2016 Hawaii Revised Statutes
TITLE 19. HEALTH
328. Food, Drugs, and Cosmetics
328-1 Definitions.

§328-1 Definitions. For the purposes of this chapter:

"Agent" means a person who acts on behalf of or under the direction of another person.

"Brand" or "brand name" means any registered trade name commonly used to identify a drug.

"Certificate of medical necessity" means the United States Department of Health and Human Services, Health Care Financing Administration's FORM HCFA 484, which identifies the patient-recipient, the supplier, and the prescriber of medical services and establishes an estimated length of time of need for equipment or therapy, or both, to treat the ailment indicated by the diagnosis codes listed thereon.

"Color additive" means a material which:

(1) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; or

(2) When added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto, except that the term does not include any material which has been or hereafter is exempted under the Federal Act;

The term "color" includes black, white, and intermediate grays.

Nothing in this definition shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.

"Computer" means a programmable electronic device, capable of multiple functions including but not limited to storage, retrieval, and processing of information.

"Consumer commodity" means any food, drug, cosmetic, or device as those terms are defined by this part or the Federal Act. The term shall not include:

(1) Any meat or meat products or poultry or poultry products, except as these products are sold at retail in stores and restaurants in normal retail quantities; provided that any labeling requirements imposed under authority of this part shall comply with those established by the Secretary of Agriculture, United States Department of Agriculture;

(2) Any tobacco or tobacco products;

(3) Any commodity subject to packaging and labeling requirements imposed by the Secretary of Agriculture pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act or the provisions of the eighth paragraph under the heading "Bureau of Animal Industry" of the Act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. §§151-158), commonly known as the Virus-Serum-Toxin Act;

(4) Any drug subject to section 503(b)(1) or 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§353(b)(1) and 356);

(5) Any beverage subject to or complying with packaging and labeling requirements imposed under the Federal Alcohol Administration Act (27 U.S.C. §§201-219a); or

(6) Any commodity subject to the Federal Seed Act (7 U.S.C. §§1551-1611).

"Cosmetic" means:

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

(2) Articles intended for use as a component of any such articles, except that the term shall not include soap intended for cleansing purposes only.

"Department" means the department of health.

"Device", except when used (e.g., as an identification device in labeling) in sections 328-3(a), 328-6(10), 328-10(6), 328-15(3), and 328-19(3), means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended:

(1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals; or

(2) To affect the structure or any function of the body of humans or animals.

"Director" means the director of health.

"Downtime" means the period of time that a prescription information processing system is not operable.

"Drug" means:

(1) Articles recognized in the official United States Pharmacopoeia, official United States Pharmacopoeia Dispensing Information, 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 humans or animals;

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

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

"Drug sample" means a unit of a prescription drug that is not to be sold and is distributed to promote the sale of the drug under requirements of Public Law 100-293.

"Electronic prescription" means a prescription or certificate of medical necessity, which is electronically transmitted or conveyed, including a facsimile transmission.

"Established name" or "generic name" when applied to a drug has the meaning given in section 502(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §352(e)(3)).

"Federal Act" means the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040; 21 U.S.C. §§301-395).

"Food" means:

(1) Articles used for food or drink by humans, dogs, or cats;

(2) Chewing gum; or

(3) Articles used for components of any such article.

"Food additive" means any substance, the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if the substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in a food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use, except that the term does not include:

(1) A pesticide chemical in or on a raw agricultural commodity;

(2) A pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity;

(3) A color additive; or

(4) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the Federal Act, the Poultry Products Inspection Act (21 U.S.C. §§451-470), or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. §§601-695).

"Good manufacturing practices for drugs" means requirements for the manufacture, repacking, production, storage, and dispensing of drug products as stated in 21 C.F.R. Parts 207, 210, and 211.

"Legible" means information that is capable of being read and understood.

"Medical oxygen" means the prescription drug oxygen.

"Medical oxygen distributor" means any person, including a licensed prescription drug wholesale distributor, who holds a permit under chapter 461 to distribute or dispense medical oxygen pursuant to a prescription.

"Nonprescription drug", "over-the-counter drug", or "nonlegend drug", means any packaged, bottled, or nonbulk chemical, drug, or medicine that may be lawfully sold without a practitioner's order.

"Official compendium" means the official United States Pharmacopoeia, official United States Pharmacopoeia Dispensing Information, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.

"Out-of-state practitioner" means a physician, surgeon, osteopathic physician and surgeon, advanced practice registered nurse, dentist, podiatrist, or veterinarian authorized to prescribe drugs to patients under the applicable laws of any state of the United States except the State of Hawaii, or a physician, surgeon, osteopathic physician and surgeon, advanced practice registered nurse, dentist, podiatrist, or veterinarian authorized to prescribe drugs under the applicable laws of Hawaii, but practicing in a state other than Hawaii.

"Pesticide chemical" means any substance which, alone, in chemical combination, or in formulation with one or more other substances is an "economic poison" within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. §§135-135k) as amended, and which is used in the production, storage, or transportation of raw agricultural commodities.

"Pharmacist" means a person who is licensed or holds a permit under chapter 461 to practice in a pharmacy, including a pharmacy intern under the immediate and direct supervision of a licensed pharmacist.

"Pharmacy" means a place of business operating as a pharmacy as permitted under chapter 461.

"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.

"Prescriber's authorized agent" means a person, including but not limited to an institutional facility, who acts on behalf of, and under the direction of, the prescribing practitioner.

"Prescription" means an order or formula issued by a practitioner for the compounding or dispensing of drugs, or an order or formula issued by an out-of-state practitioner in compliance with section 328-17.6.

"Prescription drug" means:

(1) Any drug required by federal or state statutes, regulations, or rules to be dispensed only upon a prescription, including finished dosage forms and active ingredients subject to section 328-16 or section 503(b) of the Federal Act; or

(2) Any drug product compounded or prepared pursuant to a practitioner's order.

"Prescription information processing system" means a system for creating, generating, sending, receiving, storing, displaying, or processing prescription information, including but not limited to any electronic hardware, software, or files.

"Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

"Record" means information that is inscribed on a tangible medium or that is stored in an electronic or other medium.

"Supply" means to sell, trade, distribute, exchange, barter, give, offer for sale, lease, rent, or provide.

"21 C.F.R." means Title 21, Code of Federal Regulations. [L 1941, c 318, pt of §2; RL 1945, §2201; RL 1955, §51-1; am L Sp 1959 2d, c 1, §19; am L 1967, c 152, §1; HRS §328-1; am L 1972, c 151, §1; am L 1977, c 200, §1; am L 1983, c 100, §4; am L 1986, c 179, §4; gen ch 1993; am L 1994, c 172, §1; am L 1996, c 208, §1; am L 1997, c 214, §1; am L 2000, c 83, §1; am L 2001, c 124, §2; am L 2003, c 56, §1; am L 2004, c 28, §1; am L 2016, c 183, §2]