Section 780-107 - AdulterationA controlled substance, other drug, device or cosmetic shall be deemed to be adulterated:
(1)(i) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; (ii) if it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; (iii) and if it is a drug or a device its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; (iv) if it has been exposed to conditions of fire, water or extreme temperature, which may have rendered it injurious to health; (v) if (A) it bears or contains for purposes of coloring only a color additive, unless it be a hair dye which is unsafe within the meaning of section 9 of this act, or (B) it is a color additive the intended use of which in or on drugs, devices or cosmetics is for purposes of coloring only and is unsafe, unless it be a hair dye within the meaning of section 9 of this act.(2) If it purports to be or is represented as a drug or device, the name of which is recognized in an official compendium and its strength differs from or its quality or purity falls below the standards set forth in such compendium. Such determination as to strength, quality or purity, shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay those prescribed under the authority of the Federal act. No drug or device defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality or purity therefor set forth in such compendium, if its difference in strength, quality or purity from such standard is plainly stated on its label.(3) If it is a color additive and is to be used or is recommended for use as a hair dye and it is not exempt under section 9 unless its label bears the following legend conspicuously displayed thereon: "Caution. This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows, to do so may cause blindness," and the labeling bears adequate directions for such preliminary testing. For the purpose of this paragraph, the term "hair dye" shall not include eyelash dyes or eyebrow dyes.(4) If it is not subject to the provisions of clause (2) of this section and its strength differs from or its purity or quality falls below that which it purports or is represented to possess.(5) If it is a drug or device and any substance has been (i) mixed or packed therewith so as to reduce its quality or strength, or (ii) substituted wholly or in part therefor.1972, April 14, P.L. 233, No. 64, § 7, eff. 6/14/1972.