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

"Advanced practice registered nurse" means a person licensed pursuant to section 457-8.5 and granted prescriptive authority pursuant to section 457-8.6.

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

"Caregiver" means an individual who has an established personal or professional relationship with the individual at risk for an opioid overdose.

"CLIA-waived tests" means any test that is classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a).

"Continuing education courses" means courses approved by the Accreditation Council for Pharmacy Education.

"Contraceptive supplies" means all United States Food and Drug Administration-approved self-administered hormonal contraceptives.

"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.

"End-user's external accessible device" means a commercially available computer, mobile phone, or other communications device that is able to receive electronic information transmitted from an external source and provide the electronic information in a form and format accessible to the individual.

"Family member" means an individual who can provide assistance and is related to the individual at risk for an opioid overdose.

"Institutional facility" 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) Intellectual disability 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.

"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 therefor; the responsibility for advising when necessary or where regulated, of therapeutic values, content, hazards, and use of drugs and devices; and the interpretation and evaluation of prescription orders to adjust the supply dispensed for purposes of medication synchronization pursuant to section 431:10A-606, 432:1-621, or 432D-30;

(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, a licensed physician assistant, or a licensed advanced practice registered nurse with prescriptive authority; 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, physician assistants, 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, physician assistant, or advanced practice registered nurse with prescriptive authority and a pharmacist who has received appropriate training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board;

(D) Administering drugs orally, topically, by intranasal delivery, or by injection, pursuant to the order of the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, 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;

(E) Administering:

(i) 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;

(ii) Vaccines to persons between fourteen and seventeen years of age pursuant to section 461-11.4; and

(iii) Human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, and influenza vaccines to persons between eleven and seventeen years of age pursuant to section 461-11.4;

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

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

(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; or

(I) Prescribing and dispensing an opioid antagonist pursuant to section 461-11.8;

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

(4) Prescribing and dispensing contraceptive supplies pursuant to section 461-11.6; and

(5) Notwithstanding any other law to the contrary, and in accordance with the requirements of section 461-11.2, ordering, performing, and reporting the results of the following CLIA-waived tests:

(A) Blood glucose;

(B) Hemoglobin A1C;

(D) Human immunodeficiency virus;

(E) Influenza;

(F) Respiratory syncytial virus;

(G) SARS-CoV-2; or

(H) Streptococcal pharyngitis.

"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.

"Prescription drug reader" means a dedicated electronic device that is able to obtain information from an electronic label affixed to a container of prescription drugs and provide the information in an audio format accessible to the individual.

"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 machine" means a device used for dispensing unit-of-use drugs that is operated using information technologies and is located in a remote dispensing pharmacy.

"Remote dispensing pharmacy" means the area in an institutional facility, including a federally qualified health center that provides outpatient medical care in any county, where prescription drugs are dispensed through the use of a remote dispensing machine.

"Territory" means Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, or American Samoa.

"Unit of use container" 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, 11 and c 239, §1; am L 2008, c 9, §3 and c 212, §§3, 7; am L 2009, c 11, §62 and c 96, §3; am L 2010, c 50, §2 and c 51, §2; am L 2011, c 220, §12; am L 2012, c 24, §2 and c 42, §3; am L 2013, c 184, §2; am L 2015, c 36, §1; am L 2016, c 68, §3 and c 183, §9; am L 2017, c 67, §5 and c 68, §2; am L 2018, c 154 §3 and c 197, §5; am L 2022, c 293, §12; am L 2023, c 103, §3 and c 256, §3]

Note

The L 2012, c 24, §2 amendment applies to license renewals for the licensing biennium beginning January 1, 2014. L 2012, c 24, §4.

The L 2010, c 51 amendment is exempt from the January 2, 2014 repeal and reenactment condition of L 2009, c 96, §3. L 2010, c 51, §5.

Law Journals and Reviews

Emergency Contraception in Religious Hospitals: The Struggle Between Religious Freedom and Personal Autonomy. 27 UH L. Rev. 65 (2004).

Compelled Expression of the Religiously Forbidden: Pharmacists, "Duty to Fill" Statutes, and the Hybrid Rights Exception. 29 UH L. Rev. 97 (2006).