reglab/housing_qa huggingface dataset:
HI Rev Stat § 328-8 (2021)
2021 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]
HI Rev Stat § 328-10.5 (2021)
2021 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]
HI Rev Stat § 328-11 (2021)
2021 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]
HI Rev Stat § 328-12 (2021)
2021 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, 4.6, 11.51, and 27.5.
HI Rev Stat § 328-12.3 (2021)
2021 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]
HI Rev Stat § 328-12.4 (2021)
2021 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]
HI Rev Stat § 328-12.7 (2021)
2021 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]
HI Rev Stat § 328-14 (2021)
2021 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]
HI Rev Stat § 328-16.2 (2021)
2021 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]
HI Rev Stat § 328-16.5 (2021)
2021 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]
HI Rev Stat § 328-17.5 (2021)
2021 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]
HI Rev Stat § 328-17.7 (2021)
2021 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]
HI Rev Stat § 328-17.8 (2021)
2021 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]
HI Rev Stat § 328-17.9 (2021)
2021 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]
HI Rev Stat § 328-18 (2021)
2021 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]