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,and24 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.