Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. CS for SB 512
       
       
       
       
       
       
                                Ì315950&Î315950                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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       The Committee on Appropriations (Hutson) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 169 - 236
    4  and insert:
    5         (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
    6         (a) A pharmacist at a nonembryonic stem cell bank that is
    7  also permitted as a pharmacy under chapter 465 may dispense any
    8  of the following to a stem cell bank within the state, for
    9  office use:
   10         1. Human nonembryonic stem cells;
   11         2. A compounded drug containing human nonembryonic stem
   12  cells; or
   13         3. A compounded product containing human nonembryonic stem
   14  cells.
   15         (b) Human nonembryonic stem cells, compounded drugs
   16  containing human nonembryonic stem cells, or products containing
   17  human nonembryonic stem cells may not be sold or dispensed by
   18  any person or establishment other than the nonembryonic stem
   19  cell bank or pharmacist at the nonembryonic stem cell bank that
   20  manufactured the human nonembryonic stem cells or the compounded
   21  drug or product containing human nonembryonic stem cells, except
   22  that:
   23         1. A health care practitioner who requests the dispensing
   24  of the human nonembryonic stem cells, compounded drug, or
   25  compounded product from the manufacturing nonembryonic stem cell
   26  bank may sell or dispense such items to his or her patient if
   27  the health care practitioner is authorized within the scope of
   28  his or her license to prescribe and administer human
   29  nonembryonic stem cells; or
   30         2. A pharmacist, pharmacy, or establishment that requests
   31  the dispensing of the human nonembryonic stem cells, compounded
   32  drug, or compounded product from the manufacturing nonembryonic
   33  stem cell bank may sell or dispense such items to a health care
   34  practitioner who is authorized within the scope of his or her
   35  license to prescribe and administer human nonembryonic stem
   36  cells to patients.
   37         (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
   38         (a) A physician licensed under chapter 458 or chapter 459,
   39  an advanced practice registered nurse licensed under chapter
   40  464, or a physician assistant licensed under chapter 458 or
   41  chapter 459 may not practice in a nonembryonic stem cell bank
   42  that is not licensed with the agency as required by the rules
   43  adopted pursuant to s. 400.9925. The license of a health care
   44  practitioner who violates this paragraph is subject to
   45  disciplinary action by the appropriate regulatory board.
   46         (b) In the performance of any procedure collecting,
   47  storing, using, or purporting to use nonembryonic stem cells or
   48  products containing nonembryonic stem cells, a health care
   49  practitioner must adhere to the applicable current good
   50  manufacturing practices for the collection, removal,
   51  manufacturing, processing, compounding, and implantation of stem
   52  cells or products containing stem cells pursuant to the federal
   53  act and 21 C.F.R., parts 1270-1271.
   54         (5) RULEMAKING.—The agency shall adopt rules necessary to
   55  administer the licensure and regulation of nonembryonic stem
   56  cell banks, including, but not limited to, rules regarding all
   57  of the following, which must be consistent with the best
   58  practices specified in the federal act and 21 C.F.R., parts
   59  1270-1271:
   60         (a) Advertising.
   61         (b) Nonembryonic stem cell bank procedures and protocols
   62  for the collection, manufacturing, storing, dispensing, and use
   63  of nonembryonic stem cells, drugs containing nonembryonic stem
   64  cells, and products containing nonembryonic stem cells in
   65  accordance with the applicable current best practices.
   66         (c) Adverse incident reporting.
   67         (d) Informed consent.
   68         (e) Recordkeeping, record retention, and availability of
   69  records for inspection.
   70         Section 2. This act shall take effect July 1, 2020,
   71  contingent on SB 7066 or similar legislation taking effect on
   72  that same date, if such legislation is adopted in the same
   73  legislative session or an extension thereof and becomes a law.
   74  
   75  ================= T I T L E  A M E N D M E N T ================
   76  And the title is amended as follows:
   77         Delete lines 16 - 17
   78  and insert:
   79         the agency to adopt specified rules; providing a
   80         contingent effective date.