HOUSE OF REPRESENTATIVES                H.B. NO.           1136
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 new definitions to be appropriately inserted
 
 3 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 in the Orange Book; and
 
 8      (2)  A list of drug products that are in the Orange Book but
 
 9           the board has determined not to be safe, effective,
 
10           therapeutically equivalent, or bioequivalent.
 
11      "Orange Book" means the "Approved Drug Products with
 
12 Therapeutic Equivalence Evaluations" which consists of drug
 
13 products that the Commissioner of Food and Drugs, United States
 
14 Food and Drug Administration, has approved as safe and effective
 
15 and therapeutically equivalent."
 
16      SECTION 2.  Section 328-96, Hawaii Revised Statutes, is
 
17 amended to read as follows:
 
18      "328-96  Drug formulary.(a)  The board [shall] may adopt
 
19 rules, pursuant to chapter 91, [for the establishment and
 

 
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 1 maintenance of a state drug formulary of equivalent drug
 
 2 products, and] to effectuate the purpose of this part[; except
 
 3 that the board may without].  Without regard to chapter 91,
 
 4 [establish in the formulary equivalent drug products that] the
 
 5 board may adopt as rules the Orange Book and its supplements once
 
 6 they are issued by the Commissioner of Food and Drugs, United
 
 7 States Food and Drug Administration, [has approved as safe and
 
 8 effective and has determined to be therapeutically equivalent.  
 
 9 The formulary shall list all drug products that the Commissioner
 
10 of Food and Drugs, United States Food and Drug Administration,
 
11 has approved as safe and effective and has determined to be
 
12 therapeutically equivalent.] as the state drug formulary of
 
13 equivalent drug products.  Pursuant to chapter 91, the board may
 
14 establish and maintain as rules a Hawaii additions and deletions
 
15 list; provided that as required by subsection 328-92(d), the
 
16 pharmacist shall not substitute an equivalent drug product for
 
17 any prescription for an anti-epileptic drug, except upon the
 
18 consent of the practitioner and the patient or the patient's
 
19 parent or guardian.  The [formulary] Hawaii additions and
 
20 deletions list may list additional substitutable drug products
 
21 that are determined by the board to [meet requirements adequate
 
22 to assure product quality and therapeutic equivalence.] be safe,
 
23 effective, and therapeutically equivalent.  The [formulary]
 

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

 
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 1 of the fees charged for the [formulary,] Hawaii additions and
 
 2 deletions list and its revisions[,] and supplements shall be
 
 3 approximately the same as the costs of producing and distributing
 
 4 the [formulary,] Hawaii additions and deletions list and its
 
 5 revisions[,] and supplements.
 
 6      [(e)  The department of health shall provide for public
 
 7 education regarding the provisions of this part and shall monitor
 
 8 the effects of this part.]
 
 9      (e)  Each pharmacy in the State shall be responsible for:
 
10      (1)  Obtaining, maintaining, and updating the Orange Book
 
11           and its supplements; and
 
12      (2)  Obtaining the Hawaii additions and deletions list.
 
13      (f)  The department shall provide for public education
 
14 regarding the provisions of this part and shall monitor the
 
15 effects of this part."
 
16      SECTION 3.  Statutory material to be repealed is bracketed.
 
17 New statutory material is underscored.
 
18      SECTION 4.  This Act shall take effect upon its approval.
 
19 
 
20                           INTRODUCED BY:  _______________________
 

 
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