2016 Hawaii Revised Statutes
TITLE 19. HEALTH
328. Food, Drugs, and Cosmetics
328-91 Definitions.

Cross References

Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7.

Prescription drug benefits, see chapter 431R.

Prescription drugs; mail order opt out option, see §87A-16.3.

§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.

"Biological product" or "biologic product" has the same meaning as defined in Title 42 United States Code section 262, as the same may be amended.

"Board". DELETED.

"Compendia of therapeutically equivalent generic drug products". DELETED.

"Drug product" means a drug as defined in section 328-1 other than a biological product as defined in this part.

"Equivalent generic drug product" means a drug product approved by the director as substitutable by pharmacists and included in the Hawaii list of equivalent generic drug products and interchangeable biological products.

"Hawaii additions and deletions list". DELETED.

"Hawaii list of equivalent generic drug products and interchangeable biological products" means the list of equivalent generic drug products and interchangeable biological products, which may include references to the Orange Book, the Purple Book, and other published findings and approvals of the United States Food and Drug Administration, created and published by the director pursuant to the director's authority in this part to approve drug products and biological products that pharmacists may substitute with equivalent generic drug products and interchangeable biological products.

"Interchangeable biological product" means a biological product approved by the director as substitutable by pharmacists and included in the Hawaii list of equivalent generic drugs and interchangeable biological products.

"Maximum allowable cost" means the maximum amount that a pharmacy benefit manager shall reimburse a pharmacy for the cost of a drug.

"Maximum allowable cost list" means a list of drugs for which a maximum allowable cost has been established by a pharmacy benefit manager.

"Multiple source drug". DELETED.

"Obsolete" means a drug that may be listed in a national drug pricing compendia but cannot be dispensed based on the expiration date of the last lot manufactured.

"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.

"Purple Book" means the United States Food and Drug Administration's "List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations" publication and its cumulative supplements, which include a list of licensed biological products with biosimilarity and interchangeability evaluations.

"Savings" means the financial benefit derived from utilizing the substituted equivalent generic drug product or interchangeable biological 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; am L 2015, c 175, §2; am L 2016, c 242, §3]