§ 21a-105 — (Formerly Sec. 19-225). Adulterated drugs and devices.

A drug or device shall be deemed to be adulterated: (a) (1) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (2) if it has been produced, prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for the purposes of coloring only, a color additive which is unsafe within the meaning of section 21a-104; or (5) if it is a drug which has been stored, kept or held under conditions contrary to the cautionary label statements on the package or contrary to the recommendations as stated within the official compendium; or (6) if it has not been manufactured in accordance with good manufacturing practices as defined in the federal Food and Drug Act Parts 211 and 820; (b) if it purports to be, or is represented as, a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium; such determination as to strength, quality or purity to be made in accordance with the tests or methods of assay set forth in such compendium or prescribed by regulations promulgated under Section 351(b) of the federal act, provided no drug 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 and provided, whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia; (c) if it is not subject to the provisions of subsection (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess; (d) if it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.

Legislative History

(1949 Rev., S. 3943; 1963, P.A. 359, S. 5; P.A. 74-41, S. 1, 2; P.A. 85-497, S. 1.) History: 1963 act deleted reference in Subsec. (a)(4) to coal tar color not suitable for use in drugs as provided by regulations promulgated under section 354 of the federal act, substituting color additive unsafe within meaning of Sec. 19-224; P.A. 74-41 added provision ruling that drug is adulterated if stored, kept or held under conditions contrary to label statements or recommendations of the official compendium; Sec. 19-225 transferred to Sec. 21a-105 in 1983; P.A. 85-497 added Subsec. (a)(6) which provides that a drug or device shall be deemed adulterated if it has not been manufactured in accordance with practices defined by the federal Food and Drug Act.