SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    

                            CHAMBER ACTION
              Senate                               House
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11  Senator Silver moved the following amendment:

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13         Senate Amendment (with title amendment) 

14         On page 55, line 31,

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16  insert:

17         Section 35.  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 which have not been rated as

23  therapeutically equivalent in "Approved Drug Products with

24  Therapeutic Equivalence Evaluations" (Orange Book) published

25  by the Federal Food and Drug Administration, and were not

26  eligible for generic substitution for brand name drug products

27  in at least 40 other states on January 1, 1999 are determined

28  by the boards to demonstrate clinically significant biological

29  or therapeutic inequivalence and which, if substituted, would

30  pose a threat to the health and safety of patients receiving

31  prescription medication.

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1         (a)  The formulary may be added to or deleted from as

 2  the Board of Pharmacy and the Board of Medicine deem

 3  appropriate.  Any person who requests any inclusion, addition,

 4  or deletion of a generic drug type or brand name drug product

 5  to the formulary shall have the burden of proof to show cause

 6  why such inclusion, addition, or deletion should be made.

 7         (b)  Upon adoption of the formulary required by this

 8  subsection, and upon each addition, deletion, or modification

 9  to the formulary, the Board of Pharmacy shall mail a copy to

10  each manager of the prescription department of each community

11  pharmacy licensed by the state, each nonresident pharmacy

12  registered in the state, and each board regulating

13  practitioners licensed by the laws of the state to prescribe

14  drugs shall incorporate such formulary into its rules.  No

15  pharmacist shall substitute a generically equivalent drug

16  product for a prescribed brand name drug product if the brand

17  name drug product or the generic drug type drug product is

18  included in the said formulary, unless the generically

19  equivalent drug product has been rated as therapeutically

20  equivalent in the Orange Book.

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22  (Redesignate subsequent sections.)

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25  ================ T I T L E   A M E N D M E N T ===============

26  And the title is amended as follows:

27         On page 4, line 2, after the second semicolon,

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29  and insert:

30         amending s. 465.025, F.S.; revising

31         requirements for the Board of Pharmacy and the

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    4:55 PM   04/22/99                              s2220c1c-38j01




                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1         Board of Medicine in adopting a formulary of

 2         generic drugs and brand name drugs;

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