PART I. HAWAII FOOD, DRUG, AND COSMETIC ACT

 

Cross References

 

  Food safety education program, see §§321-401 to 405.

 

§328-1  Definitions.  For the purposesof this chapter:

"Agent" means a person who acts onbehalf 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 CareFinancing Administration's FORM HCFA 484, which identifies thepatient-recipient, the supplier, and the prescriber of medical services andestablishes an estimated length of time of need for equipment or therapy, orboth, to treat the ailment indicated by the diagnosis codes listed thereon.

"Color additive" means a materialwhich:

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

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

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

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

"Computer" means a programmableelectronic device, capable of multiple functions including but not limited tostorage, retrieval, and processing of information.

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

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

(2)  Any tobacco or tobacco products;

(3)  Any commodity subject to packaging and labelingrequirements imposed by the Secretary of Agriculture pursuant to the FederalInsecticide, Fungicide, and Rodenticide Act or the provisions of the eighthparagraph under the heading "Bureau of Animal Industry" of the Act ofMarch 4, 1913 (37 Stat. 832-833; 21 U.S.C. §§151-158), commonly known as theVirus-Serum-Toxin Act;

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

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

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

"Cosmetic" means:

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

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

"Department" means the department ofhealth.

"Device", except when used (e.g., asan 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, andcontrivances, 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 thebody of humans or animals.

"Director" means the director ofhealth.

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

"Drug" means:

(1)  Articles recognized in the official United StatesPharmacopoeia, official United States Pharmacopoeia Dispensing Information,official Homeopathic Pharmacopoeia of the United States, or official NationalFormulary, 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) intendedto affect the structure or any function of the body of humans or animals; or

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

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

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

"Established name" or "genericname" when applied to a drug has the meaning given in section 502(e)(3) ofthe 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 thecharacteristics of any food (including any substance intended for use inproducing, manufacturing, packing, processing, preparing, treating, packaging,transporting, or holding food; and including any source of radiation intendedfor any such use), if the substance is not generally recognized, among expertsqualified by scientific training and experience to evaluate its safety, as havingbeen adequately shown through scientific procedures (or, in the case of asubstance used in a food prior to January 1, 1958, through either scientificprocedures or experience based on common use in food) to be safe under theconditions of its intended use, except that the term does not include:

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

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

(3)  A color additive; or

(4)  Any substance used in accordance with a sanctionor approval granted prior to the enactment of the Food Additives Amendment of1958, pursuant to the Federal Act, the Poultry Products Inspection Act (21U.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 fordrugs" 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 iscapable of being read and understood.

"Medical oxygen" means theprescription drug oxygen.

"Medical oxygen distributor" meansany person, including a licensed prescription drug wholesale distributor, whoholds a permit under chapter 461 to distribute or dispense medical oxygenpursuant to a prescription.

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

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

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

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

"Pharmacist" means a person who islicensed or holds a permit under chapter 461 to practice in a pharmacy, includinga pharmacy intern under the immediate and direct supervision of a licensedpharmacist.

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

"Practitioner" means an individuallicensed by the State or authorized by the laws of the State to prescribeprescription drugs within the scope of the person's practice.

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

"Prescription" means an order orformula issued by a practitioner for the compounding or dispensing of drugs, oran order or formula issued by an out-of-state practitioner in compliance withsection 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, includingfinished dosage forms and active ingredients subject to section 328-16 orsection 503(b) of the Federal Act; or

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

"Prescription information processingsystem" means a system for creating, generating, sending, receiving,storing, displaying, or processing prescription information, including but notlimited to any electronic hardware, software, or files.

"Raw agricultural commodity" meansany 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 isinscribed on a tangible medium or that is stored in an electronic or othermedium.

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

"21 C.F.R." means Title 21, Code ofFederal 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 ch1993; am L 1994, c 172, §1; am L 1996, c 208, §1; am L 1997, c 214, §1; am L2000, c 83, §1; am L 2001, c 124, §2; am L 2003, c 56, §1; am L 2004, c 28, §1]

 

Rules of Court

 

  Injunctions, see HRCP rule 65.