Florida Senate - 2013                       CS for CS for SB 732
       
       
       
       By the Committees on Appropriations; and Health Policy; and
       Senator Grimsley
       
       
       
       576-04910-13                                           2013732c2
    1                        A bill to be entitled                      
    2         An act relating to pharmacy; amending s. 465.019,
    3         F.S.; permitting a Class II institutional pharmacy
    4         formulary to include biologics, biosimilars, and
    5         biosimilar interchangeables; creating s. 465.0252,
    6         F.S.; providing definitions; providing requirements
    7         for a pharmacist to dispense a substitute biological
    8         product that is determined to be biosimilar to and
    9         interchangeable for the prescribed biological product;
   10         providing notification requirements for a pharmacist
   11         in a Class II or Modified Class II institutional
   12         pharmacy; requiring the Board of Pharmacy to maintain
   13         a current list of interchangeable biosimilar products;
   14         providing an effective date.
   15  
   16  Be It Enacted by the Legislature of the State of Florida:
   17  
   18         Section 1. Subsection (6) of section 465.019, Florida
   19  Statutes, is amended to read:
   20         465.019 Institutional pharmacies; permits.—
   21         (6) In a Class II institutional pharmacy, an institutional
   22  formulary system may be adopted with approval of the medical
   23  staff for the purpose of identifying those medicinal drugs, and
   24  proprietary preparations, biologics, biosimilars, and biosimilar
   25  interchangeables that may be dispensed by the pharmacists
   26  employed in such institution. A facility with a Class II
   27  institutional permit which is operating under the formulary
   28  system shall establish policies and procedures for the
   29  development of the system in accordance with the joint standards
   30  of the American Hospital Association and American Society of
   31  Hospital Pharmacists for the utilization of a hospital formulary
   32  system, which formulary shall be approved by the medical staff.
   33         Section 2. Section 465.0252, Florida Statutes, is created
   34  to read:
   35         465.0252 Substitution of interchangeable biosimilar
   36  products.—
   37         (1) As used in this section, the terms “biological
   38  product,” “biosimilar,” and “interchangeable” have the same
   39  meanings as defined in s. 351 of the federal Public Health
   40  Service Act, 42 U.S.C. s. 262.
   41         (2) A pharmacist may only dispense a substitute biological
   42  product for the prescribed biological product if:
   43         (a) The United States Food and Drug Administration has
   44  determined that the substitute biological product is biosimilar
   45  to and interchangeable for the prescribed biological product.
   46         (b) The prescribing health care provider does not express a
   47  preference against substitution in writing, verbally, or
   48  electronically.
   49         (c) The pharmacist notifies the person presenting the
   50  prescription of the substitution in the same manner as provided
   51  in s. 465.025(3)(a).
   52         (d) The pharmacist retains a written or electronic record
   53  of the substitution for at least 2 years.
   54         (3) A pharmacist who practices in a Class II or Modified
   55  Class II institutional pharmacy shall comply with the
   56  notification provisions of paragraph (2)(c) by entering the
   57  substitution in the institution’s written medical record system
   58  or electronic medical record system.
   59         (4) The board shall maintain on its public website a
   60  current list of biological products that the United States Food
   61  and Drug Administration has determined are biosimilar and
   62  interchangeable as provided in paragraph (2)(a).
   63         Section 3. This act shall take effect July 1, 2013.