Florida Senate - 2013                        COMMITTEE AMENDMENT
       Bill No. CS for SB 732
       
       
       
       
       
       
                                Barcode 613416                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/25/2013           .                                
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       The Committee on Appropriations (Galvano) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Subsection (6) of section 465.019, Florida
    6  Statutes, is amended to read:
    7         465.019 Institutional pharmacies; permits.—
    8         (6) In a Class II institutional pharmacy, an institutional
    9  formulary system may be adopted with approval of the medical
   10  staff for the purpose of identifying those medicinal drugs, and
   11  proprietary preparations, biologics, biosimilars, and biosimilar
   12  interchangeables that may be dispensed by the pharmacists
   13  employed in such institution. A facility with a Class II
   14  institutional permit which is operating under the formulary
   15  system shall establish policies and procedures for the
   16  development of the system in accordance with the joint standards
   17  of the American Hospital Association and American Society of
   18  Hospital Pharmacists for the utilization of a hospital formulary
   19  system, which formulary shall be approved by the medical staff.
   20         Section 2. Section 465.0252, Florida Statutes, is created
   21  to read:
   22         465.0252 Substitution of interchangeable biosimilar
   23  products.—
   24         (1) As used in this section, the terms “biological
   25  product,” “biosimilar,” and “interchangeable” have the same
   26  meanings as defined in s. 351 of the federal Public Health
   27  Service Act, 42 U.S.C. s. 262.
   28         (2) A pharmacist may only dispense a substitute biological
   29  product for the prescribed biological product if:
   30         (a) The United States Food and Drug Administration has
   31  determined that the substitute biological product is biosimilar
   32  to and interchangeable for the prescribed biological product.
   33         (b) The prescribing health care provider does not express a
   34  preference against substitution in writing, verbally, or
   35  electronically.
   36         (c) The pharmacist notifies the person presenting the
   37  prescription of the substitution in the same manner as provided
   38  in s. 465.025(3)(a).
   39         (d) The pharmacist retains a written or electronic record
   40  of the substitution for at least 2 years.
   41         (3) A pharmacist who practices in a class II or modified
   42  class II institutional pharmacy shall comply with the
   43  notification provisions of paragraph (2)(c) by entering the
   44  substitution in the institution’s written medical record system
   45  or electronic medical record system.
   46         (4) The board shall maintain on its public website a
   47  current list of biological products that the United States Food
   48  and Drug Administration has determined are biosimilar and
   49  interchangeable as provided in paragraph (2)(a).
   50         Section 3. This act shall take effect July 1, 2013.
   51  
   52  ================= T I T L E  A M E N D M E N T ================
   53         And the title is amended as follows:
   54         Delete everything before the enacting clause
   55  and insert:
   56                        A bill to be entitled                      
   57         An act relating to pharmacy; amending s. 465.019,
   58         F.S.; permitting a class II institutional pharmacy
   59         formulary to include biologics, biosimilars, and
   60         biosimilar interchangeables; creating s. 465.0252,
   61         F.S.; providing definitions; providing requirements
   62         for a pharmacist to dispense a substitute biological
   63         product that is determined to be biosimilar to and
   64         interchangeable for the prescribed biological product;
   65         providing notification requirements for a pharmacist
   66         in a class II or modified class II institutional
   67         pharmacy; requiring the Board of Pharmacy to maintain
   68         a current list of interchangeable biosimilar products;
   69         providing an effective date.