reglab/statecodes huggingface dataset:
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-20 False advertising; exceptions.

§328-20 False advertising; exceptions.
(a) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular.
(b) For the purpose of this part the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or venereal disease shall also be deemed to be false, except that no advertisement not in violation of subsection (a) shall be deemed to be false under this subsection if it is disseminated only to members of the medical, osteopathic, podiatric, dental, or veterinary professions, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs or devices; provided that whenever the department determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, the department shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the department may deem necessary in the interest of public health; provided that this subsection shall not be construed as indicating that self-medication for diseases other than those named herein is safe or efficacious. [L 1941, c 318, §15; RL 1945, §2219; RL 1955, §51-19; am L Sp 1959 2d, c 1, §19; am L 1964, c 15, §2; HRS §328-20]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-21 Rules and regulations, hearings.

§328-21 Rules and regulations, hearings.
(a) Subject to chapter 91 the director of health may adopt and enforce such rules or regulations as the director may deem necessary for the efficient enforcement of this part. The director may make the rules or regulations prescribed under this part conform insofar as practicable with those promulgated under the Federal Act.
(b) Hearings authorized or required by this part shall be conducted by the director or any officer, agent, or employee designated by the director for that purpose and shall be subject to chapter 91. [L 1941, c 318, §16; RL 1945, §2220; RL 1955, §51-20; am L 1965, c 96, §37; HRS §328-21; gen ch 1985]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-22 Duties of department.

§328-22 Duties of department.
The department of health shall inquire carefully into the quality of any food, drug, device, or cosmetic manufactured, sold, or kept or exhibited or offered for sale by any person; and it may in a lawful manner procure samples thereof, submit the same to careful examination and report the result of such analysis of all or any such food, drugs, devices, or cosmetics as are adulterated, impure, or unwholesome, in contravention of the laws of the State, to the director; and the director shall make complaint with the necessary evidence through the proper authorities, against such person; provided that nothing in this part shall require the department to report for the institution of proceedings under this part, minor violations of this part, whenever it believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning; provided further that whenever the department believes that the public interest will be adequately served by the issuance of a warning to the general public by virtue of the degree of adulteration, impurity, or unwholesomeness in contravention of the laws of the State present in any food, drugs, devices, or cosmetics which constitute a hazardous condition, it shall issue a warning through all available news media including television, radio, newspaper, and other available methods of communication. When the hazardous condition has been corrected, the department shall issue a statement to be made through all available news media that conditions as corrected have returned to a safe and normal level.
The department shall investigate complaints on the information of any person who lays before it satisfactory evidence of the same. [L 1941, c 318, §18; RL 1945, §2222; RL 1955, §51-22; am L Sp 1959 2d, c 1, §19; HRS §328-22; am L 1973, c 34, §1; gen ch 1985]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-23 Inspection powers of director.

§328-23 Inspection powers of director.
The director of health or any of the director's agents are authorized upon presenting appropriate credentials to the owner, operator or agent in charge, (1) to enter at all reasonable hours any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in commerce; (2) to inspect at reasonable times and within reasonable limits and in a reasonable manner such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers and labeling therein to determine if this part is being violated; (3) to have access to and to copy all records of carriers in commerce showing the movement in commerce of any food, drug, device, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper and consignee thereof; provided that evidence obtained under this subsection shall not be used in a criminal prosecution of the person from whom obtained; and provided further that carriers shall not be subject to the other provisions of this part by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, or cosmetics in the usual course of business as carriers; and (4) to secure samples or specimens of any food, drug, device, or cosmetic after paying or offering to pay for the sample. The director shall make or cause to be made examinations of samples secured under this section to determine whether or not this part is being violated. [L 1941, c 318, §20; RL 1945, §2224; RL 1955, §51-24; am L Sp 1959 2d, c 1, §19; HRS §328-23; am L 1972, c 151, §13; gen ch 1985]
Rules of Court
Injunctions, see HRCP rule 65.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-24 Furnishing of samples to director.

§328-24 Furnishing of samples to director.
(a) If any person manufacturing, keeping for sale, exhibiting for sale, or offering for sale any food, drug, device, or cosmetic included in this part refuses to furnish the duly appointed director of health or any of the director's agents, upon demand, either personal or in writing, a sample sufficient for the analysis of the food, drug, device, or cosmetic, which is in the person's possession, such refusal shall be prima facie evidence that the food, drug, device, or cosmetic so manufactured, kept for sale, exhibited for sale, or offered for sale is adulterated within the meaning of this part.
(b) A sample of any product covered under this section that is known to be or suspected of being contaminated shall be furnished upon request to the director or any of the director's agents at no cost to the department.
The director or agent securing a sample under this section from any retailer or wholesaler or any person other than the manufacturer shall, prior to leaving the premises, provide the establishment with a receipt describing the sample obtained. The receipt may be used for reimbursement from the appropriate supplier or manufacturer. [L 1941, c 318, §21; RL 1945, §2225; RL 1955, §51-25; am L Sp 1959 2d, c 1, §19; HRS §328-24; am L 1985, c 144, §2; gen ch 1985]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-26 Disposal of questioned articles; court orders; expenses; bond.

§328-26 Disposal of questioned articles; court orders; expenses; bond.
If the court finds that a detained or embargoed article is adulterated or misbranded, the article shall, after entry of the decree be destroyed at the expense of the claimant thereof, under the supervision of the director of health or any of the director's deputies; and all court costs and fees, and storage and other proper expenses, shall be taxed against the claimant of the article or the claimant's agent; provided that when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court, after entry of the decree and after such costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that the article shall be so labeled or processed, has been executed, may by order direct that the article be delivered to the claimant thereof for such labeling or processing under the supervision of the director or any of the director's agents. The expense of supervision shall be paid by the claimant. The bond shall be returned to the claimant of the article on representation to the court by the director or any of the director's agents that the article is no longer in violation of this part, and that the expenses of supervision have been paid. [L 1941, c 318, pt of §22; RL 1945, §2227; RL 1955, §51-27; am L Sp 1959 2d, c 1, §19; HRS §328-26; gen ch 1985]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-27 Perishables destroyed when.

§328-27 Perishables destroyed when.
Whenever the director of health or any of the director's agents find in any room, building, vehicle of transportation, or other structure, any meat, seafood, poultry, vegetable, fruit, or other perishable articles which are unsound, or contain any filthy, decomposed, or putrid substance, or that may be poisonous or deleterious to health or otherwise unsafe, the same being hereby declared to be a nuisance, the director or any of the director's agents, shall forthwith condemn or destroy the same, or in any other manner render the same unsalable as human food. [L 1941, c 318, pt of §22; RL 1945, §2228; RL 1955, §51-28; am L Sp 1959 2d, c 1, §19; HRS §328-27; gen ch 1985]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-28 Duties of county attorneys, prosecuting attorney.

§328-28 Duties of county attorneys, prosecuting attorney.
Each county attorney, or prosecuting attorney to whom the department of health reports any violation of this part, shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law. Before any violation of this part is reported to any such attorney for the institution of a criminal proceeding, the person against whom the proceeding is contemplated shall be given appropriate notice and an opportunity to present the person's views before the department either orally or in writing, in person or by attorney, with regard to such contemplated proceeding. [L 1941, c 318, §24; RL 1945, §2230; RL 1955, §51-29; am L Sp 1959 2d, c 1, §19; HRS §328-28; gen ch 1985]
Revision Note
Reference to "prosecuting attorney of the city and county of Honolulu" deleted as unnecessary.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-29 Penalty; exceptions.

§328-29 Penalty; exceptions.
(a) Any person who violates section 328-6 shall be fined not more than $500, or imprisoned not more than one year, or both.
(b) No person shall be subject to the penalties of subsection (a) of this section, for having violated section 328-6(1) or (3) if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the State from whom he received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this part, designating this part.
(c) No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by him of such false advertisement, unless he has refused on the request of the department of health to furnish the department the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency residing in the State who caused him to disseminate such advertisement. [L 1941, c 318, §25; RL 1945, §2231; am L 1953, c 110, §1; RL 1955, §51-30; am L Sp 1959 2d, c 1, §19; HRS §328-29]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-30 Administrative penalties.

§328-30 Administrative penalties.
(a) Any person who violates this part or any rule adopted by the department pursuant to this part shall be fined not more than $10,000 for each separate offense. Any action taken to collect the penalty provided for in this subsection shall be considered a civil action.
(b) In addition to any other administrative or judicial remedy provided by this part, or by rules adopted pursuant to this part, the director may impose by order the administrative penalty specified in this section. Factors to be considered in imposing the administrative penalty include the nature and history of the violation and of any prior violation, and the opportunity, difficulty, and history of corrective action. For any judicial proceeding to recover the administrative penalty imposed, the director need only show that notice was given, a hearing was held or the time granted for requesting a hearing has expired without such a request, the administrative penalty was imposed, and that the penalty remains unpaid. [L 1983, c 100, pt of §2; am L 1984, c 12, §4]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-31 Injunctive relief.

§328-31 Injunctive relief.
The director may institute a civil action in any court of competent jurisdiction for injunctive relief to prevent any violation of this part or any rule adopted to implement this part. The court shall have powers to grant relief in accordance with the Hawaii rules of civil procedure. [L 1983, c 100, pt of §2]
Rules of Court
Injunctions, see HRCP rule 65.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-41 Definitions.

§328-41 Definitions.
"Cold storage" as used in sections 328-41 to 328-48 means a place artificially cooled to a temperature of forty degrees Fahrenheit or below but does not include such a place in a private home, hotel, restaurant, or exclusively retail establishment not storing articles of food for other persons. "Cold stored" as used in such sections means the keeping of articles of food in cold storage for a period exceeding thirty days from the date of placing them in any cold storage or refrigerating warehouse. "Storer" means the person who offers articles of food for cold storage. "Operator" means any person operating a cold storage. [L 1925, c 194, §1; RL 1935, §1063; RL 1945, §2232; RL 1955, §51-40; HRS §328-41]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-42 Department of health regulations.

§328-42 Department of health regulations.
Every cold storage or refrigerating warehouse wherein are stored articles of food, shall be properly located, constructed, equipped for the business of cold storage, and kept in a sanitary condition as prescribed by the department of health regulations. [L 1925, c 194, §2; RL 1935, §1064; RL 1945, §2233; RL 1955, §51-41; am L Sp 1959 2d, c 1, §19; HRS §328-42]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-43 Records, food to be marked.

§328-43 Records, food to be marked.
Every operator or storer shall keep an accurate record of the receipts and the withdrawals with reference to cold storage of all articles of food within the operator's possession and control. Every operator shall also keep an accurate record of storers having exclusive possession of a portion of the operator's or storer's cold storage.
All articles of food when deposited in cold storage shall be marked plainly on or in connection with the containers in which they are packed or on the individual article, with the date of receipt, and, when removed from cold storage, shall be marked with the date of withdrawal, in accordance with such forms as may be prescribed by the department of health.
The department shall have free access to these records at any time. [L 1925, c 194, § §3, 5; RL 1935, §1065; RL 1945, §2234; RL 1955, §51-42; am L Sp 1959 2d, c 1, §19; HRS §328-43; gen ch 1985]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-44 Bad food; bait.

§328-44 Bad food; bait.
No storer or operator shall place in cold storage any article of food if diseased, tainted, or deteriorated so as to injure its keeping qualities or if not properly slaughtered, handled, and prepared for storage; provided that this section shall not apply to bait to be used for fishing purposes. All such bait shall be stored in rooms specially set aside for such purposes. [L 1925, c 194, §4; RL 1935, §1066; RL 1945, §2235; RL 1955, §51-43; HRS §328-44]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-45 Length of storage time.

§328-45 Length of storage time.
No person having control as storer shall keep in cold storage any articles of food for a longer period than twelve calendar months, except with the consent of the department of health, as hereinafter provided. The department shall, upon application, grant permission to extend the period of storage beyond twelve months for a particular consignment of goods, if the goods in question are found, upon examination, to be in proper condition for further storage at the end of twelve months. The length of time for which storage is allowed shall be specified in the order granting permission. [L 1925, c 194, §6; RL 1935, §1067; RL 1945, §2236; RL 1955, §51-44; am L Sp 1959 2d, c 1, §19; HRS §328-45]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-46 Restorage prohibited.

§328-46 Restorage prohibited.
It shall be unlawful for any storer or operator to return to cold storage any article of food that has once been released from such storage and placed on the market for sale to consumers, but nothing in this section shall prevent the transfer of goods from one cold storage or refrigerating warehouse to another; provided that such transfer is not made for the purpose of evading sections 328-41 to 328-47. [L 1925, c 194, §7; RL 1935, §1068; RL 1945, §2237; RL 1955, §51-45; HRS §328-46]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-47 Cold stored goods to be labeled; sales of.

§328-47 Cold stored goods to be labeled; sales of.
It shall be unlawful to sell or to offer for sale uncooked articles of food, which have been cold stored without notifying persons purchasing, or intending to purchase, the same that they have been kept in cold storage by the display, in a conspicuous place and upon the articles of food, of a sign marked, "These are cold stored goods", in large, plain type; and it shall be unlawful to represent or advertise as fresh goods, articles of food which have been placed in cold storage. [L 1925, c 194, §8; RL 1935, §1069; RL 1945, §2238; RL 1955, §51-46; HRS §328-47]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-48 Penalty.

§328-48 Penalty.
Any person violating any of the provisions of sections 328-41 to 328-47 shall be fined not less than $10 nor more than $200 for each offense. [L 1925, c 194, §9; RL 1935, §1070; RL 1945, §2239; RL 1955, §51-47; HRS §328-48]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-49 What fish and when same may be put in cold storage for future sale.

§328-49 What fish and when same may be put in cold storage for future sale.
All catches of the following food fishes, such as weke, ahuluhulu, kumu, uhu, opelu, oama, manini, moi, amaama, papiopio, ulua, awa, akule, oio, nehu, maomao, iao, omaka, lauhau, laenihi, puhikii, akilolo, hahalalu, iheihe, opae, piha, laipala, aholehole, uiui, malolo, kole, paoo, puhi, auau, ohua aliko, ohua palemo, alaihi, upapalu, uu, ahaaha, puili, alalauwa, aweoweo, maikoiko, kala, aloiloi, maiii, aalaheo, pakii, oopu nopili, oopu nakea, mamamo, oopukai, hinalea, hinana, goldfish, catfish, and mudfish, and all other smaller fishes of any species caught after twelve o'clock noon of any calendar day, shall be marketed as soon as brought to shore. Any fishes which cannot be marketed or which remain unsold in the market at the close of the market in the evening may be placed in cold storage or ice house for future sale; provided that no fishes shall be so placed in cold storage which have been caught more than twelve hours, unless the fishes were artificially chilled as soon as caught, or which have been bruised, torn or otherwise rendered liable to spoil. [L 1921, c 38, §1; RL 1925, §4260; RL 1935, §1071; RL 1945, §2240; RL 1955, §51-48; HRS §328-49]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-50 Fishing on commercial fishing vessels.

§328-50 Fishing on commercial fishing vessels.
Anything in the statute or rules and regulations to the contrary notwithstanding, fish caught and immediately placed on ice or otherwise adequately chilled on commercial fishing vessels may be sold upon their return to port. Any fish remaining unsold shall be placed in cold storage and may be later sold at any time thereafter as long as the fish are not spoiled and unfit for human consumption. [L 1947, c 187, §1; RL 1955, §51-49; HRS §328-50]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-51 Causing preventable deterioration of; penalty.

§328-51 Causing preventable deterioration of; penalty.
Any person who by interference, intimidation, or carelessness, causes or permits preventable deterioration or waste in connection with the marketing of such fishes or their preservation, or who prevents or attempts to prevent lawful cold storage of such fishes, shall be fined not more than $200, or imprisoned not more than three months, or both. [L 1921, c 38, §2; RL 1925, §4261; RL 1935, §1072; RL 1945, §2241; RL 1955, §51-50; HRS §328-51]
Cross References
Classification of offense and authorized punishment, see § §701-107, 706-640, and 706-663.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-61 Notifying consumer.

§328-61 Notifying consumer.
No person shall sell or offer to sell any uncooked thawed food which substantially resembles the physical appearances of the fresh food without a label, as hereinafter described, notifying the purchaser that such food had been frozen and then thawed out; provided that this section shall not apply if the thawed foods are processed by grinding or have been dehydrated before being offered for retail sale. [L 1967, c 206, pt of §1; HRS §328-61; am L 1980, c 40, §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-62 Description of label.

§328-62 Description of label.
"Label" means the information required in this part to be placed on any food products by means of a stamp, stencil, or printing by machine, or by attaching to the immediate package, by sign, handbill, placard, or otherwise, the words "PREVIOUSLY FROZEN" in letter size easily seen under customary conditions of purchase. [L 1967, c 206, pt of §1; HRS §328-62; am L 1980, c 40, §3]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-63 Injunction.

§328-63 Injunction.
Any violations of this part may be enjoined or abated in a suit filed and prosecuted in the circuit court of the State by the department of health. [L 1967, c 206, pt of §1; HRS §328-63]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-64 Offense, penalty.

§328-64 Offense, penalty.
Each day that this part is violated shall be a separate offense. Any person, firm, partnership, or corporation who violates this part shall be fined not more than $500. [L 1967, c 206, pt of §1; HRS §328-64]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-71 Definitions.

§328-71 Definitions.
When used in sections 328-71 to 328-76, unless the context otherwise requires:
"Department" means the department of health.
"Enriched" as applied to flour means the addition to flour of the vitamins and other nutritional ingredients necessary to make it conform to the definition and standard of identity of enriched flour, or enriched bromated flour or enriched self-rising flour, as the case may be, promulgated by the Federal Food and Drug Administration (21 C.F.R. Part 137), or as the same may be from time to time amended or modified.
"Flour" is limited to the foods defined as (A) flour, white flour, wheat flour, plain flour, (B) bromated flour, (C) self-rising flour, self-rising white flour, self-rising wheat flour, and (D) phosphated flour, phosphated white flour, and phosphated wheat flour, in the definitions and standards of identity promulgated by the Federal Food and Drug Administration (21 C.F.R. Part 137), or as they may be amended, but does not include special flours not used for bread, roll, bun, or biscuit baking, such as specialty cake, pancake, and pastry flours.
"Person" means an individual, a corporation, a partnership, an association, a joint stock company, a trust, or an unincorporated organization to the extent engaged in the commercial manufacture or sale of flour, white bread or rolls.
"Rolls" includes plain white rolls and buns of the semi-bread dough type, such as soft rolls, hamburger, hot dog, Parker House, etc., hard rolls, such as Vienna, Kaiser, etc., all made without fillings or icings, but shall not include yeast-raised sweet rolls or sweet buns, cinnamon rolls or buns, butterfly rolls, etc.
"White bread" means any bread, whether baked in a pan or on a hearth or screen, which is commonly known or usually represented and sold as white bread, including, but not restricted to, Vienna bread, French bread, and Italian bread. [L 1945, c 101, §1; RL 1945, §2246.01; RL 1955, §51-55; am L Sp 1959 2d, c 1, §19; HRS §328-71; am L 1977, c 53, §1]
Revision Note
Numeric designations deleted and definitions rearranged.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-72 Flour must be enriched.

§328-72 Flour must be enriched.
It shall be unlawful for any person to manufacture, mix, compound, sell, or offer for sale in this State for human consumption therein, any unenriched flour; provided that unenriched flour may be used in the manufacture of macaroni, cracker, soy sauce, or other nonbaking products; provided further that unenriched flour may be sold to commercial bakers of bread, rolls, or buns if, prior to or simultaneously with delivery, the baker furnishes to the seller a certificate of intent in such form as the department of health shall by regulation prescribe, certifying that such flour will be used only in the manufacture, mixing, or compounding of flour or white bread or rolls enriched to meet the requirements of sections 328-71 to 328-76. It shall be unlawful for the baker to use the flour so purchased in any manner other than as stated in the certificate. [L 1945, c 101, §2; RL 1955, §51-56; am L 1963, c 105, §1; HRS §328-72]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-73 Bread, rolls, buns, standard for.

§328-73 Bread, rolls, buns, standard for.
It shall be unlawful for any person to manufacture, bake, sell, or offer for sale, in this State, for human consumption therein, any white bread or rolls unless the same conforms to the definition and standard of identity then in effect for enriched bread, and enriched rolls, or enriched buns, as fixed and established by order of an appropriate federal agency or officer, pursuant to the Federal Food, Drug, and Cosmetic Act; provided that if during any period no such order of any such federal agency or officer fixing and establishing a definition and standard of identity for enriched bread, and enriched rolls or enriched buns, is in effect, it shall be unlawful for any person during any such period to manufacture, bake, sell, or offer for sale in this State, for human consumption, any white bread or rolls unless the same conforms to the proposed definition and standard of identity for enriched bread and enriched rolls or enriched buns promulgated by the Federal Food and Drug Administration (21 C.F.R. Part 136), or as the same as may be from time to time amended or modified. [L 1945, c 101, §3; RL 1955, §51-57; HRS §328-73; am L 1977, c 53, §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-74 Flour, wrapped bread, rolls, standard for.

§328-74 Flour, wrapped bread, rolls, standard for.
It shall be unlawful to sell or offer for sale, in this State, for human consumption therein, any flour or wrapped white bread or rolls meeting the requirements of sections 328-72 and 328-73 which fail to conform to the labeling requirements of the Federal Food, Drug, and Cosmetic Act, and the regulations promulgated thereunder, with respect to such product when introduced in interstate commerce; provided this section shall not apply to white bread or rolls which bear no labeling of any kind and which are sold directly to the consumer by the manufacturer thereof. [L 1945, c 101, §4; RL 1955, §51-58; HRS §328-74]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-76 Penalty.

§328-76 Penalty.
Any person who violates any of the provisions of sections 328-71 to 328-75 or the orders, rules or regulations of the department of health under authority thereof, shall be fined not more than $500, or imprisoned not more than one hundred days, or both. [L 1945, c 101, §6; RL 1955, §51-60; am L Sp 1959 2d, c 1, §19; HRS §328-76]
Cross References
Classification of offense and authorized punishment, see § §701-107, 706-640, and 706-663.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-79 Home-based agricultural producer of honey; exemption.

§328-79 Home-based agricultural producer of honey; exemption.
(a) A home-based agricultural producer of honey shall not be required to process honey in a certified honey house or food processing establishment, or be required to obtain a permit from the department, if the producer:
(1) Sells less than five hundred gallons of honey a year;
(2) Sells the honey directly to consumers or directly to a retail store that in turn sells the honey directly to consumers;
(3) Labels each container of honey sold with:
(A) The name and address of the producer;
(B) The net weight and volume of the honey, by standard measure;
(C) The date the honey was produced;
(D) The statement, "Honey should not be consumed by infants under one year of age." in clear and conspicuous print; and
(E) The statement, "This product is home-produced and processed and has not been inspected by the Department of Health." in clear and conspicuous print;
(4) Attends a department of health approved food safety workshop and passes the food safety certification exam; and
(5) Keeps honey production volume and honey product distribution records for a period of at least two years and makes the records available to the department.
(b) The State and counties shall not be liable for claims associated with honey distributed by home-based agricultural producers of honey; except for instances of gross negligence and intentional misconduct by the State or counties. [L 2005, c 63, pt of §1; am L 2013, c 131, §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-80 Home-based agricultural producer of honey; inspections.

§328-80 Home-based agricultural producer of honey; inspections.
If the department receives a consumer complaint about a home-based agricultural producer of honey, the producer shall be subject to food sampling and subsequent inspection of its premises to determine if the producer's products are misbranded or adulterated. [L 2005, c 63, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-94 Prescription record.

§328-94 Prescription record.
Each pharmacist or practitioner shall maintain a record of any substitution of an equivalent generic drug product or an interchangeable biological product for a prescribed brand name drug product as provided in this part. [L 1980, c 187, pt of §1; am L 1996, c 209, §5; am L 2003, c 56, §7; am L 2016, c 242, §5]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-97 Posting requirements.

§328-97 Posting requirements.
Every pharmacy shall prominently display, in clear and unobstructed public view, a sign in block letters that shall read:
"HAWAII LAW REQUIRES THAT LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG PRODUCTS AND INTERCHANGEABLE BIOLOGICAL PRODUCTS BE OFFERED TO THE CONSUMER. CONSULT YOUR PHYSICIAN AND PHARMACIST CONCERNING THE AVAILABILITY OF THE LEAST EXPENSIVE DRUG PRODUCT FOR YOUR USE."
The letters must be at least one inch in height. [L 1980, c 187, pt of §1; am L 2016, c 242, §7]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-98 Pharmacist liability.

§328-98 Pharmacist liability.
A pharmacist who selects an equivalent generic drug product or an interchangeable biological product pursuant to this part assumes no greater liability for selecting the dispensed drug product than would be incurred in filling a prescription for a drug product prescribed by its established name. [L 1980, c 187, pt of §1; am L 1996, c 209, §7; am L 2016, c 242, §8]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-99 Exceptions.

§328-99 Exceptions.
Out-of-state prescriptions filled pursuant to section 328-17.6 shall be exempt from this part. [L 1980, c 187, pt of §1; am L 1987, c 283, §22; am L 1992, c 177, §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-103 Administrative penalties.

§328-103 Administrative penalties.
(a) Any person who violates this part or any rule adopted by the department of health pursuant to this part shall be fined not more than $10,000 for each separate offense. Any action taken to collect the penalty provided for in this subsection shall be considered a civil action.
(b) In addition to any other administrative or judicial remedy provided by this part, or by rules adopted pursuant to this part, the director of health may impose by order the administrative penalty specified in this section. Factors to be considered in imposing the administrative penalty include the nature and history of the violation and of any prior violations, and the opportunity, difficulty, and history of corrective action. For any judicial proceeding to recover the administrative penalty imposed, the director of health need only show that notice was given, a hearing was held or the time granted for requesting a hearing has expired without such a request, the administrative penalty was imposed, and the penalty remains unpaid. [L 1996, c 209, pt of §1]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-104 Injunctive relief.

[ §328-104] Injunctive relief.
The director of health may institute a civil action in any court of competent jurisdiction for injunctive relief to prevent any violation of this part or of any rule adopted under this part. The court shall have the power to grant relief in accordance with the Hawaii rules of civil procedure. L 1996, c 209, pt of §1
Rules of Court
Injunctions, see HRCP rule 65.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-111 Objective.

§328-111 Objective.
The purpose of this part is to establish the minimum requirements for the storage and handling of wholesale prescription drugs and for the establishment and maintenance of prescription drug distribution records by wholesale distributors, as required by the federal Prescription Drug Marketing Act of 1987, Pub. L. 100-293, and 21 C.F.R. Part 205. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-113 Rules.

§328-113 Rules.
(a) The department may adopt such rules as may be necessary to carry out the purposes and enforce the provisions of this part and to implement the requirements of 21 Code of Federal Regulations Part 205, including minimum requirements for the storage and handling of wholesale prescription drugs; the keeping of records regarding their receipt and distribution; written policies and procedures for wholesale prescription drug distributors; and the salvaging and reprocessing of prescription drugs. All rules adopted under this part shall meet or exceed the requirements of the wholesale prescription drug distributor guidelines contained in 21 Code of Federal Regulations Part 205, and in case of conflict between any rule adopted under this part and the provisions of 21 Code of Federal Regulations Part 205, the more stringent provision shall prevail.
(b) The director may, without regard to chapter 91, adopt standards regarding conditions and temperatures for the storage of prescription drugs by reference to the provisions of an official compendium such as the United States Pharmacopeia/National Formulary (USP/NF), as updated from time to time. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-114 Notice.

§328-114 Notice.
Before any violation of this part is reported for the institution of a criminal proceeding, the person against whom the proceeding is contemplated shall be given appropriate notice and an opportunity to present the person's views before the department either orally or in writing, in person or by an attorney, with regard to the contemplated proceeding. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-115 Inspection.

§328-115 Inspection.
Wholesale distributors shall permit agents of the department, agents of the department of commerce and consumer affairs, and authorized federal, state, or local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records, written operating procedures, and lists of responsible persons, at reasonable times and in a reasonable manner, to the extent
authorized by law. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-116 Penalty; exceptions.

§328-116 Penalty; exceptions.
(a) Any person who violates this part or rules adopted under this part shall be fined not more than $500, or imprisoned not more than one year, or both.
(b) No person shall be subject to the penalties of subsection (a) of this section for having violated this part or rules adopted under this part if the person establishes a guaranty or undertaking signed by, and containing the name and address of, the individual from whom the person received the article in good faith, to the effect that the article is not adulterated or misbranded within the meaning of part I of this chapter. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-117 Administrative penalties.

§328-117 Administrative penalties.
(a) Any person who violates this part or any rule adopted by the department pursuant to this part shall be fined not more than $10,000 for each separate offense. Any action taken to collect the penalty provided for in this subsection shall be considered a civil action.
(b) In addition to any other administrative or judicial remedy provided by this part, or by rules adopted pursuant to this part, the director may impose by order the administrative penalty specified in this section. Factors to be considered in imposing the administrative penalty include the nature and history of the violation and of any prior violation, and the opportunity, difficulty, and history of corrective action. For any judicial proceeding to recover the administrative penalty imposed, the director need only show that notice was given, a hearing was held, or the time granted for requesting a hearing has expired without such a request, the administrative penalty was imposed, and the penalty remains unpaid. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-118 Injunctive relief.

§328-118 Injunctive relief.
The director may institute a civil action in any court of competent jurisdiction for injunctive relief to prevent any violation of this part or any rule adopted under this part. The court shall have powers to grant relief in accordance with the Hawaii rules of civil procedure. [L 1992, c 196, pt of §2]
Rules of Court
Injunctions, see HRCP rule 65.
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-120 Recordkeeping.

§328-120
Recordkeeping
. (a) Wholesale distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information:
(1) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;
(2) The identity and quantity of the drugs received and distributed or disposed of; and
(3) The dates of receipt and distribution or other disposition of the drugs.
(b) Inventories and records shall be made available for inspection and photocopying by the department or any authorized federal, state, or local law enforcement officials for a period of five years following disposition of the drugs.
(c) Records described in this section that are kept at the inspection site or that can be retrieved immediately by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by the department or any authorized official of a federal, state, or local law enforcement agency. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-121 Written policies and procedures.

§328-121
Written policies and procedures.
Wholesale distributors shall establish, maintain, and follow written policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies in inventories. Wholesale distributors shall include in their written policies and procedures the following:
(1) A procedure whereby the oldest approved stock of a prescription drug is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate.
(2) A procedure for handling recalls and withdrawals of prescription drugs. The procedure shall be adequate to deal with recalls and withdrawals caused by:
(A) Any action initiated at the request of the department, the Food and Drug Administration, or any other federal, state, or local law enforcement or other government agency;
(B) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or
(C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.
(3) A procedure to ensure that the distributor prepares for, protects against, and handles properly any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or in other emergencies.
(4) A procedure to ensure that all outdated prescription drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall require written documentation of the disposition of outdated prescription drugs, which documentation shall be maintained for five years after disposition of the outdated drugs. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-122 Responsible persons.

§328-122
Responsible persons.
Wholesale distributors shall establish and maintain current lists of officers, directors, managers, and other persons in charge of the wholesale distribution, storage, and handling of prescription drugs, including a description of each person's duties and a summary of each person's qualifications. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328. Food, Drugs, and Cosmetics › 328-123 Salvaging and reprocessing.

§328-123 Salvaging and reprocessing.
Wholesale distributors shall be subject to the provisions of 21 Code of Federal Regulations Parts 207, 210, and 211, regarding salvaging and reprocessing of prescription drugs. [L 1992, c 196, pt of §2]
2023 Hawaii Revised Statutes › Title 19. Health › 328C. Donation of Pharmaceuticals and Health Care Supplies › 328C-1 Definitions.

§328C-1
Definitions.
Whenever used in this chapter unless the context otherwise requires:
"Charitable, religious, or nonprofit organization" means any organization which was organized and is operating in the State for charitable or religious purposes or to promote social welfare, which is exempt from income taxation under chapter 235, and which distributes pharmaceuticals and health care supplies at no cost to needy persons.
"Institutional facility" means a:
(1) Hospital;
(2) Convalescent home;
(3) Nursing home;
(4) Extended care facility;
(5) Mental institution;
(6) Rehabilitation center;
(7) Health maintenance organization;
(8) Psychiatric center;
(9) Intellectual disability center;
(10) Penal institution; or
(11) Any other organization whose primary purpose is to provide a physical environment for patients to obtain health care services or at-home care services, except those places where physicians, dentists, veterinarians, osteopaths, podiatrists, or other prescribers who are duly licensed, engage in private practice.
"Needy person" means any natural person who lacks the means to obtain adequate or proper pharmaceuticals or health care supplies, as determined by a practitioner at a Hawaii qualified health center, established under section 346-41.5, to be in need of service.
"Pharmaceuticals and health care supplies" means any medicine (prescription or nonprescription, excluding all controlled substances listed in chapter 329) or health care supplies such as soap, personal sanitary products, baby formula, dietary supplement, health care aids such as thermometers, surgical gloves, or bandages, or any other item which is customarily fit for human consumption or external use, before the expiration date stamped on the product, if any. [L 1997, c 337, pt of §2; am L 2001, c 207, §1; am L 2004, c 190, § §4, 11; am L 2011, c 220, §12]
2023 Hawaii Revised Statutes › Title 19. Health › 328C. Donation of Pharmaceuticals and Health Care Supplies › 328C-3 Sale of donated pharmaceuticals or health care supplies, prohibited; fines.

§328C-3
Sale of donated pharmaceuticals or health care supplies, prohibited; fines.
(a) No person or organization shall sell, or offer for sale, any pharmaceutical or health care supply donated or distributed under this chapter.
(b) Any violation of this section is punishable by a fine not to exceed $1,000. [L 1997, c 337, pt of §2]