reglab/statecodes huggingface dataset:
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-5 Authority and duty of agent; limitations on liability.

§327G-5 Authority and duty of agent; limitations on liability.
(a) The authority of an agent becomes effective only upon a determination that the principal lacks capacity and ceases to be effective upon a determination made under section 327G-7 that the principal has recovered capacity, unless otherwise specified in the advance mental health care directive.
(b) An agent has the authority to make any and all mental health care decisions on behalf of the principal while the principal lacks capacity, unless otherwise specified or limited in the advance mental health care directive.
(c) In exercising authority, an agent has a duty to act consistently with the provisions of the advance mental health care directive. An agent shall make all mental health care decisions in accordance with the principal's preferences or instructions expressed in the advance mental health care directive, if any, and the principal's other wishes to the extent known to the agent. If the principal's preferences, instructions, and wishes are not expressed or known, the agent shall make the decision in accordance with the agent's good faith determination of the principal's best interests. In determining the principal's best interests, the agent shall consider the principal's personal values to the extent known to the agent.
(d) An agent has the same right as the principal to receive information regarding the proposed mental health treatment and to receive, review, and consent to disclosure of medical records relating to that treatment, unless limited by the advance mental health care directive or any federal law. This right of access and disclosure does not waive any evidentiary privilege.
(e) A mental health care decision made by an agent for a principal shall be effective without judicial approval.
(f) An agent is not, solely as a result of acting in that capacity, personally liable for the cost of treatment provided to the principal.
(g) An agent whose decisions regarding the principal are made in good faith, pursuant to the provisions of the advance mental health care directive, shall not be subject to criminal prosecution, civil liability, or professional disciplinary action with respect to those decisions. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-6 Withdrawal of agent; rescission of withdrawal.

§327G-6 Withdrawal of agent; rescission of withdrawal.
(a) An agent may withdraw by giving notice to the principal, if the principal has capacity at the time. If the principal lacks capacity, the agent may withdraw by giving notice to the supervising health care provider or health care institution. The supervising health care provider or health care institution shall promptly record the withdrawal, including the date and time of the withdrawal, in the principal's medical record.
(b) An individual who has withdrawn under subsection (a) may rescind the withdrawal by executing and dating a written acceptance of the designation as agent after the date of the withdrawal. An individual who rescinds a withdrawal shall give notice and a copy of the written acceptance to the principal, if the principal has capacity at the time. If the principal lacks capacity, the individual who rescinds a withdrawal shall give notice and a copy of the written acceptance to the supervising health care provider or health care institution. The supervising health care provider or health care institution shall promptly record the rescission, including the date and time of the rescission, in the principal's medical record and make the written acceptance a part of the principal's medical record. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-7 Presumption of capacity; determination of lack of capacity; recovery of capacity.

§327G-7 Presumption of capacity; determination of lack of capacity; recovery of capacity.
(a) A principal is presumed to have capacity to make mental health care decisions and to execute or revoke an advance mental health care directive or power of attorney designating an agent. Even if the principal has an advance mental health care directive, the principal has the right to make decisions regarding mental health care or mental health treatment, so long as the principal has capacity.
(b) The fact that a principal has executed an advance mental health care directive shall not create a presumption, nor constitute evidence or an indication, that the principal is mentally incompetent or lacks capacity.
(c) This chapter shall not create a presumption concerning the intention of an individual who has not executed or who has revoked an advance mental health care directive or power of attorney.
(d) For the purposes of this chapter, the determination that a principal lacks capacity shall be made by the supervising health care provider who is a physician and one other physician or licensed psychologist after both have conducted an examination of the principal. Upon examination and a joint determination that the principal lacks capacity, the supervising health care provider shall promptly note the determination in the principal's medical record, including the facts and professional opinions that form the basis of the determination, and shall promptly notify the agent that the principal lacks capacity and that the advance mental health care directive has been invoked.
(e) The determination that a principal has recovered capacity shall be made by the supervising health care provider who is a physician. The supervising health care provider shall promptly note the recovery of capacity in the principal's medical record, and shall promptly notify the agent that the principal has recovered capacity. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-8 Limitations on applicability of advance mental health care directive.

§327G-8 Limitations on applicability of advance mental health care directive.
(a) A supervising health care provider, health care provider, or health care institution may subject the principal to mental health treatment in a manner contrary to the principal's preferences and instructions as expressed in an advance mental health care directive only:
(1) When a court order under part 3 of article V of chapter 560 contradicts the principal's preferences and instructions as expressed in the advance mental health care directive; or
(2) In cases of emergency when the principal poses an imminent threat to the safety of self or others.
(b) Neither an advance mental health care directive nor this chapter limits any authority either to take an individual into custody or to admit, retain, or treat an individual in a health care institution pursuant to part IV of chapter 334. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-9 Decisions by guardian.

§327G-9 Decisions by guardian.
(a) A duly appointed guardian for the principal shall comply with the principal's preferences or instructions expressed in the advance mental health care directive and shall not revoke the principal's advance mental health care directive, unless otherwise expressly authorized by a court of competent jurisdiction.
(b) Absent a court order to the contrary, a mental health care decision of an agent takes precedence over that of a guardian.
(c) A mental health care decision made by a guardian for the principal is effective without judicial approval, unless contrary to the principal's preferences or instructions expressed in the advance mental health care directive. [L 2004, c 224, pt of §2; am L 2005, c 22, §16]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-11 Statutory damages.

§327G-11 Statutory damages.
(a) A supervising health care provider or health care institution that intentionally violates this chapter shall be liable to the principal or the principal's estate for damages of $500 or actual damages resulting from the violation, whichever is greater, and reasonable attorney's fees. The damages payable in this section shall be in addition to any other damages permitted by law.
(b) A person who intentionally alters, conceals, obliterates, or falsifies an individual's advance mental health care directive or a revocation of an advance mental health care directive without the individual's consent, or who coerces or fraudulently induces an individual to give, revoke, or not to give an advance mental health care directive, shall be subject to liability to that individual for damages of $2,500 or actual damages resulting from the action, whichever is greater, and reasonable attorney's fees. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-12 Effect of copy.

§327G-12 Effect of copy.
A copy of an advance mental health care directive, revocation of an advance mental health care directive, or designation, revocation, withdrawal, or rescission of withdrawal of an agent has the same effect as the original. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327G. Advance Mental Health Care Directives › 327G-13 Judicial relief.

§327G-13 Judicial relief.
(a) On petition of a principal, the principal's agent or guardian, a health care provider, or a health care institution involved with the principal's care, any court of competent jurisdiction may enjoin or direct a mental health care decision or order other equitable relief. A proceeding under this section shall be governed by part 3 of article V of chapter 560.
(b) Any such petition filed shall include notice of the existence of an advance mental health care directive and a copy of the directive shall be provided to the court. [L 2004, c 224, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 327H. Pain Patient's Bill of Rights › 327H-1 Pain patient's bill of rights; findings.

§327H-1
Pain patient's bill of rights; findings.
The legislature finds that:
(1) Inadequate treatment of severe acute pain and severe chronic pain originating from cancer or noncancerous conditions is a significant health problem;
(2) For some patients, pain management is the single most important treatment a physician can provide;
(3) A patient who suffers from severe acute pain or severe chronic pain should have access to proper treatment of pain;
(4) Due to the complexity of their problems, many patients who suffer from severe acute pain or severe chronic pain may require referral to a physician with expertise in the treatment of severe acute pain and severe chronic pain. In some cases, severe acute pain and severe chronic pain is best treated by a team of clinicians to address the associated physical, psychological, social, and vocational issues;
(5) In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute pain or severe chronic pain can be safe; and
(6) Opiates may be part of an overall treatment plan for a patient in severe acute pain or severe chronic pain who has not obtained relief from any other means of treatment. [L 2004, c 189, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 327K. Provider Orders for Life-Sustaining Treatment › 327K-1 Definitions.

§327K-1 Definitions.
As used in this chapter, unless the context otherwise requires:
"Department" means the department of health.
"Form" means a provider orders for life-sustaining treatment form adopted by the department.
"Health care provider" means an individual licensed, certified, or otherwise authorized or permitted by law to provide health care in the ordinary course of the individual's business or profession.
"Legally authorized representative" means an agent, guardian, or surrogate, as those terms are defined in section 327E-2, or agent designated through a power of attorney for health care, as defined in section 327E-2.
"Patient's provider" means a physician licensed pursuant to chapter 453, a physician assistant licensed pursuant to chapter 453, or an advanced practice registered nurse licensed pursuant to chapter 457 who has examined the patient.
"Provider orders for life-sustaining treatment form" means a form signed by a patient, or if incapacitated, by the patient's legally authorized representative and the patient's provider, that records the patient's wishes and that directs a health care provider regarding the provision of resuscitative and life-sustaining measures. A provider orders for life-sustaining treatment form is not an advance health-care directive. [L 2009, c 186, pt of §1; am L 2014, c 154, §3; am L 2015, c 35, §43; am L 2022, c 293, §4]
2023 Hawaii Revised Statutes › Title 19. Health › 327K. Provider Orders for Life-Sustaining Treatment › 327K-2 Provider orders for life-sustaining treatment form; execution; explanation; compliance; revocation.

§327K-2 Provider orders for life-sustaining treatment form; execution; explanation; compliance; revocation.
(a) The following may execute a form:
(1) The patient;
(2) The patient's provider; and
(3) The legally authorized representative, but only if the patient:
(A) Lacks capacity; or
(B) Has designated that the legally authorized representative is authorized to execute the form.
The patient's provider may medically evaluate the patient and, based upon the evaluation, may recommend new orders consistent with the most current information available about the individual's health status and goals of care. The patient's provider shall consult with the patient or the patient's legally authorized representative before issuing any new orders on a form. The patient or the patient's legally authorized representative may choose to execute or not execute any new form. If a patient is incapacitated, the patient's legally authorized representative shall consult with the patient's provider before requesting the patient's provider to modify treatment orders on the form. To be valid, a form shall be signed by the patient's provider and the patient, or the patient's provider and the patient's legally authorized representative. At any time, a patient, or, if incapacitated, the patient's legally authorized representative, may request alternative treatment that differs from the treatment indicated on the form.
(b) The patient's physician or a health care provider shall explain to the patient the nature and content of the form, including any medical intervention or procedures, and shall also explain the difference between an advance health-care directive and the form. The form shall be prepared by the patient's physician or a health care provider based on the patient's preferences and medical indications.
(c) Any health care provider, including the patient's physician, emergency medical services personnel, and emergency physicians shall comply with a properly executed and signed form and treat the patient according to the orders on the form; provided that compliance shall not be required if the orders on the form request medically ineffective health care or health care that is contrary to generally accepted health care standards.
(d) A patient having capacity, or, if the patient is incapacitated, the patient's legally authorized representative, may revoke a form at any time and in any manner that communicates intent to revoke. [L 2009, c 186, pt of §1; am L 2014, c 154, §4]
2023 Hawaii Revised Statutes › Title 19. Health › 327K. Provider Orders for Life-Sustaining Treatment › 327K-3 Immunity.

§327K-3 Immunity.
(a) No physician, physician assistant, advanced practice registered nurse, health care professional, nurse's aide, hospice provider, home care provider, including private duty and medicare home health providers, emergency medical services provider, adult residential care home operator, skilled nursing facility operator, hospital, or person employed by or under contract with a hospital shall be subject to criminal prosecution, civil liability, or be deemed to have engaged in unprofessional conduct for:
(1) Carrying out in good faith, a decision regarding treatment orders, including cardiopulmonary resuscitation by or on behalf of a patient pursuant to orders in a form and in compliance with the standards and procedures set forth in this chapter; or
(2) Providing cardiopulmonary resuscitation to a patient for whom an order not to resuscitate has been issued on a form; provided that the person reasonably and in good faith:
(A) Was unaware of the issuance of an order not to resuscitate; or
(B) Believed that any consent to treatment orders, including the order not to resuscitate, had been revoked or canceled.
(b) No person shall be subject to criminal prosecution or civil liability for consenting or declining to consent, in good faith and on behalf of a patient, to the issuance of an order not to resuscitate pursuant to this chapter. [L 2009, c 186, pt of §1; am L 2014, c 154, §5; am L 2022, c 293, §5]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-2 Same; label, etc.

§328-2 Same; label, etc.
"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 information also appears on the outside container or wrapper, if any there be, of the retail package of the article, or is easily legible through the outside container or wrapper.
"Immediate container" does not include package liners.
"Labeling" means all labels and other written, printed, or graphic matter (1) upon an article or any of its containers or wrappers, or (2) accompanying the article.
"Package" means any container or wrapping in which any consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers, but does not include (1) shipping containers or wrappings used solely for the transportation of any consumer commodity in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors thereof; (2) shipping containers or outer wrappings used by retailers to ship or deliver any commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity.
"Principal display panel" means that part, or those parts, of a package or label that is, or are, so designed as to most likely be displayed, presented, shown or examined under normal and customary conditions of display and purchase.
Whenever the principal display panel of the package is not coincident with the principal display panel of the label, the principal display panel of the package shall govern the declaration of quantity type size and the principal display panel of the label shall govern its location.
Whenever a difference of opinion exists as to which panel of a package constitutes the principal display panel, the larger panel most likely to be displayed shall be so construed.
Whenever a consumer package has more than one principal display panel, each such panel shall bear all mandatory information required by this part and by the Federal Act.
"Principal labeler" means the manufacturer, packer, or distributor whose name is on the package which contains the finished drug and is distributed to the dispenser. If more than one name is on the package, the principal labeler shall be the manufacturer, packer, or distributor whose name is on the package and who had possession of the package immediately before the dispenser of the drug. [L 1941, c 318, pt of §2; RL 1945, §2202; RL 1955, §51-2; HRS §328-2; am L 1972, c 151, pt of §2; am L 1977, c 58, §43; am L 1982, c 122, §1(2)]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-3 Same; misbranding or misleading advertisement.

§328-3 Same; misbranding or misleading advertisement.
(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 suggested by statement, word, design, device, sound, or in any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of the representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.
(b) "Advertisement" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics. [L 1941, c 318, pt of §2; RL 1945, §2203; RL 1955, §51-3; HRS §328-3]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-4 Same; antiseptic, germicide; new drug; contamination.

§328-4 Same; antiseptic, germicide; new drug; contamination.
(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 involves prolonged contact with the body.
(b) "New drug" means (1) any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
(c) "Contaminated with filth" applies to any food, drug, device, or cosmetic not securely protected from dust, dirt, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations. [L 1941, c 318, pt of §2; RL 1945, §2204; RL 1955, §51-4; am L 1967, c 152, §2; HRS §328-4]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-5 Same; "selling" includes what.

§328-5 Same; "selling" includes what.
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 article in the conduct of any food, drug, or cosmetic establishment. [L 1941, c 318, pt of §2; RL 1945, §2205; RL 1955, §51-5; HRS §328-5]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-7 Remedies for violation of law.

§328-7 Remedies for violation of law.
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 any other remedy. [L 1941, c 318, §4; RL 1945, §2207; RL 1955, §51-7; am L Sp 1959 2d, c 1, §19; HRS §328-7]
Rules of Court
Injunctions, see HRCP rule 65.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-8 Regulations to be prescribed.

§328-8 Regulations to be prescribed.
(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 fill of container. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the department shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. The definitions and standards so prescribed shall conform so far as practicable to the definitions and standards promulgated under authority of the Federal Act.
(b) Temporary permits now or hereafter granted for interstate shipment of experimental packs of food varying from the requirements of federal definitions and standards of identity are automatically effective in this State under the conditions provided in such permits. In addition, the director may issue additional permits where they are necessary to the completion or conclusiveness of an otherwise adequate investigation and where the interests of consumers are safeguarded. Such permits shall be subject to such terms and conditions as the director may prescribe.
(c) The director may establish rules as necessary for the enforcement of this part. The rules shall be adopted pursuant to chapter 91; except that the director may, without regard to chapter 91, establish tolerance levels and regulatory or action levels by reference to the provisions of the regulations or guidelines of the United States established in 40 Code of Federal Regulations Parts 180 and 185 or the United States Food and Drug Administration Compliance Policy Guides as the regulations or guidelines become effective at any time or from time to time. [L 1941, c 318, §5; RL 1945, §2208; RL 1955, §51-8; am L Sp 1959 2d, c 1, §19; HRS §328-8; am L 1972, c 151, §4; am L 1977, c 200, §2; am L 1983, c 100, §5; am L 1984, c 12, §2; am L 1985, c 144, §1; am L 1989, c 72, §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-10.5 Regulations for exemption from labeling requirements.

§328-10.5 Regulations for exemption from labeling requirements.
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 adulterated or misbranded under the provisions of this part upon removal from such processing, labeling or repacking establishment. [L 1972, c 151, §6]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-11 Regulations to prevent contamination; emergency permits to manufacturers, processors and packers.

§328-11 Regulations to prevent contamination; emergency permits to manufacturers, processors and packers.
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 determined after such articles have entered commerce, it then, and in such case only, shall prescribe regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in the locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health. After the effective date of the regulations, and during the temporary period, no person shall introduce or deliver for introduction into commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless the manufacturer, processor, or packer holds a permit issued by the department as provided by such regulations. [L 1941, c 318, pt of §8; RL 1945, §2211; RL 1955, §51-11; am L Sp 1959 2d, c 1, §19; HRS §328-11]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-12 Suspension and reinstatement of permits.

§328-12 Suspension and reinstatement of permits.
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 department shall, immediately after prompt hearing and an inspection of the establishment, reinstate the permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued, or as amended.
Any officer or employee duly designated by the director of health shall have access to any factory or establishment, the operator of which holds a permit from the department, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be grounds for suspension of the permit until such access is freely given by the operator. [L 1941, c 318, pt of §8; RL 1945, §2212; RL 1955, §51-12; am L Sp 1959 2d, c 1, §19; HRS §328-12]
Cross References
Other food safety issues, see § §321-4.5, 321-4.6, 321-11.51, and 321-27.5.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-12.3 Protection of food.

§328-12.3 Protection of food.
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. [L 1983, c 150, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-12.4 Food establishments; use of latex gloves prohibited.

§328-12.4 Food establishments; use of latex gloves prohibited.
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. [L 2016, c 180, §4]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-12.7 Display of unpackaged processed food.

§328-12.7 Display of unpackaged processed food.
(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 is kept in a closed position at all times except during customer service;
(2) Each self-service container has a utensil with a handle for dispensing the food;
(3) Self-service containers, lids, and utensils are constructed of nontoxic materials and provide for easy cleaning and repair;
(4) Self-service containers, lids, and utensils are maintained in a sanitary condition and in a manner that prevents spoilage and infestation;
(5) A sign is posted prominently and conspicuously within the immediate display area directing customers to utilize the utensils provided when serving themselves; and
(6) A label is conspicuously displayed in plain view of the customer and securely attached to each self-service container or in a clear relationship thereto, which contains the following:
(A) Common name of product; and
(B) Declaration of each ingredient used in the manufacture by their common or usual name in descending order of predominate weight. This declaration shall be provided in writing to the food establishment by the manufacturer, packer, or distributor.
(b) Unpackaged processed food may be displayed and sold in bulk in other than self-service containers if all of the following conditions are satisfied:
(1) The food is served by an employee of the food establishment directly to a consumer; and
(2) The food is displayed in clean, sanitary, and covered or otherwise protected containers.
(c) If the director makes a specific finding that a disease is actually transmitted by the method of dispensing unpackaged processed food, as prescribed by this section, the director may establish by rule greater restrictions on the sale of such food than are required by this section. Such rule shall bear directly on the specific relationship between the disease actually transmitted and the dispensing methods permitted by this section. [L 1983, c 150, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-14 Drugs or devices deemed adulterated when.

§328-14 Drugs or devices deemed adulterated when.
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 injurious to health; or
(ii) If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess; or
(C) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(D) If:
(i) It bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the Federal Act; or
(ii) It is a color additive, the intended use of which is for purposes of coloring only, and is unsafe within the meaning of the Federal Act;
(2) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium. Such a determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of these tests or methods of assay, those prescribed under authority of the Federal Act. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in the compendium, if its difference in strength, quality, or purity from that standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States and not those of the United States Pharmacopoeia;
(3) If it is not subject to paragraph (2) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;
(4) If it is a drug and any substance has been (A) mixed or packed therewith so as to reduce its quality or strength; or (B) substituted wholly or in part therefor. [L 1941, c 318, §10; RL 1945, §2214; RL 1955, §51-14; am L 1967, c 152, §8; HRS §328-14; am L 1995, c 6, §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-16.2 Customized patient medication package.

§328-16.2 Customized patient medication package.
(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; provided further that the format of the consent shall be identified on the prescription record required to be maintained under section 328-17.7;
(2) The consent is accompanied by the patient's current prescription; and
(3) The customized patient medication package meets the requirements of section 328-16.
(b) As used in this section, "customized patient medication package" means a package that is prepared by a pharmacist for a specific patient and contains one or more prescribed solid oral dosage forms. [L 2020, c 27, §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-16.5 Prescription labeling.

§328-16.5 Prescription labeling.
(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 condition listed on the prescription drug label.
(b) The symptom or condition shall not appear on the prescription drug label if the consumer refuses.
(c) Instructions for including the symptom or condition on the consumer's prescription drug label shall be written by the practitioner on the prescription.
(d) The symptom or condition shall be printed on the prescription drug label only if it is written on the prescription as part of the directions for use. Any symptom or condition written on a prescription that is not part of the directions for use shall not be printed on the prescription drug label. [L 1995, c 206, §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-17.5 Principal labeler responsibility under recall of drug.

§328-17.5 Principal labeler responsibility under recall of drug.
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 health care facilities. [L 1982, c 122, §1(1); am L 2000, c 83, §3]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-17.7 Record of prescriptions.

§328-17.7 Record of prescriptions.
(a) Every practitioner, pharmacist, or medical oxygen distributor who compounds, sells, or delivers any prescribed drug to a patient or a patient's agent shall maintain records that identify:
(1) The specific drug product dispensed, including:
(A) The product's national drug code (NDC) number; or
(B) The brand name or the established name and the name or commonly accepted abbreviation of the principal labeler of the drug product dispensed, the product strength, and the dosage form;
(2) The quantity of the drug;
(3) Directions for use;
(4) The number of allowable refills;
(5) The date of initial dispensing and the dates of all refilling;
(6) The date of any transfer of the prescription;
(7) The name, business address, and telephone number of the recipient pharmacist or medical oxygen distributor for any transfer of prescription;
(8) The prescribing practitioner, including name, business address, and telephone number;
(9) The format (oral, written, or electronic) in which the prescription was received;
(10) Except as otherwise authorized for expedited partner therapy in section 453-52 or for an opioid antagonist in section 461-11.8, the patient, including name, address, and telephone number;
(11) The date of prescribing; and
(12) The name of the practitioner, pharmacist, or medical oxygen distributor dispensing the drug.
Every prescription dispensed shall have the name of the pharmacist, dispensing practitioner, or medical oxygen distributor responsible for the dispensing appended to the prescription record, and every prescription record shall be preserved and legible for a period of not less than five years. The prescription records shall be subject at all times to the inspection of the director of health or the director's agent.
(b) Prescription records may be electronically maintained using an appropriate prescription information processing system; provided that:
(1) There are procedures to maintain the records, including but not limited to auxiliary procedures for backing up files, computer downtime, and the protection of patient confidentiality; and
(2) Upon request the prescription records, or a subset thereof, shall be provided to the director or the director's agent, in a form specified by the director, within forty-eight hours.
(c) Prescription records shall be maintained electronically or manually such that the information is readily retrievable during the pharmacy's normal operating hours. [L 1992, c 177, pt of §1; am L 1997, c 214, §5; am L 2000, c 83, §5; am L 2001, c 124, §5; am L 2003, c 56, §4; am L 2013, c 250, §6; am L 2018, c 154, §6]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-17.8 Electronic prescription information.

§328-17.8 Electronic prescription information.
(a) Prescription information may be transmitted electronically; provided that:
(1) The information shall be communicated only between the prescribing practitioner or the prescriber's authorized agent and pharmacies or medical oxygen distributors of the patient's choice;
(2) The information shall be communicated in a retrievable, recognizable format acceptable to the intended recipient;
(3) No electronic system, software, or other intervening mechanism or party shall alter the practitioner's prescription, order entry, selection, or intended selection without the practitioner's approval, on a per prescription or per order basis. Transmitted prescription information shall not be altered by any system, software, or other intervening mechanism or party prior to receipt by the intended pharmacy or medical oxygen distributor recipient;
(4) The prescription information processing system shall provide for adequate confidentiality safeguards provided by any applicable federal or state law; and
(5) Practitioners, pharmacists, and medical oxygen distributors shall exercise prudent and professional judgment regarding the accuracy, validity, and authenticity of any prescription information communicated, received, or transferred.
(b) Nothing in this section shall be construed or interpreted to prevent the transmission of health care information, including prescription information, between health plans and their authorized agents and prescribing practitioners, pharmacists, and medical oxygen distributors for the purpose of the adjudication or payment of claims. [L 2001, c 124, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-17.9 Supply of electronic equipment. No person shall supply prescription information processing system equipment, including computer hardware, software, facsimile machines, and related equipment, to practitioners, pharmacists, pharmacies, or medical oxygen distributors, on the condition, agreement, or understanding that the recipient of the equipment shall not deal in the commodity of a competitor, shall not deal with a competitor, or shall deal only with persons identified by the supplier of the equipment. [L 2001, c 124, pt of §1]

§328-17.9
Supply of electronic equipment.
No person shall supply prescription information processing system equipment, including computer hardware, software, facsimile machines, and related equipment, to practitioners, pharmacists, pharmacies, or medical oxygen distributors, on the condition, agreement, or understanding that the recipient of the equipment shall not deal in the commodity of a competitor, shall not deal with a competitor, or shall deal only with persons identified by the supplier of the equipment. [L 2001, c 124, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-18 Cosmetics deemed adulterated when.

§328-18 Cosmetics deemed adulterated when.
A cosmetic shall be deemed to be adulterated:
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual; provided that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution--This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness", and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (5) the term "hair dye" shall not include eyelash dyes or eyebrow dyes;
(2) If it consists in whole or in part of any filthy, putrid, or decomposed substance;
(3) If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(4) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(5) If it is not a hair dye and it is or bears or contains a color additive which is unsafe within the meaning of the Federal Act. [L 1941, c 318, §13; RL 1945, §2217; RL 1955, §51-17; am L 1967, c 152, §12; HRS §328-18]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-19 Cosmetics deemed misbranded when.

§328-19 Cosmetics deemed misbranded when.
A cosmetic 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 of this part;
(2) If in package form, unless it bears a label containing (A) the name and place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label; provided that under clause (B) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the director;
(3) If any word, statement, or other information required by or under authority of this part to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) If its container is so made, formed or filled as to be misleading;
(5) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to the color additive prescribed under the Federal Act. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 328-18(1));
(6) Unless it is a cosmetic which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed. Such cosmetic is exempted from the affirmative labeling requirements of this part while it is in transit in commerce from the one establishment to the other, if such transit is made in good faith for such completion purposes only; but it is otherwise subject to all applicable provisions of this part. [L 1941, c 318, §14; RL 1945, §2218; RL 1955, §51-18; am L 1967, c 152, §13; HRS §328-19; am L 1972, c 151, §11]
Case Notes
See 315 U.S. 257 (1942); 11 F.2d 399 (1926).