Adulterated drugs and devices

If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been 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 (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 this chapter 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 (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if 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 bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title , 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 379e(a) of this title ; or (5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title ; 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 360b of this title .

( June 25, 1938, ch. 675, § 501 , 52 Stat. 1049 ; Pub. L. 86–618, title I, § 102(b)(1) , July 12, 1960 , 74 Stat. 398 ; Pub. L. 87–781, title I, § 101 , Oct. 10, 1962 , 76 Stat. 780 ; Pub. L. 90–399, § 101(a) , July 13, 1968 , 82 Stat. 343 ; Pub. L. 94–295 , §§ 3(d), 9(b)(1), May 28, 1976 , 90 Stat. 576 , 583; Pub. L. 101–629, § 9(b) , Nov. 28, 1990 , 104 Stat. 4521 ; Pub. L. 102–571, title I, § 107(8) , Oct. 29, 1992 , 106 Stat. 4499 ; Pub. L. 105–115, title I, § 121(b)(1) , title II, § 204(c), Nov. 21, 1997 , 111 Stat. 2320 , 2336; Pub. L. 112–144, title VI, § 608(b)(2) , title VII, §§ 707(a), 711, July 9, 2012 , 126 Stat. 1058 , 1068, 1071; Pub. L. 115–52, title VII, § 702(c) , Aug. 18, 2017 , 131 Stat. 1056 .)