Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. SB 512
       
       
       
       
       
       
                                Ì846704+Î846704                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  02/04/2020           .                                
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       The Committee on Health Policy (Hutson) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 381.06017, Florida Statutes, is created
    6  to read:
    7         381.06017 Nonembryonic stem cell banks; collection,
    8  manufacturing, storage, dispensing, and use of human
    9  nonembryonic stem cells.—
   10         (1) DEFINITIONS.—As used in this section, the term:
   11         (a)“Compounding means combining, mixing, or altering the
   12  ingredients of one or more drugs or products to create another
   13  drug or product.
   14         (b)“Dispense” has the same meaning as in s. 465.003(6).
   15         (c)“Establishment” means a place of business which is at
   16  one general physical location and may extend to one or more
   17  contiguous suites, units, floors, or buildings operated and
   18  controlled exclusively by entities under common operation and
   19  control. The term includes multiple buildings with an
   20  intervening thoroughfare if the buildings are under common
   21  exclusive ownership, operation, and control. For purposes of
   22  permitting, each suite, unit, floor, or building must be
   23  identified in the most recent permit application.
   24         (d)“Federal act” means the Federal Food, Drug, and
   25  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
   26         (e)“Minimally manipulated” means:
   27         1.For structural tissue, processing that does not alter
   28  the original characteristics of the tissue which relate to the
   29  tissue’s utility for reconstruction, repair, or replacement; or
   30         2.For cells or nonstructural tissue, processing that does
   31  not alter the relevant biological characteristics of the cell or
   32  tissue.
   33         (f)“Nonembryonic stem cell,” also referred to as a
   34  “somatic stem cell” or an “adult human stem cell,” means an
   35  allogenic or autologous cell that is undifferentiated and
   36  unspecialized and that has the ability to divide for indefinite
   37  periods of time in a medium and to become a specialized cell.
   38  The term includes a human nonembryonic cell that is altered or
   39  processed to become undifferentiated, losing its original
   40  structural function, so that it can be differentiated into a
   41  specialized cell type. The term does not include cells that are
   42  minimally manipulated or are only rinsed, cleaned, or sized and
   43  remain differentiated.
   44         (g)Nonembryonic stem cell bank” means a publicly or
   45  privately owned establishment that does any of the following:
   46         1.Collects and stores human nonembryonic stem cells for
   47  use in a product or patient-specific medical administration.
   48         2.Provides patient-specific health care services using
   49  human nonembryonic stem cells.
   50         3.Advertises human nonembryonic stem cell services,
   51  including, but not limited to, collection, manufacturing,
   52  storage, dispensing, use, or purported use of human nonembryonic
   53  stem cells or products containing human nonembryonic stem cells,
   54  which have not been approved by the United States Food and Drug
   55  Administration or are not the subject of clinical trials
   56  approved by the United States Food and Drug Administration and
   57  which are intended to diagnose, cure, mitigate, treat, provide
   58  therapy for, or prevent an injury or a disease.
   59         4. Performs any procedure that is intended to:
   60         a.Collect or store human nonembryonic stem cells for any
   61  purpose; or
   62         b.Diagnose, cure, mitigate, treat, provide therapy for, or
   63  prevent an injury or a disease with the use or purported use of
   64  human nonembryonic stem cells or any product containing human
   65  nonembryonic stem cells which has not been approved by the
   66  United States Food and Drug Administration or is not the subject
   67  of a clinical trial approved by the United States Food and Drug
   68  Administration.
   69         5.Compounds human nonembryonic stem cells from human
   70  nonembryonic cells or tissue into products by combining, mixing,
   71  or altering the ingredients of one or more drugs or products to
   72  create another drug or product.
   73         6.Manufactures, through recovery, processing,
   74  manipulation, enzymatic digestion, mechanical disruption, or a
   75  similar process, human nonembryonic stem cells from human
   76  nonembryonic cells or tissue into undifferentiated human
   77  nonembryonic stem cells, causing the cells to lose their
   78  original structural function so that the nonembryonic stem cells
   79  may be differentiated into specialized cell types.
   80         7.Dispenses human nonembryonic stem cells and products
   81  containing nonembryonic stem cells to any of the following for a
   82  specific patient pursuant to a valid prescription from a
   83  licensed health care practitioner authorized within the scope of
   84  his or her license to prescribe and administer human
   85  nonembryonic stem cells:
   86         a.A pharmacy permitted under chapter 465.
   87         b.A health care practitioner with privileges to practice
   88  at nonembryonic stem cell banks.
   89         c.A health care practitioner’s office, a health care
   90  facility, or a treatment setting where the health care
   91  practitioner has privileges to practice, for office use.
   92         (h)Office use” means the provision and administration of
   93  a drug, compounded drug, or compounded product to a patient by a
   94  health care practitioner in the practitioner’s office or in a
   95  health care facility or treatment setting, including a hospital,
   96  ambulatory surgery center, or health care clinic licensed under
   97  chapter 395 or chapter 400. The term also includes the
   98  dispensing by a pharmacist at a nonembryonic stem cell bank that
   99  is also permitted as a pharmacy under chapter 465 to a
  100  nonembryonic stem cell bank within this state of any of the
  101  following:
  102         1.Human nonembryonic stem cells.
  103         2.A compounded drug containing human nonembryonic stem
  104  cells.
  105         3.A compounded product containing nonembryonic stem cells.
  106         (2) DUTIES AND REGISTRATION.—A nonembryonic stem cell bank
  107  that advertises, collects, stores, manufactures, dispenses,
  108  compounds, uses, or purports to use nonembryonic stem cells or
  109  products containing nonembryonic stem cells is deemed a clinic
  110  as defined in s. 400.9905 and must comply with all of the
  111  following requirements:
  112         (a)Adhere to the applicable current good manufacturing
  113  practices for the collection, removal, manufacturing,
  114  processing, compounding, and implantation of nonembryonic stem
  115  cells or products containing nonembryonic stem cells pursuant to
  116  the federal act and 21 C.F.R., parts 1270-1271.
  117         (b)Obtain a health care clinic license from the agency
  118  pursuant to s. 400.991 and part II of chapter 408 and register
  119  each establishment separately, unless:
  120         1. The clinic is a facility licensed under chapter 395; or
  121         2. The clinic is affiliated with an accredited medical
  122  school that provides training to medical students, residents, or
  123  fellows.
  124         (c)Have a physician medical director who is responsible
  125  for complying with all requirements related to licensure,
  126  operation of a nonembryonic stem cell bank, and good
  127  manufacturing practices under this section, part X of chapter
  128  400, and the federal act and 21 C.F.R., parts 1270-1271.
  129         (d)Notify the agency in writing on a form approved by the
  130  agency within 10 days after termination of a physician medical
  131  director and notify the agency within 10 days after such
  132  termination of the identity of the physician medical director
  133  who has assumed responsibility for that nonembryonic stem cell
  134  bank. Failure to have a physician medical director practicing at
  135  the location of the licensed nonembryonic stem cell bank shall
  136  be the basis for a summary suspension of the nonembryonic stem
  137  cell bank’s license pursuant to s. 400.607 or s. 120.60(6).
  138         (e)Require a physician medical director to have a full,
  139  active, and unencumbered license issued under chapter 458 or
  140  chapter 459 and to actively practice at the nonembryonic stem
  141  cell bank location for which he or she has assumed
  142  responsibility.
  143         (f)Maintain commercial and professional liability
  144  insurance in an amount not less than $250,000 per claim.
  145         (g)Operate each establishment using the same name as the
  146  one used to obtain the health care clinic license from the
  147  agency. All invoices, packing slips, and other business records
  148  must list the same name.
  149         (h)Obtain a pharmacy permit for each person and
  150  establishment before dispensing, offering office use for the
  151  compounding of human nonembryonic stem cells, or dispensing a
  152  compounded product for office use.
  153         (i)Pay all costs associated with licensure, registration,
  154  and inspection.
  155         (3)DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
  156         (a)A pharmacist at a nonembryonic stem cell bank that is
  157  also permitted as a pharmacy under chapter 465 may dispense any
  158  of the following to a stem cell bank within the state, for
  159  office use:
  160         1.Human nonembryonic stem cells;
  161         2.A compounded drug containing human nonembryonic stem
  162  cells; or
  163         3.A compounded product containing human nonembryonic stem
  164  cells.
  165         (b)Human nonembryonic stem cells, compounded drugs
  166  containing human nonembryonic stem cells, or products containing
  167  human nonembryonic stem cells may not be sold or dispensed by
  168  any person or establishment other than the nonembryonic stem
  169  cell bank or pharmacist at the nonembryonic stem cell bank that
  170  manufactured the human nonembryonic stem cells or the compounded
  171  drug or product containing human nonembryonic stem cells, except
  172  that:
  173         1.A health care practitioner who requests the dispensing
  174  of the human nonembryonic stem cells, compounded drug, or
  175  compounded product from the manufacturing nonembryonic stem cell
  176  bank may sell or dispense such items to his or her patient if
  177  the health care practitioner is authorized within the scope of
  178  his or her license to prescribe and administer human
  179  nonembryonic stem cells; or
  180         2.A pharmacist, pharmacy, or establishment that requests
  181  the dispensing of the human nonembryonic stem cells, compounded
  182  drug, or compounded product from the manufacturing nonembryonic
  183  stem cell bank may sell or dispense such items to a health care
  184  practitioner who is authorized within the scope of his or her
  185  license to prescribe and administer human nonembryonic stem
  186  cells to patients.
  187         (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
  188         (a) A physician licensed under chapter 458 or chapter 459,
  189  an advanced practice registered nurse licensed under chapter
  190  464, or a physician assistant licensed under chapter 458 or
  191  chapter 459 may not practice in a nonembryonic stem cell bank
  192  that is not licensed with the agency as required by the rules
  193  adopted pursuant to s. 400.9925. The license of a health care
  194  practitioner who violates this paragraph is subject to
  195  disciplinary action by the appropriate regulatory board.
  196         (b) In the performance of any procedure collecting,
  197  storing, using, or purporting to use nonembryonic stem cells or
  198  products containing nonembryonic stem cells, a health care
  199  practitioner must adhere to the applicable current good
  200  manufacturing practices for the collection, removal,
  201  manufacturing, processing, compounding, and implantation of stem
  202  cells or products containing stem cells pursuant to the federal
  203  act and 21 C.F.R., parts 1270-1271.
  204         (5) RULEMAKING.—The agency shall adopt rules necessary to
  205  administer the licensure and regulation of nonembryonic stem
  206  cell banks, including, but not limited to, rules regarding all
  207  of the following, which must be consistent with the best
  208  practices specified in the federal act and 21 C.F.R., parts
  209  1270-1271:
  210         (a)Advertising.
  211         (b)Nonembryonic stem cell bank procedures and protocols
  212  for the collection, manufacturing, storing, dispensing, and use
  213  of nonembryonic stem cells, drugs containing nonembryonic stem
  214  cells, and products containing nonembryonic stem cells in
  215  accordance with the applicable current best practices.
  216         (c)Adverse incident reporting.
  217         (d)Informed consent.
  218         (e)Recordkeeping, record retention, and availability of
  219  records for inspection.
  220         Section 2. The act shall take effect July 1, 2020.
  221  
  222  ================= T I T L E  A M E N D M E N T ================
  223  And the title is amended as follows:
  224         Delete everything before the enacting clause
  225  and insert:
  226                        A bill to be entitled                      
  227         An act relating to nonembryonic stem cell banks;
  228         creating s. 381.06017, F.S.; defining terms; providing
  229         that a nonembryonic stem cell bank that performs
  230         certain functions is deemed a clinic; requiring such
  231         nonembryonic stem cell banks to comply with specified
  232         requirements; prohibiting an entity other than certain
  233         nonembryonic stem cell banks and pharmacists from
  234         dispensing certain compounded drugs or products, with
  235         exceptions; prohibiting certain health care
  236         practitioners from practicing in a nonembryonic stem
  237         cell bank that is not licensed with the agency;
  238         providing for disciplinary action; requiring health
  239         care practitioners to adhere to specified regulations
  240         in the performance of certain procedures; requiring
  241         the agency to adopt specified rules; providing an
  242         effective date.