CODING: Words stricken are deletions; words underlined are additions.





                                                  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 to amendment

12  (333964):

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14         Senate Amendment (with title amendment) 

15         On page 276, between lines 26 and 27,

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17  insert:

18         Section 201.  Subsection (6) of section 465.025,

19  Florida Statutes, is amended to read:

20         465.025  Substitution of drugs.--

21         (6)  The Board of Pharmacy and the Board of Medicine

22  shall establish by rule a formulary of generic drug type and

23  brand name drug products which have not been rated as

24  therapeutically equivalent in "Approved Drug Products with

25  Therapeutic Equivalence Evaluations" (Orange Book) published

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

27  eligible for generic substitution for brand name drug products

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

29  by the boards to demonstrate clinically significant biological

30  or therapeutic inequivalence and which, if substituted, would

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

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1  prescription medication.

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

 3  the Board of Pharmacy and the Board of Medicine deem

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

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

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

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

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

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

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

11  each manager of the prescription department of each community

12  pharmacy licensed by the state, each nonresident pharmacy

13  registered in the state, and each board regulating

14  practitioners licensed by the laws of the state to prescribe

15  drugs shall incorporate such formulary into its rules.  No

16  pharmacist shall substitute a generically equivalent drug

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

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

19  included in the said formulary, unless the generically

20  equivalent drug product has been rated as therapeutically

21  equivalent in the Orange Book.

22

23  (Redesignate subsequent sections.)

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

27  And the title is amended as follows:

28         On page 296, line 29, after the semicolon,

29

30  insert:

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

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1         requirements for the Board of Pharmacy and the

 2         Board of Medicine in adopting a formulary of

 3         generic drugs and brand name drugs;

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