Hawaii Administrative Rules › Title 16 - DEPARTMENT OF COMMERCE AND CONSUMER AFFAIRS › Chapter 95 - PHARMACISTS AND PHARMACIES › Subchapter 1 - GENERAL PROVISIONS › Section 16-95-2 - Definitions

Current through June, 2024
As used in this chapter unless the context clearly indicates
				  otherwise:
"ACPE" means the Accreditation Council for Pharmacy
				  Education, formerly known as the American Council on Pharmaceutical Education,
				  which is the national agency for the accreditation of professional degree
				  programs in pharmacy and providers of continuing pharmacy education.
"Automated data processing system" or "ADP system" means a
				  system utilizing computer software and hardware for the purpose of record
				  keeping.
"Board" means the board of pharmacy.
"BREG" means the business registration division of the
				  department.
"Department" means the department of commerce and consumer
				  affairs.
"Director" means the director of commerce and consumer
				  affairs.
"Dispense" or "dispensing" means the furnishing of drugs
				  pursuant to a prescription in a suitable container, appropriately labeled for
				  subsequent administration to, or use by, a patient or other individual entitled
				  to receive the drug.
"HAR" means the Hawaii Administrative Rules.
"HRS" means the Hawaii Revised Statutes.
"Immediate supervision" means that a registered pharmacist is
				  physically present in the area or location where a pharmacy intern or pharmacy
				  technician is working and oversees the correctness and accuracy of the
				  prescription's ingredients, quantity, and label.
"Institutional facility" includes a:
(1) Hospital;
(2) Convalescent home;
(3) Nursing home;
(4) Extended care facility;
(5) Mental institution;
(6) Rehabilitation center;
(7) Health maintenance organization;
(8) Psychiatric center;
(9) Mental retardation center;
(10) Penal institution; or
(11) Any other organization whose primary purpose is to
				  provide a physical environment for patients to obtain health care services or
				  at-home care services, except those places where physicians, dentists,
				  veterinarians, osteopaths, podiatrists, or other prescribers who are duly
				  licensed, engage in private practice.
"Institutional pharmacy" means a pharmacy providing services
				  to an institutional facility
"NABPLEX" means the National Association of Boards of
				  Pharmacy Licensure Examination, now known as the NAPLEX.
"NAPLEX" means the North American Pharmacist Licensure
				  Examination, previously known as the NABPLEX.
"Partnership" means a general partnership, a limited
				  partnership, a limited liability partnership, or a limited liability limited
				  partnership.
"Pharmacy intern" means a student or graduate of a school or
				  college of pharmacy, that is accredited or is a candidate for accreditation by
				  the ACPE, and who is issued a permit by the board to work under the immediate
				  supervision of a registered pharmacist.
"Pharmacy technician" means a nonlicensed individual, other
				  than a pharmacy intern, who assists the pharmacist in various activities under
				  the immediate supervision of a registered pharmacist.
"Wholesale distribution" means the transfer of prescription
				  drugs to persons other than a consumer or patient, but does not include:
(1) Intracompany sales, defined as any transaction or
				  transfer between an entity and any division, subsidiary, parent, or affiliated
				  or related company under common ownership and control;
(2) The purchase or other acquisition, by an institutional
				  facility that is a member of a group purchasing organization, of a drug for use
				  by the entity's patient, from the group purchasing organization or from other
				  institutional facilities that are members of the group purchasing
				  organization;
(3) The sale, purchase, or trade of a drug or an offer to
				  sell, purchase, or trade a drug by a charitable organization described in
				  section 501(c)(3) of the Internal Revenue Code of 1986, as amended, to a
				  nonprofit affiliate of the organization to the extent otherwise permitted by
				  law;
(4) The sale, purchase, or trade of a drug or an offer to
				  sell, purchase, or trade a drug among institutional facilities that are under
				  common control. For purposes of this paragraph, "common control" means the
				  power to direct or cause the direction of the management and policies of a
				  person or an organization, whether by ownership of stock, working rights by
				  contract, or otherwise;
(5) The sale, purchase, or trade of a drug or an offer to
				  sell, purchase, or trade a drug for emergency medical reasons. For purposes of
				  this paragraph, "emergency medical reasons" includes but is not limited to
				  transfers of prescription drugs by a pharmacy to another pharmacy to alleviate
				  a temporary shortage, except that the gross dollar value of the transfers shall
				  not exceed five per cent of the total prescription drug sales revenue of either
				  the transferor or transferee pharmacy during any period of twelve consecutive
				  months;
(6) The sale, purchase, or trade of a drug, or an offer to
				  sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a
				  prescription;
(7) The distribution of drug samples by manufacturers'
				  representatives or distributors' representatives. For purposes of this
				  paragraph, "drug sample" means a unit of a prescription drug that is not
				  intended to be sold and is intended to promote the sale of the drug; or
(8) The sale, purchase, or trade of blood and blood
				  components intended for transfusion. For purposes of this paragraph, "blood"
				  means whole blood collected from a single donor and processed either for
				  transfusion or further manufacturing; and "blood component" means that part of
				  blood separated by physical or mechanical means.
"Wholesale distributor" means any person or entity in this
				  State engaged in the transfer of prescription drugs to a person other than a
				  consumer or patient, including but not limited to, manufacturers; repackers;
				  own label distributors; private label distributors; jobbers; brokers;
				  warehouses, including manufacturers' and distributors' warehouses, chain drug
				  warehouses, and wholesale drug warehouses; independent wholesale drug traders;
				  prescription drug repackagers; practitioners; birth control and other clinics;
				  individuals; hospitals; nursing homes and their providers; health maintenance
				  organizations and other health care providers; and retail and hospital
				  pharmacies that conduct wholesale distributions. The term "wholesale
				  distributor" shall not include any carrier for hire or person or entity hired
				  solely to transport prescription drugs. For purposes of this definition,
				  "manufacturer" means anyone who is engaged in manufacturing, preparing,
				  propagating, compounding, processing, packaging, repackaging, or labeling of a
				  prescription drug; and "prescription drug" means any human drug required by
				  federal law or regulation to be dispensed only by a prescription, including
				  finished dosage forms and active ingredients subject to section 503(b) of the
				  Federal Food, Drug, and Cosmetic Act.