§328-96 Drug formulary. (a) The board may adopt rules, pursuant to chapter 91, to effectuate the purpose of this part. Without regard to chapter 91, the board may adopt as rules the Orange Book and its cumulative supplements once they are issued by the Commissioner of Food and Drugs, United States Food and Drug Administration, as the state drug formulary of equivalent drug products. The board may adopt rules, pursuant to chapter 91, to establish a Hawaii additions and deletions list; provided that section 328-92(d) shall apply, and no pharmacist shall substitute an equivalent drug product for any prescription for an anti-epileptic drug to treat epilepsy, except upon the consent of the practitioner and the patient or the patient's parent or guardian. Upon the adoption of the Orange Book or its cumulative supplements, the board shall notify all pharmacies in the State and other interested individuals, within thirty working days, that the formulary has been updated. The Hawaii additions and deletions list may list additional substitutable drug products that are determined by the board to be safe, effective, and therapeutically equivalent. The Hawaii additions and deletions list may delete drug products listed in the Orange Book upon the board's finding that product quality or therapeutic equivalency or bioequivalency, as appropriate, is not adequately assured.

(b) Pursuant to chapter 91, the Hawaii additions and deletions list may be changed, added to, or deleted from as the board deems appropriate. Any person who requests that any change be made or that a generic name or brand name drug be included or added to or deleted from the Hawaii additions and deletions list shall have the burden of proof to show cause why the change, inclusion, addition, or deletion should be made.

(c) The board shall revise or supplement the Hawaii additions and deletions list as necessary.

(d) The department shall provide for distribution of the Hawaii additions and deletions list and its revisions and supplements to all pharmacies in the State and to any other interested individuals. The department may establish fees to be charged to persons who receive the Hawaii additions and deletions list and its revisions and supplements. The amounts of the fees charged for the Hawaii additions and deletions list and its revisions and supplements shall be approximately the same as the costs of producing and distributing the Hawaii additions and deletions list and its revisions and supplements.

(e) Each pharmacy in the State shall:

(f) The department shall provide for public education regarding the provisions of this part and shall monitor the effects of this part. [L 1980, c 187, pt of §1; am L 1982, c 122, §1(6), (7); am L 1986, c 174, §1; am L 1996, c 209, §6; am L 1997, c 214, §7; am L 1999, c 209, §2]