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





                                                  SENATE AMENDMENT

    Bill No. CS/HB 1467, 2nd Eng.

    Amendment No.    

                            CHAMBER ACTION
              Senate                               House
                                   .
                                   .
 1                                 .
                                   .
 2                                 .
                                   .
 3                                 .
                                   .
 4                                                                

 5

 6

 7

 8

 9

10                                                                

11  Senator Brown-Waite moved the following amendment:

12

13         Senate Amendment (with title amendment) 

14         On page 185, between lines 28 and 29,

15

16  insert:

17         Section 127.  Subsection (6) of section 465.025,

18  Florida 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 are determined by the boards to

23  demonstrate clinically significant biological or therapeutic

24  inequivalence and which, if substituted, would pose a threat

25  to the health and safety of patients receiving prescription

26  medication.

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

28  the Board of Pharmacy and the Board of Medicine deem

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

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

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

                                  1
    12:31 PM   04/27/99                             h1467c1c-1018u




                                                  SENATE AMENDMENT

    Bill No. CS/HB 1467, 2nd Eng.

    Amendment No.    





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

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

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

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

 5  each manager of the prescription department of each community

 6  pharmacy licensed by the state, each nonresident pharmacy

 7  registered in the state, and each board regulating

 8  practitioners licensed by the laws of the state to prescribe

 9  drugs shall incorporate such formulary into its rules.  No

10  pharmacist shall substitute a generically equivalent drug

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

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

13  included in the said formulary.

14         (c)  The Department of Health shall study the necessity

15  of retaining drugs currently listed on the negative formulary,

16  taking into consideration whether each such drug has been

17  listed by the Federal Food and Drug Administration in the

18  Orange Book as an Approved Drug Product with Therapeutic

19  Equivalence Evaluations. The Department of Health shall report

20  its conclusions and recommendations to the Legislature by

21  November 1, 1999.

22

23  (Redesignate subsequent sections.)

24

25

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 1, line 3, delete the word "practitioners;"

29

30  insert:

31         ; amending s. 465.025, F.S.; requiring the

                                  2
    12:31 PM   04/27/99                             h1467c1c-1018u




                                                  SENATE AMENDMENT

    Bill No. CS/HB 1467, 2nd Eng.

    Amendment No.    





 1         Department of Health to study the necessity of

 2         retaining certain drugs on the negative

 3         formulary; requiring a report to the

 4         Legislature;

 5

 6

 7

 8

 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

                                  3
    12:31 PM   04/27/99                             h1467c1c-1018u