§461-1 - Definitions.
§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"Institutional facility" [Repealed on July 1, 2010.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.