Title 19, Health

§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 …

[§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]

[§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]

[§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 l…

[§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 o…

[§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, recor…

[§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 dut…

[§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]

§328-13 Adding of poisonous or deleterious substance, regulation of. (a) Any added poisonous or deleterious substance, and food additive, any pesticide chemical in or on a raw agricultural commodity, or any color additive, shall, with respect to any particular use or intended use…

§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 conditio…

§328-15 Drugs or devices deemed misbranded when; prescriptions excepted, when. A drug or device shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular, or if its labeling or packaging fails to conform with the requirements of section 328-19…

§328-16 Drugs limited to dispensing on prescription. (a) A prescription drug shall be dispensed only if its label bears the following: (1) The name, business address, and telephone number of the seller. The business address shall be the physical location of the pharmacy or the di…

[§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; prov…

[§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) Info…

§328-17 New drugs, regulation of sale, etc.; exceptions. (a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless (1) an application with respect thereto has been approved and the approval has not been withdrawn under section 505 of the F…

§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 p…

§328-17.6 Out-of-state prescriptions. (a) An out-of-state practitioner may issue a written, oral, or electronic prescription within the confines of the practitioner's license and in accordance with Hawaii laws and rules. An oral or electronic prescription shall be issued by the o…

§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: (…

[§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 oxyge…

[§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…

§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 u…

§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, un…

§328-19.1 Consumer commodities; labeling; packaging. (a) All labels of consumer commodities, as defined by this part, shall conform with the requirements for the declaration of net quantity of contents of section 4 of the Fair Packaging and Labeling Act (15 U.S.C. 1451, et seq.) …

§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 consider…

§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 i…

§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…

§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 sam…

§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 f…

§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 agen…

§328-25 Director's right to inspect, require recordkeeping, demand records, seize, and conduct hearings. (a) The director of health or any of the director's agents may in the performance of their duties: (1) Enter at all reasonable hours into any creamery, factory, restaurant, st…

§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 …

§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 …

§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 prosecute…

§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) …

§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,…

§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 con…

[§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…

§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, …

PART II. COLD STORAGE OF FOOD §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 re…

§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 heal…

§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…

§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 …

§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…

§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 good…

§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 dis…

§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]