410 ILCS 620/14 — Illinois Code / Chapter 410 / Act 620 / Section 14
Section 14
Status: in_force

(410 ILCS 620/14) (from Ch. 56 1/2, par. 514) (Text of Section before amendment by P.A. 104-432) Sec. 14. A drug or device is adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid or decomposed substance; or (2) (A) if it has been produced, 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; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of the Act as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess; 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 (A) it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of Section 706 of the Federal Act or (B) it is a color additive, the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of Section 706 of the Federal Act; or (5) if it is a new animal drug which is unsafe within the meaning of Section 512 of the Federal Act; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of Section 512 of the Federal Act. (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 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 authority of the Federal Act. No drug defined in an official compendium is 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. When a drug is recognized in both the United States Pharmacopoeia - National Formulary and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia - National Formulary 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 - National Formulary. (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. (e) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under Section 514 of the Federal Act, unless such device is in all respects in conformity with such standard. (f) If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installations are not in conformity with applicable requirements under Section 520(b)(1) of the Federal Act or an applicable condition as prescribed by an order under Section 520(b)(2) of the Federal Act. (g) If it is a device for which an exemption has been granted under Section 520(g) of the Federal Act for investigational use and the person who was granted such exemption fails to comply with a requirement prescribed by or under such Section. (Source: P.A. 84-891.) (Text of Section after amendment by P.A. 104-432) Sec. 14. A drug or device is adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid or decomposed substance; or (2) (A) if it has been produced, 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; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of the Act as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess; 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 (A) it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of Section 706 of the Federal Act or (B) it is a color additive, the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of Section 706 of the Federal Act; or (5) if it is a new animal drug which is unsafe within the meaning of Section 512 of the Federal Act; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of Section 512 of the Federal Act. (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 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 authority of the Federal Act. No drug defined in an official compendium is 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. When a drug is recognized in both the United States Pharmacopoeia - National Formulary and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia - National Formulary 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 - National Formulary. (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. (e) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under Section 514 of the Federal Act, unless such device is in all respects in conformity with such standard. (f) If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installations are not in conformity with applicable requirements under Section 520(b)(1) of the Federal Act or an applicable condition as prescribed by an order under Section 520(b)(2) of the Federal Act. (g) If it is a device for which an exemption has been granted under Section 520(g) of the Federal Act for investigational use and the person who was granted such exemption fails to comply with a requirement prescribed by or under such Section. (h) If a drug had been approved by the U.S. Food and Drug Administration before January 1, 2025, the revocation of approval of the drug by the U.S. Food and Drug Administration after that date shall not cause it to be deemed an adulterated drug in violation of this Act if the drug is recommended for use by the World Health Organization, even if the drug's labeling reflects prior approval that is no longer in effect, so long as the drug's labeling was true and accurate at the time of its manufacture. This subsection (h) is inoperative on and after January 1, 2035. (Source: P.A. 104-432, eff. 1-1-26.)