Florida Senate - 2011                        COMMITTEE AMENDMENT
       Bill No. SB 94
                                Barcode 264066                          
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  01/11/2011           .                                

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