View all text of Part A [§ 351 - § 360n-2]
§ 351. Adulterated drugs and devicesA drug or device shall be deemed to be adulterated—
(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture
(1) 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
(b) Strength, quality, or purity differing from official compendium
(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium
(d) Mixture with or substitution of another substance
(e) Devices not in conformity with performance standards
(1) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 360d of this title unless such device is in all respects in conformity with such standard.
(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 360d(c) of this title unless such device is in all respects in conformity with such standard.
(f) Certain class III devices
(1) If it is a class III device—
(A)
(i) which is required by an order issued under subsection (b) of section 360e of this title to have an approval under such section of an application for premarket approval and which is not exempt from section 360e of this title under section 360j(g) of this title, and
(ii)(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the issuance of such order, or(II) for which such an application was filed and approval of the application has been denied, suspended, or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn;
(B)
(i) which was classified under section 360c(f) of this title into class III, which under section 360e(a) of this title is required to have in effect an approved application for premarket approval, and which is not exempt from section 360e of this title under section 360j(g) of this title, and
(ii) which has an application which has been suspended or is otherwise not in effect; or
(C) which was classified under section 360j(l) of this title into class III, which under such section is required to have in effect an approved application under section 360e of this title, and which has an application which has been suspended or is otherwise not in effect.
(2)
(A) In the case of a device classified under section 360c(f) of this title into class III and intended solely for investigational use, paragraph 1
1 So in original. Probably should be “subparagraph”.
(1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 360j(g)(2) of this title.(B) In the case of a device subject to an order issued under subsection (b) of section 360e of this title, paragraph 1 (1) shall not apply with respect to such device during the period ending—
(i) on the last day of the thirtieth calendar month beginning after the month in which the classification of the device in class III became effective under section 360c of this title, or
(ii) on the ninetieth day after the date of the issuance of such order,
whichever occurs later.
(3) In the case of a device with respect to which a regulation was promulgated under section 360e(b) of this title prior to July 9, 2012, a reference in this subsection to an order issued under section 360e(b) of this title shall be deemed to include such regulation.
(g) Banned devices
(h) Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions
(i) Failure to comply with requirements under which device was exempted for investigational use
(j) Delayed, denied, or limited inspection; refusal to permit entry or inspection
(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.)