Drug Formulary

Permitting the Board of Health to designate the Orange Book,
published by the FDA, as the state generic drug formulary. (CD1)

THE SENATE                              S.B. NO.           S.D. 1
TWENTIETH LEGISLATURE, 1999                                H.D. 2
STATE OF HAWAII                                            C.D. 1

                   A  BILL  FOR  AN  ACT



 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 included in the Orange
10           Book, but the board has determined not to be safe,
11           effective, therapeutically equivalent, or bioequivalent
12           generic drug products.
13      "Orange Book" means the United States Food and Drug
14 Administration's "Approved Drug Products with Therapeutic
15 Equivalence Evaluations" publication and its cumulative
16 supplements, which include a list of approved prescription drug
17 products with therapeutic equivalence evaluations."
18      SECTION 2.  Section 328-96, Hawaii Revised Statutes, is
19 amended to read as follows:

Page 2                                                     1018
                                     S.B. NO.           S.D. 1
                                                        H.D. 2
                                                        C.D. 1

 1      "328-96  Drug formulary.(a)  The board [shall] may adopt
 2 rules, pursuant to chapter 91, [for the establishment and
 3 maintenance of a state drug formulary of equivalent drug
 4 products, and] to effectuate the purpose of this part[; except
 5 that the board may, without].  Without regard to chapter 91, 
 6 [establish in the formulary equivalent drug products that] the
 7 board may adopt as rules the Orange Book and its cumulative
 8 supplements once they are issued by the Commissioner of Food and
 9 Drugs, United States Food and Drug Administration, [has approved
10 as safe and effective and has determined to be therapeutically
11 equivalent.  The formulary shall list all drug products that the
12 Commissioner of Food and Drugs, United States Food and Drug
13 Administration, has approved as safe and effective and has
14 determined to be therapeutically equivalent.] as the state drug
15 formulary of equivalent drug products.  The board may adopt
16 rules, pursuant to chapter 91, to establish a Hawaii additions
17 and deletions list; provided that section 328-92(d) shall apply,
18 and no pharmacist shall substitute an equivalent drug product for
19 any prescription for an anti-epileptic drug to treat epilepsy,
20 except upon the consent of the practitioner and the patient or
21 the patient's parent or guardian.  Upon the adoption of the
22 Orange Book or its cumulative supplements, the board shall notify
23 all pharmacies in the State and other interested individuals,

Page 3                                                     1018
                                     S.B. NO.           S.D. 1
                                                        H.D. 2
                                                        C.D. 1

 1 within thirty working days, that the formulary has been updated.
 2 The [formulary] Hawaii additions and deletions list may list
 3 additional substitutable drug products that are determined by the
 4 board to [meet requirements adequate to assure product quality
 5 and therapeutic equivalence.] be safe, effective, and
 6 therapeutically equivalent.  The [formulary] Hawaii additions and
 7 deletions list may delete [approved drugs] drug products listed
 8 in the Orange Book upon [a] the board's finding that product
 9 quality or therapeutic equivalency or bioequivalency, as
10 appropriate, is not adequately assured.
11      (b)  [The formulary] Pursuant to chapter 91, the Hawaii
12 additions and deletions list may be changed, added to, or deleted
13 from as the board deems appropriate.  Any person who requests
14 that any change be made or that a generic name or brand name drug
15 be included or added to or deleted from the [formulary] Hawaii
16 additions and deletions list shall have the burden of proof to
17 show cause why the change, inclusion, addition, or deletion
18 should be made.
19      (c)  The board shall [provide for revision or
20 supplementation of the formulary] revise or supplement the Hawaii
21 additions and deletions list as necessary [but not less than
22 annually].
23      (d)  The department [of health] shall provide for

Page 4                                                     1018
                                     S.B. NO.           S.D. 1
                                                        H.D. 2
                                                        C.D. 1

 1 distribution of the [formulary,] Hawaii additions and deletions
 2 list and its revisions[,] and supplements to all pharmacies in
 3 the State and to any other interested individuals.  The
 4 department [of health] may establish fees to be charged to
 5 persons who receive the [formulary,] Hawaii additions and
 6 deletions list and its revisions[,] and supplements.  The amounts
 7 of the fees charged for the [formulary,] Hawaii additions and
 8 deletions list and its revisions[,] and supplements shall be
 9 approximately the same as the costs of producing and distributing
10 the [formulary,] Hawaii additions and deletions list and its
11 revisions[,] and supplements.
12      (e)  Each pharmacy in the State shall:
13      (1)  Obtain, maintain, and update the Orange Book and its
14           cumulative supplements; and
15      (2)  Obtain the Hawaii additions and deletions list.
16      [(e)] (f)  The department shall provide for public education
17 regarding the provisions of this part and shall monitor the
18 effects of this part."
19      SECTION 3.  Statutory material to be repealed is bracketed.
20 New statutory material is underscored.
21      SECTION 4.  This Act shall take effect upon its approval.