Florida Senate - 2013 COMMITTEE AMENDMENT
Bill No. SB 732
Barcode 178606
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/02/2013 .
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The Committee on Health Policy (Galvano) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsection (6) of section 465.019, Florida
6 Statutes, is amended to read:
7 465.019 Institutional pharmacies; permits.—
8 (6) In a Class II institutional pharmacy, an institutional
9 formulary system may be adopted with approval of the medical
10 staff for the purpose of identifying those medicinal drugs, and
11 proprietary preparations, biological products, biosimilars, and
12 biosimilar interchangeables that may be dispensed by the
13 pharmacists employed in such institution. A facility with a
14 Class II institutional permit which is operating under the
15 formulary system shall establish policies and procedures for the
16 development of the system in accordance with the joint standards
17 of the American Hospital Association and American Society of
18 Hospital Pharmacists for the utilization of a hospital formulary
19 system, which formulary shall be approved by the medical staff.
20 Section 2. Section 465.0252, Florida Statutes, is created
21 to read:
22 465.0252 Substitution of interchangeable biosimilar
23 products.—
24 (1) As used in this section, the terms “biological
25 product,” “biosimilar,” and “interchangeable” have the same
26 meanings as defined in s. 351 of the federal Public Health
27 Service Act, 42 U.S.C. s. 262.
28 (2) A pharmacist may only dispense a substitute biological
29 product for the prescribed biological product if:
30 (a) The United States Food and Drug Administration has
31 determined that the substitute biological product is biosimilar
32 to and interchangeable for the prescribed biological product.
33 (b) The practitioner ordering the prescription does not
34 express a preference against substitution in writing, verbally,
35 or electronically.
36 (c) The pharmacist notifies the person presenting the
37 prescription of the substitution in the same manner as provided
38 in s. 465.025(3)(a).
39 (d) The pharmacist or the pharmacist’s agent, within 5
40 business days after dispensing the substitute biological product
41 in lieu of the prescribed biological product, notifies the
42 practitioner ordering the prescription of the substitution by
43 facsimile, telephone, voicemail, e-mail, electronic medical
44 record, or other electronic means.
45 (e) The pharmacist and the practitioner ordering the
46 prescription each retain a written or electronic record of the
47 substitution for at least 2 years.
48 (3) A pharmacist who practices in a class II or modified
49 class II institutional pharmacy shall comply with the
50 notification provisions of paragraphs (2)(c) and (d) by entering
51 the substitution in the institution’s written medical record
52 system or electronic medical record system.
53 (4) The board shall maintain on its public website a
54 current list of biological products that the United States Food
55 and Drug Administration has determined are biosimilar and
56 interchangeable as provided in paragraph (2)(a).
57 Section 3. This act shall take effect July 1, 2013.
58
59 ================= T I T L E A M E N D M E N T ================
60 And the title is amended as follows:
61 Delete everything before the enacting clause
62 and insert:
63 A bill to be entitled
64 An act relating to pharmacy; amending s. 465.019,
65 F.S.; permitting a class II institutional pharmacy
66 formulary to include biologics, biosimilars, and
67 biosimilar interchangeables; creating s. 465.0252,
68 F.S.; providing definitions; providing requirements
69 for a pharmacist to dispense a substitute biological
70 product that is determined to be biosimilar to and
71 interchangeable for the prescribed biological product;
72 providing notification requirements for a pharmacist
73 in a class II or modified class II institutional
74 pharmacy; requiring the Board of Pharmacy to maintain
75 a current list of interchangeable biosimilar products;
76 providing an effective date.