§328-4  Same; antiseptic, germicide; newdrug; contamination.  (a)  The representation of a drug, in its labeling,or advertisement, as an antiseptic shall be considered to be a representationthat it is a germicide, except in the case of a drug purporting to be, orrepresented 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 drugthe composition of which is such that the drug is not generally recognized,among experts qualified by scientific training and experience to evaluate thesafety and effectiveness of drugs, as safe and effective for use under theconditions prescribed, recommended, or suggested in the labeling thereof; or (2)any drug the composition of which is such that the drug, as a result ofinvestigations to determine its safety and effectiveness for use under suchconditions, has become so recognized, but which has not, otherwise than in suchinvestigations, been used to a material extent or for a material time undersuch conditions.

(c)  "Contaminated with filth"applies to any food, drug, device, or cosmetic not securely protected fromdust, dirt, and as far as may be necessary by all reasonable means, from allforeign 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]