§461-1  Definitions.  For the purposes
of this chapter:



"Board" means the board of pharmacy
of the State except where another meaning is clearly manifested by the context.



"Continuing education courses" means
courses approved by the American College of Pharmaceutical Education or
continuing medical education courses that serve to improve patient safety and
to maintain quality national standards in the prevention of medical errors.



"Cosmetics", which includes
"soap", "dentifrice", and "toilet article", means:



(1)  Articles intended to be rubbed, poured, or
sprinkled on, introduced into, or otherwise applied to the human body, or any
part thereof, for cleansing, beautifying, or promoting attractiveness; and



(2)  Articles intended for use as a component of any
such articles.



"Credit hour", except as otherwise
provided, means the value assigned to sixty minutes of instruction.



"Director" means the director of
commerce and consumer affairs.



"Drug" means:



(1)  Articles recognized in the official United States
pharmacopoeia, official homeopathic pharmacopoeia of the United States, or
official national formulary, or any supplement to any of them;



(2)  Articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in human beings or animals;



(3)  Articles (other than food or clothing) intended
to affect the structure or any function of the body of human beings or animals;
and



(4)  Articles intended for use as a component of any
articles specified in paragraph (1), (2), or (3), above; provided that the term
"drug" shall not include devices or their components, parts, or
accessories, cosmetics, or liquor as defined in section 281-1.



"Emergency contraception" means a
drug that:



(1)  Is used postcoitally;



(2)  Prevents pregnancy by delaying ovulation,
preventing fertilization of an egg, or preventing implantation of an egg in a
uterus; and



(3)  Is approved by the United States Food and Drug
Administration.



"Encumbered license" means a license
issued by any state or territory of the United States for the practice of
pharmacy which is revoked, suspended, or made probationary or conditional by
the licensing or registering authority in the respective jurisdiction as a
result of disciplinary action.



"Institutional facility" [Repealed
on July 1, 2010.  L 2004, c 190, §11.] means an organization or facility
whose primary purpose is to provide a physical environment for patients to
obtain health care services or at-home care services, and that uses the
services of an on-site pharmacy, an off-site pharmacy, or a pharmacist
contractor at which medication storage is managed by personnel of the
facility.  "Institutional facility" includes but is not limited to a:



(1)  Hospital;



(2)  Convalescent home;



(3)  Skilled nursing facility;



(4)  Intermediate care facility;



(5)  Extended care facility;



(6)  Rehabilitation center;



(7)  Health maintenance organization clinic;



(8)  Psychiatric center;



(9)  Mental retardation center;



(10)  Penal institution;



(11)  Hospice facility;



(12)  Supervised living group; or



(13)  Prescribing practitioner's office.



"Licensed physician" means a
physician or osteopathic physician licensed by the Hawaii medical board
pursuant to chapter 453.



"Medical oxygen" means the
prescription drug oxygen.



"Medical oxygen distributor" means
any person, including a prescription drug wholesale distributor, who
distributes or dispenses medical oxygen pursuant to a prescription.



"Multiple dose container" [Repealed
on July 1, 2010.  L 2004, c 190, §11.] means a multiple unit container for articles
intended for parenteral administration only.



"Multiple unit container" [Repealed
on July 1, 2010.  L 2004, c 190, §11.] means a container that permits
withdrawal of successive portions of the contents without changing the
strength, quality, or purity of the remaining portion.



"Pharmacy" means every store, shop,
or place:



(1)  Where prescription drugs are dispensed or sold at
retail, or displayed for sale at retail;



(2)  Where practitioners' prescriptions or drug
preparations are compounded;



(3)  That has upon it, displayed within it, or affixed
to or used in connection with it, a sign bearing the words
"pharmacist", "pharmacy", "apothecary",
"drug store", "druggist", "drugs", "medicines",
"medicine store", "drug sundries", "remedies", or
any words of similar or like import; or



(4)  Where any of the above words or combination of
words are used in any advertisement.



The term "pharmacy" shall not include any
medical oxygen distributor.



"Practice of pharmacy" means:



(1)  The interpretation and evaluation of prescription
orders; the compounding, dispensing, and labeling of drugs and devices (except
labeling by a manufacturer, packer, or distributor of nonprescription drugs and
commercially legend drugs and devices); the participation in drug selection and
drug utilization reviews; the proper and safe storage of drugs and devices and
the maintenance of proper records therefore; the responsibility for advising
when necessary or where regulated, of therapeutic values, content, hazards, and
use of drugs and devices;



(2)  Performing the following procedures or functions
as part of the care provided by and in concurrence with a "health care
facility" and "health care service" as defined in section
323D-2, or a "pharmacy" or a licensed physician, or a "managed care
plan" as defined in section 432E-1, in accordance with policies,
procedures, or protocols developed collaboratively by health professionals,
including physicians and surgeons, pharmacists, and registered nurses, and for
which a pharmacist has received appropriate training required by these
policies, procedures, or protocols:



(A)  Ordering or performing routine drug
therapy related patient assessment procedures;



(B)  Ordering drug therapy related laboratory
tests;



(C)  Initiating emergency contraception oral
drug therapy in accordance with a written collaborative agreement approved by
the board, between a licensed physician and a pharmacist who has received
appropriate training that includes programs approved by the American Council of
Pharmaceutical Education (ACPE), curriculum-based programs from an
ACPE-accredited college of pharmacy, state or local health department programs,
or programs recognized by the board of pharmacy;



(D)  Administering drugs orally, topically, by
intranasal delivery, or by injection, pursuant to the patient's licensed
physician's order, by a pharmacist having appropriate training that includes
programs approved by the ACPE, curriculum-based programs from an
ACPE-accredited college of pharmacy, state or local health department programs,
or programs recognized by the board of pharmacy;



(E)  Administering immunizations orally, by
injection, or by intranasal delivery, to persons eighteen years of age or
older, by a pharmacist having appropriate training that includes programs approved
by the ACPE, curriculum-based programs from an ACPE-accredited college of
pharmacy, state or local health department programs, or programs recognized by
the board of pharmacy;



(F)  As authorized by a licensed physician's
written instructions, initiating or adjusting the drug regimen of a patient
pursuant to an order or authorization made by the patient's licensed physician
and related to the condition for which the patient has been seen by the
licensed physician; provided that the pharmacist shall issue written
notification to the patient's licensed physician or enter the appropriate
information in an electronic patient record system shared by the licensed
physician, within twenty-four hours;



(G)  Transmitting a valid prescription to
another pharmacist for the purpose of filling or dispensing; or



(H)  Providing consultation, information, or
education to patients and health care professionals based on the pharmacist's
training and for which no other licensure is required; and



(3)  The offering or performing of those acts,
services, operations, or transactions necessary in the conduct, operation,
management, and control of pharmacy.



"Practitioner" means an individual
licensed by the State or authorized by the laws of the State to prescribe
prescription drugs within the scope of the person's practice.



"Prescription" means an order or
formula issued by a practitioner licensed by the State or authorized by the
laws of the State to prescribe prescription drugs within the scope of the
practitioner's practice, for the compounding or dispensing of drugs or an order
or formula issued by an out-of-state practitioner in compliance with chapter
328.



"Prescription drug" means any drug
dispensed, distributed, or sold pursuant to a practitioner's order.



"Registered pharmacist" means a
person licensed under this chapter to practice in a pharmacy except where
another meaning is clearly manifested by the context.



"Remote dispensing" [Repealed
on January 2, 2014.  L 2009, c 96, §3.] means the practice of
dispensing drugs through the use of trained personnel, telecommunications, and
information technologies to patients at a remote dispensing pharmacy.



"Remote dispensing machine" [Repealed
on January 2, 2014.  L 2009, c 96, §3.] means a device used for
dispensing unit-of-use drugs that are acquired pursuant to section 340B of the
Public Health Service Act, Title 42 United States Code section 256b, that is
operated using information technologies and is located in a remote dispensing
pharmacy.



"Remote dispensing pharmacy" [Repealed
on January 2, 2014.  L 2009, c 96, §3.] means the area in an
institutional facility, including a federally qualified health center,
providing outpatient medical care in any county, by dispensing prescription
drugs that are acquired pursuant to section 340B of the Public Health Service
Act, Title 42 United States Code section 256b, through the use of a remote
dispensing machine.



"Remote dispensing technician" [Repealed
on January 2, 2014.  L 2009, c 96, §3.] means an individual who
assists the pharmacist in various activities specific to the remote dispensing
pharmacy.



"Responsible pharmacy" [Repealed
on January 2, 2014.  L 2009, c 96, §3.] means a pharmacy that
operates a remote dispensing machine located in this State and holds a valid
permit issued by the board pursuant to section 461-14.



"Single dose container" [Repealed on
July 1, 2010.  L 2004, c 190, §11.] means a single unit container
for articles intended for parenteral administration only.  A single dose
container is labeled as such.  Examples of single dose containers include
pre-filled syringes, cartridges, fusion sealed containers, and closure-sealed
containers when so labeled.



"Single unit container" [Repealed on
July 1, 2010.  L 2004, c 190, §11.] is one that is designed to hold a quantity
of drug product intended for administration as a single dose or a single
finished device intended for use promptly after the container is opened. 
Preferably, the immediate container and the outer container or protective
packaging shall be so designed as to show evidence of any tampering with the
contents.  Each single unit container shall be labeled to indicate the
identity, quantity and strength, name of the manufacturer, lot number, and
expiration date of the article.



"Single user unit" [Repealed on July
1, 2010.  L 2004, c 190, §11.] means any single unit container, single dose
container, unit dose container, unit of use container, or multiple unit
container provided for the exclusive use by a single patient.



"Unit dose container" [Repealed on
July 1, 2010.  L 2004, c 190, §11.] means a single unit container for
articles intended for administration by other than the parenteral route as a
single dose, direct from the container.



"Unit of use container" [Repealed on
July 1, 2010.  L 2004, c 190, §11.] means one that contains a specific
quantity of a drug product and that is intended to be dispensed as such without
further modification except for the addition of appropriate labeling.  A unit
of use container is labeled as such. [L 1949, c 175, pt of §1; RL 1955, §71-1;
am L 1964, c 15, §4; HRS §461-1; am L 1986, c 143, §4; am L 1987, c 188, §1; am
L 1995, c 34, §1; am L 1996, c 202, §11; am L 1997, c 214, §8; am L 2000, c 83,
§6; am L 2002, c 256, §2; am L 2003, c 201, §2; am L 2004, c 165, §2, c 190,
§6, and c 239, §1; am L 2008, c 9, §3 and c 212, §3; am L 2009, c 11, §62]



 



Note



 



  The following acts exempted their amendments from the repeal
and reenactment condition of L 2004, c 190, §11:



  L 2004, cc 165, §2 and 239, §1 as amended by L 2005, c 22,
§§52, 53.



  L 2008, c 9, §3 and c 212, §3 as amended by L 2009, c 11, §§11,
20.



  L 2009, c 11, §§62, 76(3).



  The 2009 amendment to the definition of "licensed
physician" is retroactive to April 3, 2008.  L 2009, c 11, §76(2).



 



Law Journals and Reviews



 



  Emergency Contraception in Religious Hospitals:  The Struggle
Between Religious Freedom and Personal Autonomy.  27 UH L. Rev. 65.



  Compelled Expression of the Religiously Forbidden: 
Pharmacists, "Duty to Fill" Statutes, and the Hybrid Rights Exception. 
29 UH L. Rev. 97.