65-668.Same; drugs or devices deemed adulterated, when.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) (A) if it has been produced, prepared,packed or held under insanitary conditions whereby it may have beencontaminated with filth, or whereby it may have been rendered injuriousto health; or (B) if it is a drug and the methods used in, or thefacilities or controls used for, its manufacture, processing, packing,or holding do not conform to or are not operated or administered inconformity with current good manufacturing practice to assure that suchdrug meets the requirements of this act as to safety and has theidentity and strength, and meets the quality and purity characteristics,which it purports or is represented to possess; or (3) if it is a drugand its container is composed, in whole or in part, of any poisonous ordeleterious substance which may render the contents injurious to health;or (4) if (A) it is a drug and it bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning ofK.S.A. 65-667, or (B) it is a color additive, the intended use of whichin or on drugs is for purposes of coloring only, and is unsafe withinthe meaning of K.S.A. 65-667.
(b) If it purports to be or is represented as a drug the name ofwhich is recognized in an official compendium, and its strength differsfrom, or its quality or purity falls below, the standard set forth insuch compendium. Such determination as to strength, quality, or purityshall be made in accordance with the tests or methods of assay set forthin such compendium, or in the absence of or inadequacy of such tests ormethods of assay, those prescribed under authority of the federal act.No drug defined in any official compendium shall be deemed to beadulterated under this paragraph because it differs from the standard ofstrength, quality, or purity therefor set forth in such compendium, ifits difference in strength, quality, or purity from such standard isplainly stated on its label. Whenever a drug is recognized in both theUnited States pharmacopoeia and the homeopathic pharmacopoeia of theUnited States it shall be subject to the requirements of the UnitedStates pharmacopoeia unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions ofthe homeopathic phamacopoeia of the United States and not to those ofthe United States pharmacopoeia.
(c) If it is not subject to the provisions of paragraph (b) of thissection and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.
(d) If it is a drug and any substance has been (1) mixed or packedtherewith so as to reduce its quality or strength; or (2) substitutedwholly or in part therefor.
History: L. 1953, ch. 286, § 14; L. 1965, ch. 377, § 5; July 1.
65-668.Same; drugs or devices deemed adulterated, when.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) (A) if it has been produced, prepared,packed or held under insanitary conditions whereby it may have beencontaminated with filth, or whereby it may have been rendered injuriousto health; or (B) if it is a drug and the methods used in, or thefacilities or controls used for, its manufacture, processing, packing,or holding do not conform to or are not operated or administered inconformity with current good manufacturing practice to assure that suchdrug meets the requirements of this act as to safety and has theidentity and strength, and meets the quality and purity characteristics,which it purports or is represented to possess; or (3) if it is a drugand its container is composed, in whole or in part, of any poisonous ordeleterious substance which may render the contents injurious to health;or (4) if (A) it is a drug and it bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning ofK.S.A. 65-667, or (B) it is a color additive, the intended use of whichin or on drugs is for purposes of coloring only, and is unsafe withinthe meaning of K.S.A. 65-667.
(b) If it purports to be or is represented as a drug the name ofwhich is recognized in an official compendium, and its strength differsfrom, or its quality or purity falls below, the standard set forth insuch compendium. Such determination as to strength, quality, or purityshall be made in accordance with the tests or methods of assay set forthin such compendium, or in the absence of or inadequacy of such tests ormethods of assay, those prescribed under authority of the federal act.No drug defined in any official compendium shall be deemed to beadulterated under this paragraph because it differs from the standard ofstrength, quality, or purity therefor set forth in such compendium, ifits difference in strength, quality, or purity from such standard isplainly stated on its label. Whenever a drug is recognized in both theUnited States pharmacopoeia and the homeopathic pharmacopoeia of theUnited States it shall be subject to the requirements of the UnitedStates pharmacopoeia unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions ofthe homeopathic phamacopoeia of the United States and not to those ofthe United States pharmacopoeia.
(c) If it is not subject to the provisions of paragraph (b) of thissection and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.
(d) If it is a drug and any substance has been (1) mixed or packedtherewith so as to reduce its quality or strength; or (2) substitutedwholly or in part therefor.
History: L. 1953, ch. 286, § 14; L. 1965, ch. 377, § 5; July 1.
65-668.Same; drugs or devices deemed adulterated, when.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) (A) if it has been produced, prepared,packed or held under insanitary conditions whereby it may have beencontaminated with filth, or whereby it may have been rendered injuriousto health; or (B) if it is a drug and the methods used in, or thefacilities or controls used for, its manufacture, processing, packing,or holding do not conform to or are not operated or administered inconformity with current good manufacturing practice to assure that suchdrug meets the requirements of this act as to safety and has theidentity and strength, and meets the quality and purity characteristics,which it purports or is represented to possess; or (3) if it is a drugand its container is composed, in whole or in part, of any poisonous ordeleterious substance which may render the contents injurious to health;or (4) if (A) it is a drug and it bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning ofK.S.A. 65-667, or (B) it is a color additive, the intended use of whichin or on drugs is for purposes of coloring only, and is unsafe withinthe meaning of K.S.A. 65-667.
(b) If it purports to be or is represented as a drug the name ofwhich is recognized in an official compendium, and its strength differsfrom, or its quality or purity falls below, the standard set forth insuch compendium. Such determination as to strength, quality, or purityshall be made in accordance with the tests or methods of assay set forthin such compendium, or in the absence of or inadequacy of such tests ormethods of assay, those prescribed under authority of the federal act.No drug defined in any official compendium shall be deemed to beadulterated under this paragraph because it differs from the standard ofstrength, quality, or purity therefor set forth in such compendium, ifits difference in strength, quality, or purity from such standard isplainly stated on its label. Whenever a drug is recognized in both theUnited States pharmacopoeia and the homeopathic pharmacopoeia of theUnited States it shall be subject to the requirements of the UnitedStates pharmacopoeia unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions ofthe homeopathic phamacopoeia of the United States and not to those ofthe United States pharmacopoeia.
(c) If it is not subject to the provisions of paragraph (b) of thissection and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.
(d) If it is a drug and any substance has been (1) mixed or packedtherewith so as to reduce its quality or strength; or (2) substitutedwholly or in part therefor.
History: L. 1953, ch. 286, § 14; L. 1965, ch. 377, § 5; July 1.
