Florida Senate - 2011                               CS for SB 94
       By the Committee on Health Regulation; and Senator Gaetz
       588-00653-11                                            201194c1
    1                        A bill to be entitled                      
    2         An act relating to blood establishments; amending s.
    3         381.06014, F.S.; redefining the term “blood
    4         establishment” and defining the term “volunteer
    5         donor”; prohibiting local governments from restricting
    6         access to public facilities or infrastructure for
    7         certain activities based on whether a blood
    8         establishment is operating as a for-profit
    9         organization or not-for-profit organization;
   10         prohibiting a blood establishment from considering
   11         whether certain customers are operating as for-profit
   12         organizations or not-for-profit organizations when
   13         determining service fees for selling blood or blood
   14         components; requiring that certain blood
   15         establishments disclose specified information on the
   16         Internet; authorizing the Department of Legal Affairs
   17         to assess a civil penalty against a blood
   18         establishment that fails to disclose specified
   19         information on the Internet; providing that the civil
   20         penalty accrues to the state and requiring that it be
   21         deposited as received into the General Revenue Fund;
   22         amending s. 499.003, F.S.; redefining the term “health
   23         care entity” to clarify that a blood establishment is
   24         a health care entity that may engage in certain
   25         activities; amending s. 499.005, F.S.; clarifying
   26         provisions that prohibit the unauthorized wholesale
   27         distribution of a prescription drug that was purchased
   28         by a hospital or other health care entity or donated
   29         or supplied at a reduced price to a charitable
   30         organization, to conform to changes made by the act;
   31         amending s. 499.01, F.S.; exempting certain blood
   32         establishments from the requirements to be permitted
   33         as a prescription drug manufacturer and register
   34         products; requiring that certain blood establishments
   35         obtain a restricted prescription drug distributor
   36         permit under specified conditions; limiting the
   37         prescription drugs that a blood establishment may
   38         distribute under a restricted prescription drug
   39         distributor permit; authorizing the Department of
   40         Health to adopt rules regarding the distribution of
   41         prescription drugs by blood establishments; providing
   42         an effective date.
   44  Be It Enacted by the Legislature of the State of Florida:
   46         Section 1. Section 381.06014, Florida Statutes, is amended
   47  to read:
   48         381.06014 Blood establishments.—
   49         (1) As used in this section, the term:
   50         (a) “Blood establishment” means any person, entity, or
   51  organization, operating within the state, which examines an
   52  individual for the purpose of blood donation or which collects,
   53  processes, stores, tests, or distributes blood or blood
   54  components collected from the human body for the purpose of
   55  transfusion, for any other medical purpose, or for the
   56  production of any biological product. A person, entity, or
   57  organization that uses a mobile unit to conduct such activities
   58  within the state is also a blood establishment.
   59         (b) “Volunteer donor” means a person who does not receive
   60  remuneration, other than an incentive, for a blood donation
   61  intended for transfusion, and the product container of the
   62  donation from the person qualifies for labeling with the
   63  statement “volunteer donor” under 21 C.F.R. s. 606.121.
   64         (2) Any blood establishment operating in the state may not
   65  conduct any activity defined in paragraph (1)(a) subsection (1)
   66  unless that blood establishment is operated in a manner
   67  consistent with the provisions of Title 21 C.F.R. parts 211 and
   68  600-640, Code of Federal Regulations.
   69         (3) Any blood establishment determined to be operating in
   70  the state in a manner not consistent with the provisions of
   71  Title 21 C.F.R. parts 211 and 600-640, Code of Federal
   72  Regulations, and in a manner that constitutes a danger to the
   73  health or well-being of donors or recipients as evidenced by the
   74  federal Food and Drug Administration’s inspection reports and
   75  the revocation of the blood establishment’s license or
   76  registration is shall be in violation of this chapter and must
   77  shall immediately cease all operations in the state.
   78         (4) The operation of a blood establishment in a manner not
   79  consistent with the provisions of Title 21 C.F.R. parts 211 and
   80  600-640, Code of Federal Regulations, and in a manner that
   81  constitutes a danger to the health or well-being of blood donors
   82  or recipients as evidenced by the federal Food and Drug
   83  Administration’s inspection process is declared a nuisance and
   84  inimical to the public health, welfare, and safety. The Agency
   85  for Health Care Administration or any state attorney may bring
   86  an action for an injunction to restrain such operations or
   87  enjoin the future operation of the blood establishment.
   88         (5) A local government may not restrict the access to or
   89  use of any public facility or infrastructure for the collection
   90  of blood or blood components from volunteer donors based on
   91  whether the blood establishment is operating as a for-profit
   92  organization or not-for-profit organization.
   93         (6) In determining the service fee of blood or blood
   94  components received from volunteer donors and sold to hospitals
   95  or other health care providers, a blood establishment may not
   96  base the service fee of the blood or blood component solely on
   97  whether the purchasing entity is a for-profit organization or
   98  not-for-profit organization.
   99         (7) A blood establishment that collects blood or blood
  100  components from volunteer donors must disclose on the Internet
  101  the information required under this subsection to educate and
  102  inform donors and the public about the blood establishment’s
  103  activities. A hospital that collects blood or blood components
  104  to be used only by that hospital’s licensed facilities or by a
  105  health care provider that is a part of the hospital’s business
  106  entity is exempt from the disclosure requirements in this
  107  subsection. The information required to be disclosed under this
  108  subsection may be cumulative for all blood establishments within
  109  a business entity. A blood establishment must disclose on its
  110  website all of the following information:
  111         (a) A description of the steps involved in collecting,
  112  processing, and distributing volunteer donations.
  113         (b) By March 1 of each year, the number of units of blood
  114  components which were:
  115         1. Produced by the blood establishment during the preceding
  116  calendar year;
  117         2. Obtained from other sources during the preceding
  118  calendar year;
  119         3. Distributed during the preceding calendar year to health
  120  care providers located outside this state. However, if the blood
  121  establishment collects donations in a county outside this state,
  122  distributions to health care providers in that county shall be
  123  excluded. Such information shall be reported in the aggregate
  124  for health care providers located within the United States and
  125  its territories or outside the United States and its
  126  territories; and
  127         4. Distributed during the preceding calendar year to
  128  entities that are not health care providers. Such information
  129  shall be reported in the aggregate for purchasers located within
  130  the United States and its territories or outside the United
  131  States and its territories.
  132         (c) The blood establishment’s conflict-of-interest policy,
  133  policy concerning related-party transactions, whistleblower
  134  policy, and policy for determining executive compensation. If a
  135  change occurs to any of these documents, the revised document
  136  must be available on the blood establishment’s website by the
  137  following March 1.
  138         (d) Except for a hospital that collects blood or blood
  139  components from volunteer donors:
  140         1. The most recent 3 years of the Return of Organization
  141  Exempt from Income Tax, Internal Revenue Service Form 990, if
  142  the business entity for the blood establishment is eligible to
  143  file such return. The Form 990 must be available on the blood
  144  establishment’s website within 60 calendar days after it is
  145  filed with the Internal Revenue Service; or
  146         2. If the business entity for the blood establishment is
  147  not eligible to file the Form 990 return, a balance sheet,
  148  income statement, and statement of changes in cash flow, along
  149  with the expression of an opinion thereon by an independent
  150  certified public accountant who audited or reviewed such
  151  financial statements. Such documents must be available on the
  152  blood establishment’s website within 120 days after the end of
  153  the blood establishment’s fiscal year and must remain on the
  154  blood establishment’s website for at least 36 months.
  155         (8) A blood establishment is liable for a civil penalty for
  156  failing to make the disclosures required under subsection (7).
  157  The Department of Legal Affairs may assess the civil penalty
  158  against the blood establishment for each day that it fails to
  159  make such required disclosures, but the penalty may not exceed
  160  $10,000 per year. If multiple blood establishments operated by a
  161  single business entity fail to meet such disclosure
  162  requirements, the civil penalty may be assessed against only one
  163  of the business entity’s blood establishments. The Department of
  164  Legal Affairs may terminate an action if the blood establishment
  165  agrees to pay a stipulated civil penalty. A civil penalty so
  166  collected accrues to the state and shall be deposited as
  167  received into the General Revenue Fund unallocated. The
  168  Department of Legal Affairs may terminate the action and waive
  169  the civil penalty upon a showing of good cause by the blood
  170  establishment as to why the required disclosures were not made.
  171         Section 2. 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 is a health care entity that may engage in the
  182  wholesale distribution of prescription drugs under s.
  183  499.01(2)(g)1.c.
  184         Section 3. 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; or
  193         (b) Donated or supplied at a reduced price to a charitable
  194  organization,
  196  unless the wholesale distribution of the prescription drug is
  197  authorized in s. 499.01(2)(g)1.c.
  198         Section 4. Paragraphs (a) and (g) of subsection (2) of
  199  section 499.01, Florida Statutes, are amended to read:
  200         499.01 Permits.—
  201         (2) The following permits are established:
  202         (a) Prescription drug manufacturer permit.—A prescription
  203  drug manufacturer permit is required for any person that is a
  204  manufacturer of a prescription drug and that manufactures or
  205  distributes such prescription drugs in this state.
  206         1. A person that operates an establishment permitted as a
  207  prescription drug manufacturer may engage in wholesale
  208  distribution of prescription drugs manufactured at that
  209  establishment and must comply with all of the provisions of this
  210  part, except s. 499.01212, and the rules adopted under this
  211  part, except s. 499.01212, which that apply to a wholesale
  212  distributor.
  213         2. A prescription drug manufacturer must comply with all
  214  appropriate state and federal good manufacturing practices.
  215         3. A blood establishment, as defined in s. 381.06014,
  216  operating in a manner consistent with the provisions of Title 21
  217  C.F.R. parts 211 and 600-640, and manufacturing only the
  218  prescription drugs described in s. 499.003(54)(d) is not
  219  required to be permitted as a prescription drug manufacturer
  220  under this paragraph or to register products under s. 499.015.
  221         (g) Restricted prescription drug distributor permit.—
  222         1. A restricted prescription drug distributor permit is
  223  required for:
  224         a. Any person located in this state that engages in the
  225  distribution of a prescription drug, which distribution is not
  226  considered “wholesale distribution” under s. 499.003(54)(a).
  227         b.1.Any A person located in this state who engages in the
  228  receipt or distribution of a prescription drug in this state for
  229  the purpose of processing its return or its destruction must
  230  obtain a permit as a restricted prescription drug distributor if
  231  such person is not the person initiating the return, the
  232  prescription drug wholesale supplier of the person initiating
  233  the return, or the manufacturer of the drug.
  234         c.A blood establishment located in this state which
  235  collects blood and blood components only from volunteer donors
  236  as defined in s. 381.06014 or pursuant to an authorized
  237  practitioner’s order for medical treatment or therapy and
  238  engages in the wholesale distribution of a prescription drug not
  239  described in s. 499.003(54)(d) to a health care entity. The
  240  health care entity receiving a prescription drug distributed
  241  under this sub-subparagraph must be licensed as a closed
  242  pharmacy or provide health care services at that establishment.
  243  The blood establishment must operate in accordance with s.
  244  381.06014 and may distribute only:
  245         (I) Prescription drugs indicated for a bleeding or clotting
  246  disorder or anemia;
  247         (II) Blood-collection containers approved under s. 505 of
  248  the federal act;
  249         (III) Drugs that are blood derivatives, or a recombinant or
  250  synthetic form of a blood derivative;
  251         (IV) Prescription drugs that are identified in rules
  252  adopted by the department and that are essential to services
  253  performed or provided by blood establishments and authorized for
  254  distribution by blood establishments under federal law; or
  255         (V) To the extent authorized by federal law, drugs
  256  necessary to collect blood or blood components from volunteer
  257  blood donors; for blood establishment personnel to perform
  258  therapeutic procedures under the direction and supervision of a
  259  licensed physician; and to diagnose, treat, manage, and prevent
  260  any reaction of either a volunteer blood donor or a patient
  261  undergoing a therapeutic procedure performed under the direction
  262  and supervision of a licensed physician,
  264  as long as all of the health care services provided by the blood
  265  establishment are related to its activities as a registered
  266  blood establishment or the health care services consist of
  267  collecting, processing, storing, or administering human
  268  hematopoietic stem cells or progenitor cells or performing
  269  diagnostic testing of specimens if such specimens are tested
  270  together with specimens undergoing routine donor testing.
  271         2. Storage, handling, and recordkeeping of these
  272  distributions by a person required to be permitted as a
  273  restricted prescription drug distributor must comply with the
  274  requirements for wholesale distributors under s. 499.0121, but
  275  not those set forth in s. 499.01212 if the distribution occurs
  276  pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
  277         3. A person who applies for a permit as a restricted
  278  prescription drug distributor, or for the renewal of such a
  279  permit, must provide to the department the information required
  280  under s. 499.012.
  281         4. The department may adopt rules regarding the
  282  distribution of prescription drugs by hospitals, health care
  283  entities, charitable organizations, or other persons not
  284  involved in wholesale distribution, and blood establishments,
  285  which rules are necessary for the protection of the public
  286  health, safety, and welfare.
  287         Section 5. This act shall take effect July 1, 2011.