§328-14  Drugs or devices deemed adulteratedwhen.  A drug or device shall be deemed to be adulterated:

(1)  (A)  If it consists in whole or in part of anyfilthy, putrid, or decomposed substance; or

(B)  (i)  If it has been produced, prepared, packed,or held under insanitary conditions whereby it may have been contaminated withfilth, or whereby it may have been rendered injurious to health; or

(ii)  If the methods used in, or the facilitiesor controls used for, its manufacture, processing, packing, or holding do notconform to or are not operated or administered in conformity with current goodmanufacturing practice to assure that the drug or device meets the requirementsof this part as to safety and has the identity and strength, and meets the qualityand purity characteristics which it purports or is represented to possess; or

(C)  If its container is composed, in whole orin part, of any poisonous or deleterious substance which may render thecontents injurious to health; or

(D)  If:

(i)  It bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning of theFederal Act; or

(ii)  It is a color additive, the intended use ofwhich is for purposes of coloring only, and is unsafe within the meaning of theFederal Act;

(2)  If it purports to be or is represented as a drugthe name of which is recognized in an official compendium, and its strengthdiffers from, or its quality or purity falls below, the standard set forth inthe compendium.  Such a determination as to strength, quality, or purity shallbe made in accordance with the tests or methods of assay set forth in thecompendium, or in the absence of or inadequacy of these tests or methods ofassay, those prescribed under authority of the Federal Act.  No drug defined inan official compendium shall be deemed to be adulterated under this paragraphbecause it differs from the standard of strength, quality, or purity thereforset forth in the compendium, if its difference in strength, quality, or purityfrom that standard is plainly stated on its label.  Whenever a drug isrecognized in both the United States Pharmacopoeia and the HomeopathicPharmacopoeia of the United States it shall be subject to the requirements ofthe United States Pharmacopoeia unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the HomeopathicPharmacopoeia of the United States and not those of the United StatesPharmacopoeia;

(3)  If it is not subject to paragraph (2) and itsstrength differs from, or its purity or quality falls below, that which itpurports or is represented to possess;

(4)  If it is a drug and any substance has been (A)mixed or packed therewith so as to reduce its quality or strength; or (B)substituted wholly or in part therefor. [L 1941, c 318, §10; RL 1945, §2214; RL1955, §51-14; am L 1967, c 152, §8; HRS §328-14; am L 1995, c 6, §1]