Florida Senate - 2013                              CS for SB 732
       
       
       
       By the Committee on Health Policy; and Senator Grimsley
       
       
       
       
       588-03414A-13                                          2013732c1
    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, biological products, biosimilars, and
   25  biosimilar interchangeables that may be dispensed by the
   26  pharmacists employed in such institution. A facility with a
   27  Class II institutional permit which is operating under the
   28  formulary 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         465.0252Substitution 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 practitioner ordering the prescription does not
   47  express a preference against substitution in writing, verbally,
   48  or 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 or the pharmacist’s agent, within 5
   53  business days after dispensing the substitute biological product
   54  in lieu of the prescribed biological product, notifies the
   55  practitioner ordering the prescription of the substitution by
   56  facsimile, telephone, voicemail, e-mail, electronic medical
   57  record, or other electronic means.
   58         (e) The pharmacist and the practitioner ordering the
   59  prescription each retain a written or electronic record of the
   60  substitution for at least 2 years.
   61         (3)A pharmacist who practices in a class II or modified
   62  class II institutional pharmacy shall comply with the
   63  notification provisions of paragraphs (2)(c) and (d) by entering
   64  the substitution in the institution’s written medical record
   65  system or electronic medical record system.
   66         (4)The board shall maintain on its public website a
   67  current list of biological products that the United States Food
   68  and Drug Administration has determined are biosimilar and
   69  interchangeable as provided in paragraph (2)(a).
   70         Section 3. This act shall take effect July 1, 2013.