Florida Senate - 2011                                      SB 94
       By Senator Gaetz
       4-00007A-11                                             201194__
    1                        A bill to be entitled                      
    2         An act relating to blood establishments; amending s.
    3         381.06014, F.S.; defining the term “volunteer donor”;
    4         prohibiting local governments from restricting access
    5         to public facilities or infrastructure for certain
    6         activities based on whether a blood establishment is
    7         operating as a for-profit organization or not-for
    8         profit organization; prohibiting a blood establishment
    9         from considering whether certain customers are
   10         operating as for-profit organizations or not-for
   11         profit organizations when determining service fees for
   12         selling blood or blood components; requiring that
   13         certain blood establishments disclose specified
   14         information on the Internet; amending s. 483.201,
   15         F.S.; providing for disciplinary action against
   16         clinical laboratories that fail to disclose specified
   17         information on the Internet; providing a maximum
   18         annual administrative fine that may be imposed
   19         annually against certain clinical laboratories for
   20         failure to comply with such disclosure requirement;
   21         amending s. 499.003, F.S.; redefining the term “health
   22         care entity” to clarify that a blood establishment may
   23         be a health care entity and engage in certain
   24         activities; amending s. 499.005, F.S.; clarifying
   25         provisions prohibiting the unauthorized wholesale
   26         distribution of a prescription drug that was purchased
   27         by a hospital or other health care entity, to conform
   28         to changes made by the act; amending s. 499.01, F.S.;
   29         exempting certain blood establishments from the
   30         requirements to be permitted as a prescription drug
   31         manufacturer and register products; requiring that
   32         certain blood establishments obtain a restricted
   33         prescription drug distributor permit under specified
   34         conditions; limiting the prescription drugs that a
   35         blood establishment may distribute under a restricted
   36         prescription drug distributor permit; authorizing the
   37         Department of Health to adopt rules; providing an
   38         effective date.
   40  Be It Enacted by the Legislature of the State of Florida:
   42         Section 1. Section 381.06014, Florida Statutes, is amended
   43  to read:
   44         381.06014 Blood establishments.—
   45         (1) As used in this section, the term:
   46         (a) “Blood establishment” means any person, entity, or
   47  organization, operating within the state, which examines an
   48  individual for the purpose of blood donation or which collects,
   49  processes, stores, tests, or distributes blood or blood
   50  components collected from the human body for the purpose of
   51  transfusion, for any other medical purpose, or for the
   52  production of any biological product.
   53         (b) “Volunteer donor” means a person who does not receive
   54  remuneration, other than an incentive, for a blood donation
   55  intended for transfusion, and the product container of the
   56  donation from the person qualifies for labeling with the
   57  statement “volunteer donor” under 21 C.F.R. s. 606.121.
   58         (2) Any blood establishment operating in the state may not
   59  conduct any activity defined in paragraph (1)(a) subsection (1)
   60  unless that blood establishment is operated in a manner
   61  consistent with the provisions of Title 21 C.F.R. parts 211 and
   62  600-640, Code of Federal Regulations.
   63         (3) Any blood establishment determined to be operating in
   64  the state in a manner not consistent with the provisions of
   65  Title 21 C.F.R. parts 211 and 600-640, Code of Federal
   66  Regulations, and in a manner that constitutes a danger to the
   67  health or well-being of donors or recipients as evidenced by the
   68  federal Food and Drug Administration’s inspection reports and
   69  the revocation of the blood establishment’s license or
   70  registration is shall be in violation of this chapter and shall
   71  immediately cease all operations in the state.
   72         (4) The operation of a blood establishment in a manner not
   73  consistent with the provisions of Title 21 C.F.R. parts 211 and
   74  600-640, Code of Federal Regulations, and in a manner that
   75  constitutes a danger to the health or well-being of blood donors
   76  or recipients as evidenced by the federal Food and Drug
   77  Administration’s inspection process is declared a nuisance and
   78  inimical to the public health, welfare, and safety. The Agency
   79  for Health Care Administration or any state attorney may bring
   80  an action for an injunction to restrain such operations or
   81  enjoin the future operation of the blood establishment.
   82         (5) A local government may not restrict the access to or
   83  use of any public facility or infrastructure for the collection
   84  of blood or blood components from volunteer donors based on
   85  whether the blood establishment is operating as a for-profit
   86  organization or not-for-profit organization.
   87         (6) In determining the service fee of blood or blood
   88  components received from volunteer donors and sold to hospitals
   89  or other health care providers, a blood establishment may not
   90  base the service fee of the blood or blood component solely on
   91  whether the purchasing entity is a for-profit organization or
   92  not-for-profit organization.
   93         (7) A blood establishment that collects blood or blood
   94  components from volunteer donors must disclose on the Internet
   95  information to educate and inform donors and the public about
   96  the blood establishment’s activities. A hospital that collects
   97  blood or blood components from volunteer donors for its own use
   98  or for health care providers that are part of its business
   99  entity is exempt from the disclosure requirements in this
  100  subsection. The information required to be disclosed under this
  101  subsection may be cumulative for all blood establishments within
  102  a business entity. Disciplinary action against the blood
  103  establishment’s clinical laboratory license may be taken as
  104  provided in s. 483.201 for a blood establishment that is
  105  required to disclose but fails to disclose on its website all of
  106  the following information:
  107         (a) A description of the steps involved in collecting,
  108  processing, and distributing volunteer donations, presented in a
  109  manner appropriate for the donating public.
  110         (b) By March 1 of each year, the number of units of blood
  111  components, identified by component, which were:
  112         1. Produced by the blood establishment during the preceding
  113  calendar year;
  114         2. Obtained from other sources during the preceding
  115  calendar year;
  116         3. Distributed during the preceding year to health care
  117  providers located outside this state. However, if the blood
  118  establishment collects donations in a county outside this state,
  119  distributions to health care providers in that county shall be
  120  excluded. Such information shall be aggregated by health care
  121  providers located within the United States and its territories
  122  or outside the United States and its territories; and
  123         4. Distributed during the preceding year to entities that
  124  are not health care providers. Such information shall be
  125  aggregated by purchasers located within the United States and
  126  its territories or outside the United States and its
  127  territories.
  129  For purposes of this paragraph, the components that must be
  130  reported include whole blood, red blood cells, leukoreduced red
  131  blood cells, fresh frozen plasma or the equivalent, recovered
  132  plasma, platelets, and cryoprecipitated antihemophilic factor.
  133         (c) The blood establishment’s conflict-of-interest policy,
  134  policy concerning related-party transactions, whistleblower
  135  policy, and policy for determining executive compensation. If a
  136  change to any of these documents occurs, the revised document
  137  must be available on the blood establishment’s website by the
  138  following March 1.
  139         (d)1. The most recent 3 years of the Return of Organization
  140  Exempt from Income Tax, Internal Revenue Service Form 990, if
  141  the business entity for the blood establishment is eligible to
  142  file such return. The Form 990 must be available on the blood
  143  establishment’s website within 30 calendar days after it is
  144  filed with the Internal Revenue Service; or
  145         2. If the business entity for the blood establishment is
  146  not eligible to file the Form 990 return, a balance sheet,
  147  income statement, and statement of changes in cash flow, along
  148  with the expression of an opinion thereon by an independent
  149  certified public accountant who audited or reviewed such
  150  financial statements. Such documents must be available on the
  151  blood establishment’s website within 120 days after the end of
  152  the blood establishment’s fiscal year and must remain on the
  153  blood establishment’s website for at least 36 months.
  154         Section 2. Subsection (11) is added to section 483.201,
  155  Florida Statutes, to read:
  156         483.201 Grounds for disciplinary action against clinical
  157  laboratories.—In addition to the requirements of part II of
  158  chapter 408, the following acts constitute grounds for which a
  159  disciplinary action specified in s. 483.221 may be taken against
  160  a clinical laboratory:
  161         (11) For a blood establishment that collects blood or blood
  162  components from volunteer donors, failing to disclose
  163  information concerning its activities as required by s.
  164  381.06014. Each day of violation constitutes a separate
  165  violation and each separate violation is subject to a separate
  166  fine. If multiple licensed establishments operated by a single
  167  business entity fail to meet such disclosure requirements, the
  168  agency may assess fines against only one of the business
  169  entity’s clinical laboratory licenses. The total administrative
  170  fine may not exceed $10,000 for each annual reporting period.
  171         Section 3. Subsection (23) of section 499.003, Florida
  172  Statutes, is amended to read
  173         499.003 Definitions of terms used in this part.—As used in
  174  this part, the term:
  175         (23) “Health care entity” means a closed pharmacy or any
  176  person, organization, or business entity that provides
  177  diagnostic, medical, surgical, or dental treatment or care, or
  178  chronic or rehabilitative care, but does not include any
  179  wholesale distributor or retail pharmacy licensed under state
  180  law to deal in prescription drugs. However, a blood
  181  establishment may be a health care entity and engage in the
  182  wholesale distribution of prescription drugs under s.
  183  499.01(2)(g)1.c.
  184         Section 4. Subsection (21) of section 499.005, Florida
  185  Statutes, is amended to read:
  186         499.005 Prohibited acts.—It is unlawful for a person to
  187  perform or cause the performance of any of the following acts in
  188  this state:
  189         (21) The wholesale distribution of any prescription drug
  190  that was:
  191         (a) Purchased by a public or private hospital or other
  192  health care entity, except as authorized in s. 499.01(2)(g)1.c.;
  193  or
  194         (b) Donated or supplied at a reduced price to a charitable
  195  organization.
  196         Section 5. Paragraphs (a) and (g) of subsection (2) of
  197  section 499.01, Florida Statutes, are amended to read:
  198         499.01 Permits.—
  199         (2) The following permits are established:
  200         (a) Prescription drug manufacturer permit.—A prescription
  201  drug manufacturer permit is required for any person that is a
  202  manufacturer of a prescription drug and that manufactures or
  203  distributes such prescription drugs in this state.
  204         1. A person that operates an establishment permitted as a
  205  prescription drug manufacturer may engage in wholesale
  206  distribution of prescription drugs manufactured at that
  207  establishment and must comply with all of the provisions of this
  208  part, except s. 499.01212, and the rules adopted under this
  209  part, except s. 499.01212, which that apply to a wholesale
  210  distributor.
  211         2. A prescription drug manufacturer must comply with all
  212  appropriate state and federal good manufacturing practices.
  213         3. A blood establishment, as defined in s. 381.06014,
  214  operating in a manner consistent with the provisions of Title 21
  215  C.F.R. parts 211 and 600-640, and manufacturing only the
  216  prescription drugs described in s. 499.003(54)(d) is not
  217  required to be permitted as a prescription drug manufacturer
  218  under this paragraph or to register products under s. 499.015.
  219         (g) Restricted prescription drug distributor permit.—
  220         1. A restricted prescription drug distributor permit is
  221  required for:
  222         a. Any person that engages in the distribution of a
  223  prescription drug, which distribution is not considered
  224  “wholesale distribution” under s. 499.003(54)(a).
  225         b.1.Any A person who engages in the receipt or
  226  distribution of a prescription drug in this state for the
  227  purpose of processing its return or its destruction must obtain
  228  a permit as a restricted prescription drug distributor if such
  229  person is not the person initiating the return, the prescription
  230  drug wholesale supplier of the person initiating the return, or
  231  the manufacturer of the drug.
  232         c.A blood establishment located in this state which
  233  collects blood and blood components only from volunteer donors
  234  as defined in s. 381.06014 or pursuant to an authorized
  235  practitioner’s order for medical treatment or therapy and
  236  engages in the wholesale distribution of a prescription drug not
  237  described in s. 499.003(54)(d) to a health care entity. The
  238  health care entity receiving a prescription drug distributed
  239  under this sub-subparagraph must be licensed as a closed
  240  pharmacy or provide health care services at that establishment.
  241  The blood establishment must operate in accordance with s.
  242  381.06014 and may distribute only:
  243         (I) Prescription drugs indicated for a bleeding or clotting
  244  disorder or anemia;
  245         (II) Blood-collection containers approved under s. 505 of
  246  the federal act;
  247         (III) Drugs that are blood derivatives, or a recombinant or
  248  synthetic form of a blood derivative; or
  249         (IV) Prescription drugs that are identified in rules
  250  adopted by the department and that are essential to services
  251  performed or provided by blood establishments and authorized for
  252  distribution by blood establishments under federal law,
  254  as long as all of the health care services provided by the blood
  255  establishment are related to its activities as a registered
  256  blood establishment or the health care services consist of
  257  collecting, processing, storing, or administering human
  258  hematopoietic stem cells or progenitor cells or performing
  259  diagnostic testing of specimens if such specimens are tested
  260  together with specimens undergoing routine donor testing.
  261         2. Storage, handling, and recordkeeping of these
  262  distributions by a person permitted as a restricted prescription
  263  drug distributor must comply with the requirements for wholesale
  264  distributors under s. 499.0121, but not those set forth in s.
  265  499.01212 if the distribution occurs pursuant to sub
  266  subparagraph 1.a. or sub-subparagraph 1.b.
  267         3. A person who applies for a permit as a restricted
  268  prescription drug distributor, or for the renewal of such a
  269  permit, must provide to the department the information required
  270  under s. 499.012.
  271         4. The department may adopt rules regarding the
  272  distribution of prescription drugs by hospitals, health care
  273  entities, charitable organizations, or other persons not
  274  involved in wholesale distribution, and blood establishments;
  275  which rules are necessary for the protection of the public
  276  health, safety, and welfare. The department may adopt rules
  277  related to the transportation, storage, and recordkeeping of
  278  prescription drugs that are essential to services performed or
  279  provided by a blood establishment, including requirements for
  280  the use of prescription drugs in mobile blood-collection
  281  vehicles.
  282         Section 6. This act shall take effect July 1, 2011.