§ 21-31-14 - Adulterated drug or device.
SECTION 21-31-14
§ 21-31-14 Adulterated drug or device.– A drug or device shall be deemed to be adulterated:
(1) If: (i) it consists in whole or in part of any filthy,putrid, or decomposed substance; (ii) it has been produced, prepared, packed,or held under unsanitary conditions by which it may have been contaminated withfilth, or by which it may have been rendered injurious to health; (iii) it is adrug and its container is composed, in whole or in part, of any poisonous ordeleterious substance which may render the contents injurious to health; or(iv) it is a drug and it bears or contains, for purposes of coloring only, acoal-tar color other than one from a batch certified under the authority of theFederal Act.
(2) If it purports to be or is represented as a drug the nameof which is recognized in an official compendium, and its strength differsfrom, or its quality or purity falls below, the standard set forth in thecompendium. A determination as to strength, quality, or purity shall be made inaccordance with the tests or methods of assay set forth in the compendium, orin the absence of or inadequacy of the tests or methods of assay, thoseprescribed under authority of the Federal Act. No drug defined in an officialcompendium shall be deemed to be adulterated under this subdivision because itdiffers from the standard of strength, quality, or purity set forth in anofficial compendium, if its difference in strength, quality, or purity from thestandard is plainly stated on its label. Whenever a drug is recognized in boththe United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the UnitedStates it shall be subject to the requirements of the United StatesPharmacopoeia unless it is labeled and offered for sale as a homeopathic drug,in which case it shall be subject to the provisions of the HomeopathicPharmacopoeia of the United States and not to those of the United StatesPharmacopoeia.
(3) If it is not subject to the provisions of subdivision (2)of this section and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.
(4) If it is a drug and any substance has been: (i) mixed orpacked with it so as to reduce its quality or strength; or (ii) substitutedwholly or in part for it.