Hawaii · statute · Haw. Rev. Stat. ch. 328 · 92 active provisions
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 Ca…
"Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this part that any word, statement, or other information appears on the label shall not be considered to be complied with unless the word, statement, or other infor…
(a) If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading, there shall be taken into account (among other things) not only representations made or sugge…
(a) The representation of a drug, in its labeling, or advertisement, as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as in…
The provisions of this part regarding the selling of food, drugs, devices, or cosmetics, include the manufacture, production, processing, packing, exposure, offer, possession, and holding of any such article for sale; the sale, dispensing, and giving of any such article; and the supplying or applying of any such articl…
The following acts and the causing thereof within the State by any person are prohibited: (1) The manufacture, sale, delivery, holding, or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded; (2) The adulteration or misbranding of any food, drug, device, or cosmetic; (3) The recei…
In addition to the remedies hereinafter provided the department of health may apply to a circuit judge for and the judge shall have jurisdiction upon hearing and for cause shown to grant, a temporary or permanent injunction restraining any person from violating section 328-6, irrespective of whether or not there exists…
(a) Whenever in the judgment of the department of health such action will promote honesty and fair dealing in the interest of consumers, the department shall prescribe regulations fixing and establishing for any food or class of food a reasonable definition and standard of identity, or reasonable standard of quality or…
A food shall be deemed to be adulterated: (1) (A) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but if the substance is not an added substance, the food shall not be considered adulterated under this clause if the quantity of the substance in the food does not o…
A food shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular; or if its labeling or packaging fails to conform with the requirements of sections 328-2 and 328-19.1; (2) If it is offered for sale under the name of another food; (3) If it is an imitation of another food for which…
The director may adopt regulations exempting from any labeling requirement of this part food which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not…
Whenever the department of health finds after investigation that the distribution in the State of any class of food may, by reason of contamination with microorganisms during manufacture, processing, or packing thereof in any locality, be injurious to health, and that the injurious nature cannot be adequately determine…
The department of health may suspend immediately upon notice any permit issued under authority of section 328-11 if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of the permit, and the departmen…
All food shall be prepared, stored, displayed, dispensed, placed, sold, and served so as to be protected from dust, insects, rodents, unnecessary handling, droplet infection, overhead leakage, or other contamination.
The use of latex gloves by personnel in a food establishment permitted under title 11, chapter 50 of the Hawaii administrative rules, shall be prohibited.
(a) Unpackaged processed food, except potentially hazardous food, may be displayed and sold in bulk in self-service containers if all of the following conditions are satisfied: (1) Each self-service container has a tight-fitting lid permanently attached in a manner that prevents the lid from touching the floor, which i…
(a) Any added poisonous or deleterious substance, and food additive, any pesticide chemical in or on a raw agricultural commodity, or any color additive, shall, with respect to any particular use or intended use, be deemed unsafe for the purpose of application of clause (B)(i) of section 328-9(1) with respect to any fo…
A drug or device shall be deemed to be adulterated: (1) (A) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (B) (i) If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered…
A drug or device shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular, or if its labeling or packaging fails to conform with the requirements of section 328-19.1. (2) If in package form, unless it bears a label containing: (A) The name and place of business of the manufacturer,…
(a) A prescription drug shall be dispensed only if its label bears the following: (1) The name, business address, and telephone number of the seller. The business address shall be the physical location of the pharmacy or the dispensing practitioner's office; (2) Except as otherwise authorized for expedited partner ther…
(a) A pharmacy may provide a customized patient medication package to any person; provided that: (1) The pharmacy has obtained the consent of the patient, patient's caregiver, patient's guardian, or prescribing practitioner; provided that the consent may be communicated in writing, orally, or by electronic transmission…
(a) A practitioner or the practitioner's authorized representative shall: (1) Offer to the consumer the option of having the symptom or condition for which a drug is being prescribed listed on the consumer's prescription drug label; and (2) Inform the consumer of the consumer's right to not have the symptom or conditio…
(a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless (1) an application with respect thereto has been approved and the approval has not been withdrawn under section 505 of the Federal Act, or (2) when not subject to the Federal Act, unless the drug has been tested and has b…
Whenever the manufacturer of a drug voluntarily recalls the drug or the Federal Food and Drug Administration or a court orders the recall of a drug, the principal labeler of the drug shall remove the drug from all pharmacies, prescriber offices, medical oxygen distributors, distributors of non-prescription drugs, and h…
(a) An out-of-state practitioner may issue a written, oral, or electronic prescription within the confines of the practitioner's license and in accordance with Hawaii laws and rules. An oral or electronic prescription shall be issued by the out-of-state practitioner or the prescriber's authorized agent and received onl…