PART VI. DRUG PRODUCT SELECTION

 

§328-91  Definitions.  As used in thispart:

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

"Bioequivalents" means chemicalequivalents which, when administered to the same individuals in the same dosageregimen, will result in comparable bioavailability, as defined by the FederalFood and Drug Administration.

"Board" means the drug productselection board.

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

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

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

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

"Equivalentgeneric drug product" means a drug product with the sameestablished name, active ingredient strength, quantity, and dosage form as thedrug product identified in the prescription, and:  (1) that is listed astherapeutically equivalent (i.e., addition) in the current Hawaii additions anddeletions list; or (2) that is listed in the compendia of therapeuticallyequivalent generic drug products and is not listed as therapeuticallyinequivalent (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 hasdetermined to be safe, effective, and therapeutically equivalent generic drugproducts but are not in the compendia oftherapeutically 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, therapeuticallyequivalent, or bioequivalent generic drug products.

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

"Orange Book" means the United StatesFood and Drug Administration's "Approved Drug Products with TherapeuticEquivalence Evaluations" publication and its cumulative supplements, whichinclude a list of approved prescription drug products with therapeuticequivalence evaluations.

"Savings" means the financial benefitderived from utilizing the substituted equivalent generic drug product from theperspective of the consumer or the ultimate payer, including third partypayers.

"United States Food and DrugAdministration-approved generic drug product with therapeutic equivalencyevaluations" means a generic drug product approved for marketing by theUnited States Food and Drug Administration pursuant to 21 C.F.R. part 314 andwith established bioequivalency to the referenced brand drug pursuant to 21C.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; amL 2004, c 28, §2]

 

Revision Note

 

  Numeric designations deleted.