§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, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.
(b) "New drug" means (1) any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
(c) "Contaminated with filth" applies to any food, drug, device, or cosmetic not securely protected from dust, dirt, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations. [L 1941, c 318, pt of §2; RL 1945, §2204; RL 1955, §51-4; am L 1967, c 152, §2; HRS §328-4]
Structure Hawaii Revised Statutes
328. Food, Drugs, and Cosmetics
328-3 Same; misbranding or misleading advertisement.
328-4 Same; antiseptic, germicide; new drug; contamination.
328-5 Same; "selling" includes what.
328-7 Remedies for violation of law.
328-8 Regulations to be prescribed.
328-9 Foods deemed adulterated when.
328-10 Foods deemed misbranded when.
328-10.5 Regulations for exemption from labeling requirements.
328-12 Suspension and reinstatement of permits.
328-12.4 Food establishments; use of latex gloves prohibited.
328-12.7 Display of unpackaged processed food.
328-13 Adding of poisonous or deleterious substance, regulation of.
328-14 Drugs or devices deemed adulterated when.
328-15 Drugs or devices deemed misbranded when; prescriptions excepted, when.
328-16 Drugs limited to dispensing on prescription.
328-16.2 Customized patient medication package.
328-16.5 Prescription labeling.
328-17 New drugs, regulation of sale, etc.; exceptions.
328-17.5 Principal labeler responsibility under recall of drug.
328-17.6 Out-of-state prescriptions.
328-17.7 Record of prescriptions.
328-17.8 Electronic prescription information.
328-18 Cosmetics deemed adulterated when.
328-19 Cosmetics deemed misbranded when.
328-19.1 Consumer commodities; labeling; packaging.
328-20 False advertising; exceptions.
328-21 Rules and regulations, hearings.
328-23 Inspection powers of director.
328-24 Furnishing of samples to director.
328-26 Disposal of questioned articles; court orders; expenses; bond.
328-27 Perishables destroyed when.
328-28 Duties of county attorneys, prosecuting attorney.
328-30 Administrative penalties.
328-42 Department of health regulations.
328-43 Records, food to be marked.
328-45 Length of storage time.
328-47 Cold stored goods to be labeled; sales of.
328-49 What fish and when same may be put in cold storage for future sale.
328-50 Fishing on commercial fishing vessels.
328-51 Causing preventable deterioration of; penalty.
328-65 Administration and enforcement.
328-72 Flour must be enriched.
328-73 Bread, rolls, buns, standard for.
328-74 Flour, wrapped bread, rolls, standard for.
328-75 Enforcement; suspension.
328-79 Home-based agricultural producer of honey; exemption.
328-80 Home-based agricultural producer of honey; inspections.
328-92 Drug product and biological product selection.
328-96 Hawaii list of equivalent generic drug products and interchangeable biological products.
328-103 Administrative penalties.
328-106 Pharmacy benefit manager; maximum allowable cost.
328-117 Administrative penalties.
328-119 Minimum requirements for the storage and handling of prescription drugs.