REPORT TITLE:
Drug Formulary


DESCRIPTION:
Allows the Drug Product Selection Board to adopt the Orange Book
as a state drug formulary.  (SD1)

 
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                                                        1018
THE SENATE                              S.B. NO.           S.D. 1
TWENTIETH LEGISLATURE, 1999                                
STATE OF HAWAII                                            
                                                             
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                   A  BILL  FOR  AN  ACT

RELATING TO THE DRUG FORMULARY.



BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 1      SECTION 1.  Section 328-91, Hawaii Revised Statutes, is
 
 2 amended by adding two new definitions to be appropriately
 
 3 inserted and to read as follows:
 
 4      ""Hawaii additions and deletions list" means:
 
 5      (1)  A list of drug products that the board has determined
 
 6           to be safe, effective, and therapeutically equivalent,
 
 7           but are not included in the orange book; and
 
 8      (2)  A list of drug products that are included in the orange
 
 9           book, but the board has determined not to be safe,
 
10           effective, therapeutically equivalent, or
 
11           bioequivalent.
 
12      "Orange book" means the "Approved Drug Products with
 
13 Therapeutic Equivalence Evaluations", consisting of drug products
 
14 that the Commissioner of Food Drugs, United States Food and Drug
 
15 Administration, has approved as safe and effective and
 
16 therapeutically equivalent."
 
17      SECTION 2.  Section 328-96, Hawaii Revised Statutes, is
 
18 amended to read as follows:
 
19      "§328-96  Drug formulary.(a)  The board [shall] may adopt
 

 
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 1 rules, pursuant to chapter 91, [for the establishment and
 
 2 maintenance of a state drug formulary of equivalent drug
 
 3 products, and] to effectuate the purpose of this part[; except
 
 4 that the board may without].  Without regard to chapter 91,
 
 5 [establish in the formulary equivalent drug products that] the
 
 6 board may adopt as rules the orange book and its supplements as
 
 7 issued by the Commissioner of Food and Drugs, United States Food
 
 8 and Drug Administration, [has approved as safe and effective and
 
 9 has determined to be therapeutically equivalent.  
 
10 The formulary shall list all drug products that the Commissioner
 
11 of Food and Drugs, United States Food and Drug Administration,
 
12 has approved as safe and effective and has determined to be
 
13 therapeutically equivalent.] as the state drug formulary of
 
14 equivalent drug products.  The board may adopt rules, pursuant to
 
15 chapter 91, to establish a Hawaii additions and deletions list;
 
16 provided that section 328-92(d) shall apply.  The [formulary]
 
17 Hawaii additions and deletions list may list additional
 
18 substitutable drug products that are determined by the board to
 
19 [meet requirements adequate to assure product quality and
 
20 therapeutic equivalence.] be safe, effective, and therapeutically
 
21 equivalent.  The [formulary] Hawaii additions and deletions list
 
22 may delete [approved drugs] drug products listed in the orange
 
23 book upon [a] the board's finding that product quality or
 
24 therapeutic equivalency or bioequivalency, as appropriate, is not
 

 
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 1 adequately assured.
 
 2      (b)  [The formulary] Pursuant to chapter 91, the Hawaii
 
 3 additions and deletions list may be changed, added to, or deleted
 
 4 from as the board deems appropriate.  Any person who requests
 
 5 that any change be made or that a generic name or brand name drug
 
 6 be included or added to or deleted from the [formulary] Hawaii
 
 7 additions and deletions list shall have the burden of proof to
 
 8 show cause why the change, inclusion, addition, or deletion
 
 9 should be made.
 
10      (c)  The board shall [provide for revision or
 
11 supplementation of the formulary] revise or supplement the Hawaii
 
12 additions and deletions list as necessary [but not less than
 
13 annually].
 
14      (d)  The department [of health] shall provide for
 
15 distribution of the [formulary,] Hawaii additions and deletions
 
16 list and its revisions[,] and supplements to all pharmacies in
 
17 the State and to any other interested individuals.  The
 
18 department [of health] may establish fees to be charged to
 
19 persons who receive the [formulary,] Hawaii additions and
 
20 deletions list and its revisions[,] and supplements.  The amounts
 
21 of the fees charged for the [formulary,] Hawaii additions and
 
22 deletions list and its revisions[,] and supplements shall be
 
23 approximately the same as the costs of producing and distributing
 

 
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 1 the [formulary,] Hawaii additions and deletions list and its
 
 2 revisions[,] and supplements.
 
 3      (e)  Each pharmacy in the State shall be responsible for:
 
 4      (1)  Obtaining, maintaining, and updating the orange book
 
 5           and its supplements for the pharmacy's own use; and
 
 6      (2)  Obtaining the Hawaii additions and deletions list.
 
 7      [e] (f)  The department of health shall provide for public
 
 8 education regarding the provisions of this part and shall monitor
 
 9 the effects of this part."
 
10      SECTION 3.  Statutory material to be repealed is bracketed.
 
11 New statutory material is underscored.
 
12      SECTION 4.  This Act shall take effect upon its approval.
 

 
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