PART I. 
HAWAII FOOD, DRUG, AND COSMETIC ACT



 



Cross References



 



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



 



§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, 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, 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]



 



Rules of Court



 



  Injunctions, see HRCP rule 65.