in s. 499.051, the establishment of the contract
   73  provider and subcontractor and all records pertaining to
   74  prescription drugs subject to this subparagraph shall be subject
   75  to inspection by the agency or entity. All records relating to
   76  prescription drugs of a manufacturer under this subparagraph
   77  shall be subject to audit by the manufacturer of those drugs,
   78  without identifying individual patient information.
   80  ====== D I R E C T O R Y  C L A U S E  A M E N D M E N T ======
   81         And the directory clause is amended as follows:
   82         Delete line 5
   83  and insert:
   84         Section 1. Subsections (17), (19), (20), and (43), and
   85  paragraph (a) of subsection (54) of
   87  ================= T I T L E  A M E N D M E N T ================
   88         And the title is amended as follows:
   89         Delete lines 267 - 268
   90  and insert:
   91         “distribution,” “drug,” “establishment,” “prescription
   92         drug,” and “wholesale distribution”; amending s.
   93         499.01, F.S.;