Florida Senate - 2013                          SENATOR AMENDMENT
       Bill No. CS/CS/HB 365, 1st Eng.
       
       
       
       
       
       
                                Barcode 683776                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                 Floor: WD/2R          .                                
             04/29/2013 01:03 PM       .                                
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       Senator Grimsley moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 24 - 46
    4  and insert:
    5  proprietary preparations, biological products, biosimilars, and
    6  biosimilar interchangeables that may be dispensed by the
    7  pharmacists employed in such institution. A facility with a
    8  Class II institutional permit which is operating under the
    9  formulary system shall establish policies and procedures for the
   10  development of the system in accordance with the joint standards
   11  of the American Hospital Association and American Society of
   12  Hospital Pharmacists for the utilization of a hospital formulary
   13  system, which formulary shall be approved by the medical staff.
   14         Section 2. Section 465.0252, Florida Statutes, is created
   15  to read:
   16         465.0252 Substitution of interchangeable biosimilar
   17  products.—
   18         (1) As used in this section, the terms “biological
   19  product,” “biosimilar,” and “interchangeable” have the same
   20  meanings as defined in s. 351 of the federal Public Health
   21  Service Act, 42 U.S.C. s. 262.
   22         (2) A pharmacist may dispense a substitute biological
   23  product for the prescribed biological product only if all of the
   24  following conditions are met:
   25         (a) The United States Food and Drug Administration has
   26  determined that the substitute biological product is biosimilar
   27  to and interchangeable for the prescribed biological product.
   28         (b) The practitioner ordering the prescription does not
   29  express
   30  
   31  ================= T I T L E  A M E N D M E N T ================
   32         And the title is amended as follows:
   33         Delete line 4
   34  and insert:
   35         formulary to include biological products, biosimilars,
   36         and