Hawaii Revised Statutes 328. Food, Drugs, and Cosmetics
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...
- 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...
- 328-2.1 Repealed.
L 1977, c 58, §44 and c 200, §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...
- 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...
- 328-5 Same; "Selling" Includes What.
The provisions of this part regarding the selling of food, drugs, devices, or cosmetics, include the manufacture, production, processing, packing, exposure, offer, possession, and...
- 328-6 Prohibited Acts.
The following acts and the causing thereof within the State by any person are prohibited: (1) The manufacture, sale, delivery, holding, or offering for...
- 328-7 Remedies for Violation of Law.
In addition to the remedies hereinafter provided the department of health may apply to a circuit judge for and the judge shall have jurisdiction...
- 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...
- 328-9 Foods Deemed Adulterated When.
A food shall be deemed to be adulterated: (1) (A) If it bears or contains any poisonous or deleterious substance which may render it...
- 328-10 Foods Deemed Misbranded When.
A food shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular; or if its labeling or...
- 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,...
- 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...
- 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...
- 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...
- 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...
- 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,...
- 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,...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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,...
- 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...
- 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...
- 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...
- 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,...
- 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...
- 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)...
- 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...
- 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...
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...
- 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,...
- 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...
- 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...
- 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...
- 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...
- 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,...
- 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...
- 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,...
- 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...
- 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...
PART III. FROZEN FOOD PRODUCTS
- 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...
- 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...
- 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...
- 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...
- 328-65 Administration and Enforcement.
The department of health shall administer and enforce this part. [L 1967, c 206, pt of §1; HRS §328-65]
- 328-66 Thawed Food.
The term “thawed food” means food previously frozen throughout at a temperature of, or below thirty-two degrees Fahrenheit. [L 1980, c 40, §1]
PART IV. ENRICHMENT OF BREAD AND FLOUR
- 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...
- 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...
- 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...
- 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...
- 328-75 Enforcement; Suspension.
(a) The department of health shall enforce sections 328-71 to 328-76 and shall have, in connection therewith, all the powers and duties conferred and...
- 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...
Part IVA. honey
PART V. DRUG ABUSE, CONTROL--REPEALED
- 328-81 to 89 Repealed.
L 1972, c 10, §§7, 8. Cross References For present provisions, see chapter 321, part XVI, and chapter 329.
PART VI. DRUG PRODUCT SELECTION
- 328-91 Definitions.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-92 Drug Product Selection.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-93 Repealed.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-94 Prescription Record.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-95 Establishment of Drug Product Selection Board.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-96 Drug Formulary; Hawaii Additions and Deletions List.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-97 Posting Requirements.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-98 Pharmacist Liability.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-99 Exceptions.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-100 Repealed.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-101 Repealed.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-102 Criminal Penalty.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-103 Administrative Penalties.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-104 Injunctive Relief.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-105 Powers and Duties.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
- 328-106 Pharmacy Benefit Manager; Maximum Allowable Cost.
Pharmacy benefit managers; health information; prohibited marketing practices, see §487J-7. Prescription drug benefits, see chapter 431R. Prescription drugs; mail order opt out option, see...
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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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: (1) Facilities. All facilities at...
- 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....
- 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...
- 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...
- 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...
Last modified: October 27, 2016