November 14, 2019
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       Florida Senate - 2010         (PROPOSED COMMITTEE BILL) SPB 7050
       
       
       
       FOR CONSIDERATION By the Committee on Health Regulation
       
       
       
       
       588-01616A-10                                         20107050__
    1                        A bill to be entitled                      
    2         An act relating to blood establishments; amending s.
    3         381.06014, F.S.; prohibiting local governments from
    4         restricting access to public facilities or
    5         infrastructure for certain activities based on whether
    6         a blood establishment is operating as a for-profit
    7         organization or not-for-profit organization;
    8         prohibiting a blood establishment from considering
    9         whether certain customers are operating as a for
   10         profit organization or not-for-profit organization
   11         when determining prices for selling blood or blood
   12         components; amending s. 499.005, F.S.; clarifying
   13         provisions prohibiting the unauthorized wholesale
   14         distribution of a prescription drug that was purchased
   15         by a hospital or other health care entity, to conform
   16         to changes made by the act; amending s. 499.01, F.S.;
   17         requiring certain blood establishments to obtain a
   18         restricted prescription drug distributor permit under
   19         specified conditions; providing an effective date.
   20  
   21  Be It Enacted by the Legislature of the State of Florida:
   22  
   23         Section 1. Subsections (5) and (6) are added to section
   24  381.06014, Florida Statutes, to read:
   25         381.06014 Blood establishments.—
   26         (5) A local government may not restrict the access to or
   27  use of any public facility or infrastructure for the collection
   28  of blood or blood components from volunteer donors based on
   29  whether the blood establishment is operating as a for-profit
   30  organization or not-for-profit organization.
   31         (6) In determining the price of blood or blood components
   32  that are received from volunteer donors and sold to hospitals or
   33  other health care providers, a blood establishment may not base
   34  the price of the blood or blood component solely on whether the
   35  purchasing entity is a for-profit organization or not-for-profit
   36  organization.
   37         Section 2. Subsection (21) of section 499.005, Florida
   38  Statutes, is amended to read:
   39         499.005 Prohibited acts.—It is unlawful for a person to
   40  perform or cause the performance of any of the following acts in
   41  this state:
   42         (21) The wholesale distribution of any prescription drug
   43  that was:
   44         (a) Purchased by a public or private hospital or other
   45  health care entity, except as authorized in s. 499.01(2)(g); or
   46         (b) Donated or supplied at a reduced price to a charitable
   47  organization.
   48         Section 3. Paragraph (g) of subsection (2) of section
   49  499.01, Florida Statutes, is amended to read:
   50         499.01 Permits.—
   51         (2) The following permits are established:
   52         (g) Restricted prescription drug distributor permit.—
   53         1. A restricted prescription drug distributor permit is
   54  required for:
   55         a. Any person that engages in the distribution of a
   56  prescription drug, which distribution is not considered
   57  “wholesale distribution” under s. 499.003(53)(a).
   58         b.1.Any A person who engages in the receipt or
   59  distribution of a prescription drug in this state for the
   60  purpose of processing its return or its destruction must obtain
   61  a permit as a restricted prescription drug distributor if such
   62  person is not the person initiating the return, the prescription
   63  drug wholesale supplier of the person initiating the return, or
   64  the manufacturer of the drug.
   65         c.A blood establishment located in this state which
   66  collects blood and blood components only from volunteer donors
   67  and which engages in the wholesale distribution of a
   68  prescription drug to a health care entity. The blood
   69  establishment must operate in accordance with s. 381.06014. The
   70  blood establishment shall distribute only:
   71         (I) Prescription drugs indicated for a bleeding or clotting
   72  disorder or anemia;
   73         (II) Blood-collection containers approved under s. 505 of
   74  the federal act; or
   75         (III) Drugs that are blood derivatives, blood recombinants,
   76  or synthetic forms of a blood derivative,
   77  
   78  as long as all of the health care services that the blood
   79  establishment provides are related to its activities as a
   80  registered blood establishment or the health care services
   81  consist of collecting, processing, storing, or administering
   82  human hematopoietic stem cells or progenitor cells or performing
   83  diagnostic testing of specimens if these specimens are tested
   84  together with specimens undergoing routine donor testing.
   85         2. Storage, handling, and recordkeeping of these
   86  distributions by a person permitted as a restricted prescription
   87  drug distributor must comply with the requirements for wholesale
   88  distributors under s. 499.0121, but not those set forth in s.
   89  499.01212 if the distribution occurs pursuant to sub
   90  subparagraph 1.a. or sub-subparagraph 1.b.
   91         3. A person who applies for a permit as a restricted
   92  prescription drug distributor, or for the renewal of such a
   93  permit, must provide to the department the information required
   94  under s. 499.012.
   95         4. The department may adopt rules regarding the
   96  distribution of prescription drugs by hospitals, health care
   97  entities, charitable organizations, or other persons not
   98  involved in wholesale distribution, which rules are necessary
   99  for the protection of the public health, safety, and welfare.
  100         Section 4. This act shall take effect July 1, 2010.

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