Florida Senate - 2011                        COMMITTEE AMENDMENT
       Bill No. SB 1736
       
       
       
       
       
       
                                Barcode 446694                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/22/2011           .                                
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       The Committee on Health Regulation (Gaetz) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 3310 and 3311
    4  insert:
    5         Section 88. Section 381.06014, Florida Statutes, is amended
    6  to read:
    7         381.06014 Blood establishments.—
    8         (1) As used in this section, the term:
    9         (a) “Blood establishment” means any person, entity, or
   10  organization, operating within the state, which examines an
   11  individual for the purpose of blood donation or which collects,
   12  processes, stores, tests, or distributes blood or blood
   13  components collected from the human body for the purpose of
   14  transfusion, for any other medical purpose, or for the
   15  production of any biological product. A person, entity, or
   16  organization that uses a mobile unit to conduct such activities
   17  within the state is also a blood establishment.
   18         (b) “Volunteer donor” means a person who does not receive
   19  remuneration, other than an incentive, for a blood donation
   20  intended for transfusion, and the product container of the
   21  donation from the person qualifies for labeling with the
   22  statement “volunteer donor” under 21 C.F.R. s. 606.121.
   23         (2) Any blood establishment operating in the state may not
   24  conduct any activity defined in paragraph (1)(a) subsection (1)
   25  unless that blood establishment is operated in a manner
   26  consistent with the provisions of Title 21 C.F.R. parts 211 and
   27  600-640, Code of Federal Regulations.
   28         (3) Any blood establishment determined to be operating in
   29  the state in a manner not consistent with the provisions of
   30  Title 21 C.F.R. parts 211 and 600-640, Code of Federal
   31  Regulations, and in a manner that constitutes a danger to the
   32  health or well-being of donors or recipients as evidenced by the
   33  federal Food and Drug Administration’s inspection reports and
   34  the revocation of the blood establishment’s license or
   35  registration is shall be in violation of this chapter and must
   36  shall immediately cease all operations in the state.
   37         (4) The operation of a blood establishment in a manner not
   38  consistent with the provisions of Title 21 C.F.R. parts 211 and
   39  600-640, Code of Federal Regulations, and in a manner that
   40  constitutes a danger to the health or well-being of blood donors
   41  or recipients as evidenced by the federal Food and Drug
   42  Administration’s inspection process is declared a nuisance and
   43  inimical to the public health, welfare, and safety. The Agency
   44  for Health Care Administration or any state attorney may bring
   45  an action for an injunction to restrain such operations or
   46  enjoin the future operation of the blood establishment.
   47         (5) A local government may not restrict the access to or
   48  use of any public facility or infrastructure for the collection
   49  of blood or blood components from volunteer donors based on
   50  whether the blood establishment is operating as a for-profit
   51  organization or not-for-profit organization.
   52         (6) In determining the service fee of blood or blood
   53  components received from volunteer donors and sold to hospitals
   54  or other health care providers, a blood establishment may not
   55  base the service fee of the blood or blood component solely on
   56  whether the purchasing entity is a for-profit organization or
   57  not-for-profit organization.
   58         (7) A blood establishment that collects blood or blood
   59  components from volunteer donors must disclose on the Internet
   60  the information required under this subsection to educate and
   61  inform donors and the public about the blood establishment’s
   62  activities. A hospital that collects blood or blood components
   63  to be used only by that hospital’s licensed facilities or by a
   64  health care provider that is a part of the hospital’s business
   65  entity is exempt from the disclosure requirements in this
   66  subsection. The information required to be disclosed under this
   67  subsection may be cumulative for all blood establishments within
   68  a business entity. A blood establishment must disclose on its
   69  website all of the following information:
   70         (a) A description of the steps involved in collecting,
   71  processing, and distributing volunteer donations.
   72         (b) By March 1 of each year, the number of units of blood
   73  components which were:
   74         1. Produced by the blood establishment during the preceding
   75  calendar year;
   76         2. Obtained from other sources during the preceding
   77  calendar year;
   78         3. Distributed during the preceding calendar year to health
   79  care providers located outside this state. However, if the blood
   80  establishment collects donations in a county outside this state,
   81  distributions to health care providers in that county shall be
   82  excluded. Such information shall be reported in the aggregate
   83  for health care providers located within the United States and
   84  its territories or outside the United States and its
   85  territories; and
   86         4. Distributed during the preceding calendar year to
   87  entities that are not health care providers. Such information
   88  shall be reported in the aggregate for purchasers located within
   89  the United States and its territories or outside the United
   90  States and its territories.
   91         (c) The blood establishment’s conflict-of-interest policy,
   92  policy concerning related-party transactions, whistleblower
   93  policy, and policy for determining executive compensation. If a
   94  change occurs to any of these documents, the revised document
   95  must be available on the blood establishment’s website by the
   96  following March 1.
   97         (d) Except for a hospital that collects blood or blood
   98  components from volunteer donors:
   99         1. The most recent 3 years of the Return of Organization
  100  Exempt from Income Tax, Internal Revenue Service Form 990, if
  101  the business entity for the blood establishment is eligible to
  102  file such return. The Form 990 must be available on the blood
  103  establishment’s website within 60 calendar days after it is
  104  filed with the Internal Revenue Service; or
  105         2. If the business entity for the blood establishment is
  106  not eligible to file the Form 990 return, a balance sheet,
  107  income statement, and statement of changes in cash flow, along
  108  with the expression of an opinion thereon by an independent
  109  certified public accountant who audited or reviewed such
  110  financial statements. Such documents must be available on the
  111  blood establishment’s website within 120 days after the end of
  112  the blood establishment’s fiscal year and must remain on the
  113  blood establishment’s website for at least 36 months.
  114         (8) A blood establishment is liable for a civil penalty for
  115  failing to make the disclosures required under subsection (7).
  116  The Department of Legal Affairs may assess the civil penalty
  117  against the blood establishment for each day that it fails to
  118  make such required disclosures, but the penalty may not exceed
  119  $10,000 per year. If multiple blood establishments operated by a
  120  single business entity fail to meet such disclosure
  121  requirements, the civil penalty may be assessed against only one
  122  of the business entity’s blood establishments. The Department of
  123  Legal Affairs may terminate an action if the blood establishment
  124  agrees to pay a stipulated civil penalty. A civil penalty so
  125  collected accrues to the state and shall be deposited as
  126  received into the General Revenue Fund unallocated. The
  127  Department of Legal Affairs may terminate the action and waive
  128  the civil penalty upon a showing of good cause by the blood
  129  establishment as to why the required disclosures were not made.
  130         Section 89. Subsection (23) of section 499.003, Florida
  131  Statutes, is amended to read:
  132         499.003 Definitions of terms used in this part.—As used in
  133  this part, the term:
  134         (23) “Health care entity” means a closed pharmacy or any
  135  person, organization, or business entity that provides
  136  diagnostic, medical, surgical, or dental treatment or care, or
  137  chronic or rehabilitative care, but does not include any
  138  wholesale distributor or retail pharmacy licensed under state
  139  law to deal in prescription drugs. However, a blood
  140  establishment is a health care entity that may engage in the
  141  wholesale distribution of prescription drugs under s.
  142  499.01(2)(g)1.c.
  143         Section 90. Subsection (21) of section 499.005, Florida
  144  Statutes, is amended to read:
  145         499.005 Prohibited acts.—It is unlawful for a person to
  146  perform or cause the performance of any of the following acts in
  147  this state:
  148         (21) The wholesale distribution of any prescription drug
  149  that was:
  150         (a) Purchased by a public or private hospital or other
  151  health care entity; or
  152         (b) Donated or supplied at a reduced price to a charitable
  153  organization,
  154  
  155  unless the wholesale distribution of the prescription drug is
  156  authorized in s. 499.01(2)(g)1.c.
  157         Section 91. Paragraphs (a) and (g) of subsection (2) of
  158  section 499.01, Florida Statutes, are amended to read:
  159         499.01 Permits.—
  160         (2) The following permits are established:
  161         (a) Prescription drug manufacturer permit.—A prescription
  162  drug manufacturer permit is required for any person that is a
  163  manufacturer of a prescription drug and that manufactures or
  164  distributes such prescription drugs in this state.
  165         1. A person that operates an establishment permitted as a
  166  prescription drug manufacturer may engage in wholesale
  167  distribution of prescription drugs manufactured at that
  168  establishment and must comply with all of the provisions of this
  169  part, except s. 499.01212, and the rules adopted under this
  170  part, except s. 499.01212, which that apply to a wholesale
  171  distributor.
  172         2. A prescription drug manufacturer must comply with all
  173  appropriate state and federal good manufacturing practices.
  174         3. A blood establishment, as defined in s. 381.06014,
  175  operating in a manner consistent with the provisions of Title 21
  176  C.F.R. parts 211 and 600-640, and manufacturing only the
  177  prescription drugs described in s. 499.003(54)(d) is not
  178  required to be permitted as a prescription drug manufacturer
  179  under this paragraph or to register products under s. 499.015.
  180         (g) Restricted prescription drug distributor permit.—
  181         1. A restricted prescription drug distributor permit is
  182  required for:
  183         a. Any person located in this state that engages in the
  184  distribution of a prescription drug, which distribution is not
  185  considered “wholesale distribution” under s. 499.003(54)(a).
  186         b.1.Any A person located in this state who engages in the
  187  receipt or distribution of a prescription drug in this state for
  188  the purpose of processing its return or its destruction must
  189  obtain a permit as a restricted prescription drug distributor if
  190  such person is not the person initiating the return, the
  191  prescription drug wholesale supplier of the person initiating
  192  the return, or the manufacturer of the drug.
  193         c.A blood establishment located in this state which
  194  collects blood and blood components only from volunteer donors
  195  as defined in s. 381.06014 or pursuant to an authorized
  196  practitioner’s order for medical treatment or therapy and
  197  engages in the wholesale distribution of a prescription drug not
  198  described in s. 499.003(54)(d) to a health care entity. The
  199  health care entity receiving a prescription drug distributed
  200  under this sub-subparagraph must be licensed as a closed
  201  pharmacy or provide health care services at that establishment.
  202  The blood establishment must operate in accordance with s.
  203  381.06014 and may distribute only:
  204         (I) Prescription drugs indicated for a bleeding or clotting
  205  disorder or anemia;
  206         (II) Blood-collection containers approved under s. 505 of
  207  the federal act;
  208         (III) Drugs that are blood derivatives, or a recombinant or
  209  synthetic form of a blood derivative;
  210         (IV) Prescription drugs that are identified in rules
  211  adopted by the department and that are essential to services
  212  performed or provided by blood establishments and authorized for
  213  distribution by blood establishments under federal law; or
  214         (V) To the extent authorized by federal law, drugs
  215  necessary to collect blood or blood components from volunteer
  216  blood donors; for blood establishment personnel to perform
  217  therapeutic procedures under the direction and supervision of a
  218  licensed physician; and to diagnose, treat, manage, and prevent
  219  any reaction of either a volunteer blood donor or a patient
  220  undergoing a therapeutic procedure performed under the direction
  221  and supervision of a licensed physician,
  222  
  223  as long as all of the health care services provided by the blood
  224  establishment are related to its activities as a registered
  225  blood establishment or the health care services consist of
  226  collecting, processing, storing, or administering human
  227  hematopoietic stem cells or progenitor cells or performing
  228  diagnostic testing of specimens if such specimens are tested
  229  together with specimens undergoing routine donor testing.
  230         2. Storage, handling, and recordkeeping of these
  231  distributions by a person required to be permitted as a
  232  restricted prescription drug distributor must comply with the
  233  requirements for wholesale distributors under s. 499.0121, but
  234  not those set forth in s. 499.01212 if the distribution occurs
  235  pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
  236         3. A person who applies for a permit as a restricted
  237  prescription drug distributor, or for the renewal of such a
  238  permit, must provide to the department the information required
  239  under s. 499.012.
  240         4. The department may adopt rules regarding the
  241  distribution of prescription drugs by hospitals, health care
  242  entities, charitable organizations, or other persons not
  243  involved in wholesale distribution, and blood establishments,
  244  which rules are necessary for the protection of the public
  245  health, safety, and welfare.
  246  
  247  ================= T I T L E  A M E N D M E N T ================
  248         And the title is amended as follows:
  249         Delete lines 263 - 264
  250  and insert:
  251         by the act; revising a reference; amending s.
  252         381.06014, F.S.; redefining the term “blood
  253         establishment” and defining the term “volunteer
  254         donor”; prohibiting local governments from restricting
  255         access to public facilities or infrastructure for
  256         certain activities based on whether a blood
  257         establishment is operating as a for-profit
  258         organization or not-for-profit organization;
  259         prohibiting a blood establishment from considering
  260         whether certain customers are operating as for-profit
  261         organizations or not-for-profit organizations when
  262         determining service fees for selling blood or blood
  263         components; requiring that certain blood
  264         establishments disclose specified information on the
  265         Internet; authorizing the Department of Legal Affairs
  266         to assess a civil penalty against a blood
  267         establishment that fails to disclose specified
  268         information on the Internet; providing that the civil
  269         penalty accrues to the state and requiring that it be
  270         deposited as received into the General Revenue Fund;
  271         amending s. 499.003, F.S.; redefining the term “health
  272         care entity” to clarify that a blood establishment is
  273         a health care entity that may engage in certain
  274         activities; amending s. 499.005, F.S.; clarifying
  275         provisions that prohibit the unauthorized wholesale
  276         distribution of a prescription drug that was purchased
  277         by a hospital or other health care entity or donated
  278         or supplied at a reduced price to a charitable
  279         organization, to conform to changes made by the act;
  280         amending s. 499.01, F.S.; exempting certain blood
  281         establishments from the requirements to be permitted
  282         as a prescription drug manufacturer and register
  283         products; requiring that certain blood establishments
  284         obtain a restricted prescription drug distributor
  285         permit under specified conditions; limiting the
  286         prescription drugs that a blood establishment may
  287         distribute under a restricted prescription drug
  288         distributor permit; authorizing the Department of
  289         Health to adopt rules regarding the distribution of
  290         prescription drugs by blood establishments; providing
  291         an effective date.