Title 19, Health

PART I. HAWAII FOOD, DRUG, AND COSMETIC ACT §328-1 Definitions. For the purposes of this chapter: "Agent" means a person who acts on behalf of or under the direction of another person. "Brand" or "brand name" means any registered trade name commonly used to identify a drug. "Cert…

§328-10 Foods deemed misbranded when. A food shall be deemed to be misbranded:

[§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…

[§328-102] Criminal penalty. Any person who wilfully violates this part or rules adopted under this part shall be guilty of a misdemeanor. [L 1996, c 209, pt of §1]

[§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…

[§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 accordanc…

[§328-105] Powers and duties. The department of health shall enforce this part and shall have, in connection therewith, all the powers and duties conferred and imposed upon it pursuant to part I. [L 1996, c 209, pt of §1]

§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…

[PART VII.] WHOLESALE PRESCRIPTION DRUGS: STORAGE, HANDLING, AND RECORDKEEPING [§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 prescri…

[§328-112] Definitions. As used in this part: "Blood" means whole blood collected from a single donor and processed either for transfusion or for further manufacturing. "Blood component" means that part of blood separated by physical or mechanical means. "Common control" means th…

[§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 handlin…

[§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 or…

[§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 audi…

[§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 vi…

[§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 …

[§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 Hawai…

[§328-119] Minimum requirements for the storage and handling of prescription drugs. Wholesale distributors of prescription drugs and their officers, agents, representatives, and employees shall ensure that the following requirements are met:

§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: (b) Unpackaged processed food may be displayed and so…

[§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: (b) Inventories …

[§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:

§328-15 Drugs or devices deemed misbranded when; prescriptions excepted, when. A drug or device shall be deemed to be misbranded:

§328-16 Drugs limited to dispensing on prescription. (a) A prescription drug shall be dispensed only if its label bears the following: If any prescription for a drug does not indicate the number of times it may be refilled, if any, the pharmacist shall not refill that prescriptio…

[§328-16.2] Customized patient medication package. (a) A pharmacy may provide a customized patient medication package to any person; provided that: (b) As used in this section, "customized patient medication package" means a package that is prepared by a pharmacist for a specific…

[§328-16.5] Prescription labeling. (a) A practitioner or the practitioner's authorized representative shall: (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 consum…

§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: Every prescription dispensed shall have the name of t…

[§328-17.8] Electronic prescription information. (a) Prescription information may be transmitted electronically; provided that: (b) Nothing in this section shall be construed or interpreted to prevent the transmission of health care information, including prescription information…

[§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:

§328-19 Cosmetics deemed misbranded when. A cosmetic shall be deemed to be misbranded:

§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: (b) If any food, drug, device, cosmetic, or consumer commodity is found to b…

§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…