HAR §16-95-2. Definitions

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; §16-95-2 95-6 (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; §16-95-2 95-7 (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; §16-95-2 95-8 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. [Eff 5/16/64; am 8/7/70; am and ren §16-95-2, 6/22/81; am and comp 12/24/92; comp 12/25/04; am and comp 06/22/15; am and comp 8/15/16] (Auth: HRS §461-4.5) (Imp: HRS §461-4.5)