October 23, 2019
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       Florida Senate - 2010                                    SB 2300
       
       
       
       By Senator Altman
       
       
       
       
       24-00452A-10                                          20102300__
    1                        A bill to be entitled                      
    2         An act relating to health care facilities; amending s.
    3         395.002, F.S.; redefining the term “accrediting
    4         organization” as used in ch. 395, F.S., relating to
    5         hospitals and other licensed facilities, to include
    6         other accrediting organizations that have been
    7         approved by the Federal Government for purposes of the
    8         Medicare program; amending s. 499.003, F.S.;
    9         redefining the term “wholesale distribution” as it
   10         relates to the sale, purchase, or trade of a
   11         prescription drug from certain eligible entities to a
   12         contract provider or its subcontractor; providing an
   13         effective date.
   14  
   15  Be It Enacted by the Legislature of the State of Florida:
   16  
   17         Section 1. Subsection (1) of section 395.002, Florida
   18  Statutes, is amended to read:
   19         395.002 Definitions.—As used in this chapter:
   20         (1) “Accrediting organizations” means the Joint Commission
   21  on Accreditation of Healthcare Organizations, the American
   22  Osteopathic Association, the Commission on Accreditation of
   23  Rehabilitation Facilities, and the Accreditation Association for
   24  Ambulatory Health Care, Inc., and other accrediting
   25  organizations that have been approved by the Federal Government
   26  for purposes of the Medicare program.
   27         Section 2. Paragraph (a) of subsection (53) of section
   28  499.003, Florida Statutes, is amended to read:
   29         499.003 Definitions of terms used in this part.—As used in
   30  this part, the term:
   31         (53) “Wholesale distribution” means distribution of
   32  prescription drugs to persons other than a consumer or patient,
   33  but does not include:
   34         (a) Any of the following activities, which is not a
   35  violation of s. 499.005(21) if such activity is conducted in
   36  accordance with s. 499.01(2)(g):
   37         1. The purchase or other acquisition by a hospital or other
   38  health care entity that is a member of a group purchasing
   39  organization of a prescription drug for its own use from the
   40  group purchasing organization or from other hospitals or health
   41  care entities that are members of that organization.
   42         2. The sale, purchase, or trade of a prescription drug or
   43  an offer to sell, purchase, or trade a prescription drug by a
   44  charitable organization described in s. 501(c)(3) of the
   45  Internal Revenue Code of 1986, as amended and revised, to a
   46  nonprofit affiliate of the organization to the extent otherwise
   47  permitted by law.
   48         3. The sale, purchase, or trade of a prescription drug or
   49  an offer to sell, purchase, or trade a prescription drug among
   50  hospitals or other health care entities that are under common
   51  control. For purposes of this subparagraph, “common control”
   52  means the power to direct or cause the direction of the
   53  management and policies of a person or an organization, whether
   54  by ownership of stock, by voting rights, by contract, or
   55  otherwise.
   56         4. The sale, purchase, trade, or other transfer of a
   57  prescription drug from or for any federal, state, or local
   58  government agency or any entity eligible to purchase
   59  prescription drugs at public health services prices pursuant to
   60  Pub. L. No. 102-585, s. 602 to a contract provider or its
   61  subcontractor for eligible patients of the agency or entity
   62  under the following conditions:
   63         a. The agency or entity must obtain written authorization
   64  for the sale, purchase, trade, or other transfer of a
   65  prescription drug under this subparagraph from the State Surgeon
   66  General or his or her designee.
   67         b. The contract provider or subcontractor must be
   68  authorized by law to administer or dispense prescription drugs.
   69         c. In the case of a subcontractor, the agency or entity
   70  must be a party to and execute the subcontract.
   71         d.A contract provider or subcontractor must maintain
   72  separate and apart from other prescription drug inventory any
   73  prescription drugs of the agency or entity in its possession.
   74         d.e. The contract provider and subcontractor must maintain
   75  and produce immediately for inspection all records of movement
   76  or transfer of all the prescription drugs belonging to the
   77  agency or entity, including, but not limited to, the records of
   78  receipt and disposition of prescription drugs. Each contractor
   79  and subcontractor dispensing or administering these drugs must
   80  maintain and produce records documenting the dispensing or
   81  administration. Records that are required to be maintained
   82  include, but are not limited to, a perpetual inventory itemizing
   83  drugs received and drugs dispensed by prescription number or
   84  administered by patient identifier, which must be submitted to
   85  the agency or entity quarterly.
   86         e.f. The contract provider or subcontractor may administer
   87  or dispense the prescription drugs only to the eligible patients
   88  of the agency or entity or must return the prescription drugs
   89  for or to the agency or entity. The contract provider or
   90  subcontractor must require proof from each person seeking to
   91  fill a prescription or obtain treatment that the person is an
   92  eligible patient of the agency or entity and must, at a minimum,
   93  maintain a copy of this proof as part of the records of the
   94  contractor or subcontractor required under sub-subparagraph d.
   95  e.
   96         f.g. In addition to the departmental inspection authority
   97  set forth in s. 499.051, the establishment of the contract
   98  provider and subcontractor and all records pertaining to
   99  prescription drugs subject to this subparagraph shall be subject
  100  to inspection by the agency or entity. All records relating to
  101  prescription drugs of a manufacturer under this subparagraph
  102  shall be subject to audit by the manufacturer of those drugs,
  103  without identifying individual patient information.
  104         Section 3. This act shall take effect July 1, 2010.
  105  

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