CODING: Words stricken are deletions; words underlined are additions.
SENATE AMENDMENT
Bill No. SB 370
Amendment No.
CHAMBER ACTION
Senate House
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11 Senator Myers moved the following amendment:
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13 Senate Amendment (with title amendment)
14 On page 1, between lines 25 and 26,
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17 Section 2. Subsection (6) of section 465.025, Florida
18 Statutes, is amended to read:
19 465.025 Substitution of drugs.--
20 (6) The Board of Pharmacy and the Board of Medicine
21 shall establish by rule a formulary of generic drug type and
22 brand name drug products as defined in 21 C.F.R. section
23 320.33 which meet all of the following criteria: the drug
24 product requires careful patient titration under the
25 supervision of a physician to establish the proper patient
26 dose; the drug product requires routine laboratory monitoring
27 of the patient to maintain the proper patient dose; improper
28 patient dosing can lead to life-threatening adverse events;
29 and the drug is a chronic-care medication involving therapy
30 beyond 30 days which are determined by the boards to
31 demonstrate clinically significant biological or therapeutic
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SENATE AMENDMENT
Bill No. SB 370
Amendment No.
1 inequivalence and which, if substituted, would pose a threat
2 to the health and safety of patients receiving prescription
3 medication.
4 (a) The formulary may be added to or deleted from as
5 the Board of Pharmacy and the Board of Medicine deem
6 appropriate; however, the Board of Pharmacy and the Board of
7 Medicine shall jointly review the formulary not less than once
8 every 2 years to determine whether each of the individual drug
9 products on the formulary continues to meet the criteria
10 established in this subsection. Any person who requests any
11 inclusion, addition, or deletion of a generic drug type or
12 brand name drug product to the formulary shall have the burden
13 of proof to show cause why such inclusion, addition, or
14 deletion should be made.
15 (b) Upon adoption of the formulary required by this
16 subsection, and upon each addition, deletion, or modification
17 to the formulary, the Board of Pharmacy shall mail a copy to
18 each manager of the prescription department of each community
19 pharmacy licensed by the state, each nonresident pharmacy
20 registered in the state, and each board regulating
21 practitioners licensed by the laws of the state to prescribe
22 drugs shall incorporate such formulary into its rules. No
23 pharmacist shall substitute a generically equivalent drug
24 product for a prescribed brand name drug product if the brand
25 name drug product or the generic drug type drug product is
26 included in the the said formulary, unless the prescriber
27 authorizes substitution in advance of dispensing such
28 substitute drug product.
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30 (Redesignate subsequent sections.)
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SENATE AMENDMENT
Bill No. SB 370
Amendment No.
1 ================ T I T L E A M E N D M E N T ===============
2 And the title is amended as follows:
3 On page 1, line 6, after the semicolon,
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5 insert:
6 amending s. 465.025, F,S.; prescribing criteria
7 for inclusion of drugs on the formulary;
8 requiring periodic review of drugs on the
9 formulary; requiring prior physician
10 authorization for substitution of drugs;
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