Florida Senate - 2013                                     SB 732
       
       
       
       By Senator Grimsley
       
       
       
       
       21-00224-13                                            2013732__
    1                        A bill to be entitled                      
    2         An act relating to prescription drugs; providing
    3         definitions; authorizing a pharmacist to substitute a
    4         biosimilar product for a prescribed product if certain
    5         requirements are met; providing an effective date.
    6  
    7  Be It Enacted by the Legislature of the State of Florida:
    8  
    9         Section 1. (1) As used in this section, the term:
   10         (a) “Biological product” means a virus; therapeutic serum;
   11  toxin; antitoxin; vaccine; blood; blood component or derivative;
   12  allergenic product; protein, except any chemically synthesized
   13  polypeptide, or analogous product; arsphenamine or derivative of
   14  arsphenamine, or any other trivalent organic arsenic compound,
   15  which is used to prevent, treat, or cure a disease or condition
   16  of a human being.
   17         (b) “Biosimilar” means that a biological product is highly
   18  similar to a prescribed product notwithstanding minor
   19  differences in clinically inactive components. There must not be
   20  any clinically meaningful differences between the biological
   21  product and the prescribed product with regard to the safety,
   22  purity, and potency of the product.
   23         (c) “Interchangeable” means a biological product may be
   24  substituted for the prescribed product without the intervention
   25  of the prescriber.
   26         (d) “Prescriber” means a practitioner licensed to prescribe
   27  medicinal drugs.
   28         (2) A pharmacist may substitute a biosimilar product for a
   29  prescribed product if:
   30         (a) The United States Food and Drug Administration has
   31  determined that the biosimilar product is interchangeable with
   32  the prescribed product for the specified, indicated use;
   33         (b) The prescriber does not express in writing, verbally,
   34  or electronically a preference against the substitution;
   35         (c) The person presenting the prescription is notified of
   36  the substitution in a manner consistent with the requirements of
   37  section 465.025(3), Florida Statutes;
   38         (d) The pharmacist or pharmacist’s agent notifies the
   39  prescriber or the prescriber’s agent by facsimile, telephone,
   40  voicemail, e-mail, or other electronic means of the substitution
   41  within 10 business days after receiving the prescription; and
   42         (e) The pharmacist and prescriber retain a written record
   43  of the biosimilar substitution for at least 4 years.
   44         Section 2. This act shall take effect July 1, 2013.