Florida Senate - 2020                       CS for CS for SB 512
       
       
        
       By the Committees on Appropriations; and Health Policy; and
       Senator Hutson
       
       
       
       
       576-03986-20                                           2020512c2
    1                        A bill to be entitled                      
    2         An act relating to nonembryonic stem cell banks;
    3         creating s. 381.06017, F.S.; defining terms; providing
    4         that a nonembryonic stem cell bank that performs
    5         certain functions is deemed a clinic; requiring such
    6         nonembryonic stem cell banks to comply with specified
    7         requirements; prohibiting an entity other than certain
    8         nonembryonic stem cell banks and pharmacists from
    9         dispensing certain compounded drugs or products, with
   10         exceptions; prohibiting certain health care
   11         practitioners from practicing in a nonembryonic stem
   12         cell bank that is not licensed with the agency;
   13         providing for disciplinary action; requiring health
   14         care practitioners to adhere to specified regulations
   15         in the performance of certain procedures; requiring
   16         the agency to adopt specified rules; providing a
   17         contingent effective date.
   18          
   19  Be It Enacted by the Legislature of the State of Florida:
   20  
   21         Section 1. Section 381.06017, Florida Statutes, is created
   22  to read:
   23         381.06017 Nonembryonic stem cell banks; collection,
   24  manufacturing, storage, dispensing, and use of human
   25  nonembryonic stem cells.—
   26         (1) DEFINITIONS.—As used in this section, the term:
   27         (a)“Compounding means combining, mixing, or altering the
   28  ingredients of one or more drugs or products to create another
   29  drug or product.
   30         (b)“Dispense” has the same meaning as in s. 465.003(6).
   31         (c)“Establishment” means a place of business which is at
   32  one general physical location and may extend to one or more
   33  contiguous suites, units, floors, or buildings operated and
   34  controlled exclusively by entities under common operation and
   35  control. The term includes multiple buildings with an
   36  intervening thoroughfare if the buildings are under common
   37  exclusive ownership, operation, and control. For purposes of
   38  permitting, each suite, unit, floor, or building must be
   39  identified in the most recent permit application.
   40         (d)“Federal act” means the Federal Food, Drug, and
   41  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
   42         (e)“Minimally manipulated” means:
   43         1.For structural tissue, processing that does not alter
   44  the original characteristics of the tissue which relate to the
   45  tissue’s utility for reconstruction, repair, or replacement; or
   46         2.For cells or nonstructural tissue, processing that does
   47  not alter the relevant biological characteristics of the cell or
   48  tissue.
   49         (f)“Nonembryonic stem cell,” also referred to as a
   50  “somatic stem cell” or an “adult human stem cell,” means an
   51  allogenic or autologous cell that is undifferentiated and
   52  unspecialized and that has the ability to divide for indefinite
   53  periods of time in a medium and to become a specialized cell.
   54  The term includes a human nonembryonic cell that is altered or
   55  processed to become undifferentiated, losing its original
   56  structural function, so that it can be differentiated into a
   57  specialized cell type. The term does not include cells that are
   58  minimally manipulated or are only rinsed, cleaned, or sized and
   59  remain differentiated.
   60         (g)Nonembryonic stem cell bank” means a publicly or
   61  privately owned establishment that does any of the following:
   62         1.Collects and stores human nonembryonic stem cells for
   63  use in a product or patient-specific medical administration.
   64         2.Provides patient-specific health care services using
   65  human nonembryonic stem cells.
   66         3.Advertises human nonembryonic stem cell services,
   67  including, but not limited to, collection, manufacturing,
   68  storage, dispensing, use, or purported use of human nonembryonic
   69  stem cells or products containing human nonembryonic stem cells,
   70  which have not been approved by the United States Food and Drug
   71  Administration or are not the subject of clinical trials
   72  approved by the United States Food and Drug Administration and
   73  which are intended to diagnose, cure, mitigate, treat, provide
   74  therapy for, or prevent an injury or a disease.
   75         4. Performs any procedure that is intended to:
   76         a.Collect or store human nonembryonic stem cells for any
   77  purpose; or
   78         b.Diagnose, cure, mitigate, treat, provide therapy for, or
   79  prevent an injury or a disease with the use or purported use of
   80  human nonembryonic stem cells or any product containing human
   81  nonembryonic stem cells which has not been approved by the
   82  United States Food and Drug Administration or is not the subject
   83  of a clinical trial approved by the United States Food and Drug
   84  Administration.
   85         5.Compounds human nonembryonic stem cells from human
   86  nonembryonic cells or tissue into products by combining, mixing,
   87  or altering the ingredients of one or more drugs or products to
   88  create another drug or product.
   89         6.Manufactures, through recovery, processing,
   90  manipulation, enzymatic digestion, mechanical disruption, or a
   91  similar process, human nonembryonic stem cells from human
   92  nonembryonic cells or tissue into undifferentiated human
   93  nonembryonic stem cells, causing the cells to lose their
   94  original structural function so that the nonembryonic stem cells
   95  may be differentiated into specialized cell types.
   96         7.Dispenses human nonembryonic stem cells and products
   97  containing nonembryonic stem cells to any of the following for a
   98  specific patient pursuant to a valid prescription from a
   99  licensed health care practitioner authorized within the scope of
  100  his or her license to prescribe and administer human
  101  nonembryonic stem cells:
  102         a.A pharmacy permitted under chapter 465.
  103         b.A health care practitioner with privileges to practice
  104  at nonembryonic stem cell banks.
  105         c.A health care practitioner’s office, a health care
  106  facility, or a treatment setting where the health care
  107  practitioner has privileges to practice, for office use.
  108         (h)Office use” means the provision and administration of
  109  a drug, compounded drug, or compounded product to a patient by a
  110  health care practitioner in the practitioner’s office or in a
  111  health care facility or treatment setting, including a hospital,
  112  ambulatory surgery center, or health care clinic licensed under
  113  chapter 395 or chapter 400. The term also includes the
  114  dispensing by a pharmacist at a nonembryonic stem cell bank that
  115  is also permitted as a pharmacy under chapter 465 to a
  116  nonembryonic stem cell bank within this state of any of the
  117  following:
  118         1.Human nonembryonic stem cells.
  119         2.A compounded drug containing human nonembryonic stem
  120  cells.
  121         3.A compounded product containing nonembryonic stem cells.
  122         (2) DUTIES AND REGISTRATION.—A nonembryonic stem cell bank
  123  that advertises, collects, stores, manufactures, dispenses,
  124  compounds, uses, or purports to use nonembryonic stem cells or
  125  products containing nonembryonic stem cells is deemed a clinic
  126  as defined in s. 400.9905 and must comply with all of the
  127  following requirements:
  128         (a)Adhere to the applicable current good manufacturing
  129  practices for the collection, removal, manufacturing,
  130  processing, compounding, and implantation of nonembryonic stem
  131  cells or products containing nonembryonic stem cells pursuant to
  132  the federal act and 21 C.F.R., parts 1270-1271.
  133         (b)Obtain a health care clinic license from the agency
  134  pursuant to s. 400.991 and part II of chapter 408 and register
  135  each establishment separately, unless:
  136         1. The clinic is a facility licensed under chapter 395; or
  137         2. The clinic is affiliated with an accredited medical
  138  school that provides training to medical students, residents, or
  139  fellows.
  140         (c)Have a physician medical director who is responsible
  141  for complying with all requirements related to licensure,
  142  operation of a nonembryonic stem cell bank, and good
  143  manufacturing practices under this section, part X of chapter
  144  400, and the federal act and 21 C.F.R., parts 1270-1271.
  145         (d)Notify the agency in writing on a form approved by the
  146  agency within 10 days after termination of a physician medical
  147  director and notify the agency within 10 days after such
  148  termination of the identity of the physician medical director
  149  who has assumed responsibility for that nonembryonic stem cell
  150  bank. Failure to have a physician medical director practicing at
  151  the location of the licensed nonembryonic stem cell bank shall
  152  be the basis for a summary suspension of the nonembryonic stem
  153  cell bank’s license pursuant to s. 400.607 or s. 120.60(6).
  154         (e)Require a physician medical director to have a full,
  155  active, and unencumbered license issued under chapter 458 or
  156  chapter 459 and to actively practice at the nonembryonic stem
  157  cell bank location for which he or she has assumed
  158  responsibility.
  159         (f)Maintain commercial and professional liability
  160  insurance in an amount not less than $250,000 per claim.
  161         (g)Operate each establishment using the same name as the
  162  one used to obtain the health care clinic license from the
  163  agency. All invoices, packing slips, and other business records
  164  must list the same name.
  165         (h)Obtain a pharmacy permit for each person and
  166  establishment before dispensing, offering office use for the
  167  compounding of human nonembryonic stem cells, or dispensing a
  168  compounded product for office use.
  169         (3)DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
  170         (a)A pharmacist at a nonembryonic stem cell bank that is
  171  also permitted as a pharmacy under chapter 465 may dispense any
  172  of the following to a stem cell bank within the state, for
  173  office use:
  174         1.Human nonembryonic stem cells;
  175         2.A compounded drug containing human nonembryonic stem
  176  cells; or
  177         3.A compounded product containing human nonembryonic stem
  178  cells.
  179         (b)Human nonembryonic stem cells, compounded drugs
  180  containing human nonembryonic stem cells, or products containing
  181  human nonembryonic stem cells may not be sold or dispensed by
  182  any person or establishment other than the nonembryonic stem
  183  cell bank or pharmacist at the nonembryonic stem cell bank that
  184  manufactured the human nonembryonic stem cells or the compounded
  185  drug or product containing human nonembryonic stem cells, except
  186  that:
  187         1.A health care practitioner who requests the dispensing
  188  of the human nonembryonic stem cells, compounded drug, or
  189  compounded product from the manufacturing nonembryonic stem cell
  190  bank may sell or dispense such items to his or her patient if
  191  the health care practitioner is authorized within the scope of
  192  his or her license to prescribe and administer human
  193  nonembryonic stem cells; or
  194         2.A pharmacist, pharmacy, or establishment that requests
  195  the dispensing of the human nonembryonic stem cells, compounded
  196  drug, or compounded product from the manufacturing nonembryonic
  197  stem cell bank may sell or dispense such items to a health care
  198  practitioner who is authorized within the scope of his or her
  199  license to prescribe and administer human nonembryonic stem
  200  cells to patients.
  201         (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
  202         (a) A physician licensed under chapter 458 or chapter 459,
  203  an advanced practice registered nurse licensed under chapter
  204  464, or a physician assistant licensed under chapter 458 or
  205  chapter 459 may not practice in a nonembryonic stem cell bank
  206  that is not licensed with the agency as required by the rules
  207  adopted pursuant to s. 400.9925. The license of a health care
  208  practitioner who violates this paragraph is subject to
  209  disciplinary action by the appropriate regulatory board.
  210         (b) In the performance of any procedure collecting,
  211  storing, using, or purporting to use nonembryonic stem cells or
  212  products containing nonembryonic stem cells, a health care
  213  practitioner must adhere to the applicable current good
  214  manufacturing practices for the collection, removal,
  215  manufacturing, processing, compounding, and implantation of stem
  216  cells or products containing stem cells pursuant to the federal
  217  act and 21 C.F.R., parts 1270-1271.
  218         (5) RULEMAKING.—The agency shall adopt rules necessary to
  219  administer the licensure and regulation of nonembryonic stem
  220  cell banks, including, but not limited to, rules regarding all
  221  of the following, which must be consistent with the best
  222  practices specified in the federal act and 21 C.F.R., parts
  223  1270-1271:
  224         (a)Advertising.
  225         (b)Nonembryonic stem cell bank procedures and protocols
  226  for the collection, manufacturing, storing, dispensing, and use
  227  of nonembryonic stem cells, drugs containing nonembryonic stem
  228  cells, and products containing nonembryonic stem cells in
  229  accordance with the applicable current best practices.
  230         (c)Adverse incident reporting.
  231         (d)Informed consent.
  232         (e)Recordkeeping, record retention, and availability of
  233  records for inspection.
  234         Section 2. This act shall take effect July 1, 2020,
  235  contingent on SB 7066 or similar legislation taking effect on
  236  that same date, if such legislation is adopted in the same
  237  legislative session or an extension thereof and becomes a law.