REPORT TITLE:
Drug formulary

DESCRIPTION:
Permitting the Board of Health to designate the Orange Book,
published by the FDA, as the state generic drug formulary.
(HB1136 HD1)


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                        1136
HOUSE OF REPRESENTATIVES                H.B. NO.           H.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           generic drug products but are not in the Orange Book;
 
 8           and
 
 9      (2)  A list of drug products that are in the Orange Book but
 
10           the board has determined not to be safe, effective,
 
11           therapeutically equivalent, or bioequivalent generic
 
12           drug products.
 
13      "Orange Book" means the "Approved Drug Products with
 
14 Therapeutic Equivalence Evaluations" which consists of drug
 
15 products that the Commissioner of Food and Drugs, United States
 
16 Food and Drug Administration, has approved as safe and effective
 
17 and therapeutically equivalent generic drug products."
 
18      SECTION 2.  Section 328-96, Hawaii Revised Statutes, is
 
19 amended to read as follows:
 
20      "328-96  Drug formulary.(a)  The board [shall] may adopt
 

 
Page 2                                                     1136
                                     H.B. NO.           H.D. 1
                                                        
                                                        

 
 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 once
 
 7 they are issued by the Commissioner of Food and Drugs, United
 
 8 States Food and Drug Administration, [has approved as safe and
 
 9 effective and 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.  Pursuant to chapter 91, the board may
 
15 establish and maintain as rules a Hawaii additions and deletions
 
16 list; provided that, as required by subsection 328-92(d), the
 
17 pharmacist shall not substitute an equivalent drug product for
 
18 any prescription for an anti-epileptic drug, except upon the
 
19 consent of the practitioner and the patient or the patient's
 
20 parent or guardian.  The [formulary] Hawaii additions and
 
21 deletions list may list additional substitutable drug products
 
22 that are determined by the board to [meet requirements adequate
 
23 to assure product quality and therapeutic equivalence.] be safe,
 

 
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                                     H.B. NO.           H.D. 1
                                                        
                                                        

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

 
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                                     H.B. NO.           H.D. 1
                                                        
                                                        

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