Definitions
HRS §328-91
in effect328-91. 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.
"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 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 drug products
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.
"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 "Lists of Licensed Biological Products with
Reference Product Exclusivity and Biosimilarity or Interchangeability
Evaluations" publication and its cumulative supplements, which include lists
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; am L 2017, c 12,
§63]
Source: Hawaii State Legislature (capitol.hawaii.gov), via Internet Archive capturesURL: http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0328/HRS_0328-0091.htmFetched: 11/10/2026