PART VI. 
DRUG PRODUCT SELECTION



 



§328-91  Definitions.  As used in this
part:



"Agent" means a person under the
direct supervision of a pharmacist, acting in the pharmacist's presence.



"Bioequivalents" means chemical
equivalents which, when administered to the same individuals in the same dosage
regimen, will result in comparable bioavailability, as defined by the Federal
Food and Drug Administration.



"Board" means the drug product
selection board.



"Compendia of therapeutically equivalent
generic drug products" means the Orange Book and any United States Food
and Drug Administration documentation of any United States Food and Drug
Administration-approved generic drug product with therapeutic equivalency
evaluations, including but not limited to:



(1)  Letters of approval of Abbreviated New Drug
Applications with therapeutic equivalency evaluations;



(2)  Published listings of approved New Drug
Applications or approved Abbreviated New Drug Applications with therapeutic
equivalency evaluations; and



(3)  Listings of first time generics with therapeutic
equivalency evaluations, adopted by the director.



"Equivalent
generic drug product" means a drug product with the same
established name, active ingredient strength, quantity, and dosage form as the
drug product identified in the prescription, and:  (1) that is listed as
therapeutically equivalent (i.e., addition) in the current Hawaii additions and
deletions list; or (2) that is listed in the compendia of therapeutically
equivalent generic drug products and is not listed as therapeutically
inequivalent (i.e., deletion) in the Hawaii additions and deletions list.



"Hawaii additions and deletions list"
means:



(1)  A list of drug products that the board has
determined to be safe, effective, and therapeutically equivalent generic drug
products but are not in the compendia of
therapeutically equivalent generic drugs; and



(2)  A list of drug products that are included in the compendia of therapeutically equivalent generic drugs,
but that the board has determined not to be safe, effective, therapeutically
equivalent, or bioequivalent generic drug products.



"Multiple source drug" means a drug
marketed or sold by two or more manufacturers or labelers or a drug marketed or
sold by the same manufacturer or labeler under two or more different brand
names, or both, under a brand name and without such a name.



"Orange Book" means the United States
Food and Drug Administration's "Approved Drug Products with Therapeutic
Equivalence Evaluations" publication and its cumulative supplements, which
include a list of approved prescription drug products with therapeutic
equivalence evaluations.



"Savings" means the financial benefit
derived from utilizing the substituted equivalent generic drug product from the
perspective of the consumer or the ultimate payer, including third party
payers.



"United States Food and Drug
Administration-approved generic drug product with therapeutic equivalency
evaluations" means a generic drug product approved for marketing by the
United States Food and Drug Administration pursuant to 21 C.F.R. part 314 and
with established bioequivalency to the referenced brand drug pursuant to 21
C.F.R. part 320. [L 1980, c 187, pt of §1; am L 1982, c 122, §1(3); am L 1996,
c 209, §2; am L 1997, c 214, §10; am L 1999, c 209, §1; am L 2003, c 56, §5; am
L 2004, c 28, §2]



 



Revision Note



 



  Numeric designations deleted.