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