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:
35 465.0252 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 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.