21 U.S. Code § 351 - Adulterated drugs and devices
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, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph 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. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic 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 homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.
If it is not subject to the provisions of paragraph (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.
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.
If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 360j(f)(1) of this title or an applicable condition prescribed by an order under section 360j(f)(2) of this title.
If it is a device for which an exemption has been granted under section 360j(g) of this title for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.
If it is a drug or device and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
For purposes of paragraph (a)(2)(B), the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.
 So in original. Probably should be “subparagraph”.
2017—Par. (j). Pub. L. 115–52 inserted “or device” after “drug”.
2012—Pub. L. 112–144, § 711, inserted concluding provisions.
Par. (f)(1)(A)(i). Pub. L. 112–144, § 608(b)(2)(A)(i), substituted “an order issued” for “a regulation promulgated”.
Par. (f)(1)(A)(ii)(I). Pub. L. 112–144, § 608(b)(2)(A)(ii), substituted “issuance of such order” for “promulgation of such regulation”.
Par. (f)(2)(B). Pub. L. 112–144, § 608(b)(2)(B), substituted “an order issued” for “a regulation promulgated” in introductory provisions and “issuance of such order” for “promulgation of such regulation” in subcl. (ii).
Par. (f)(3). Pub. L. 112–144, § 608(b)(2)(C), added subpar. (3).
Par. (j). Pub. L. 112–144, § 707(a), added par. (j).
1997—Par. (a)(2)(C). Pub. L. 105–115, § 121(b)(1), inserted “; 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;” before “or (3)”.
Par. (e). Pub. L. 105–115, § 204(c), designated existing provisions as subpar. (1) and added subpar. (2).
1992—Par. (a)(4). Pub. L. 102–571 substituted “379e(a)” for “376(a)” in cls. (A) and (B).
1990—Par. (f)(1). Pub. L. 101–629, § 9(b), which directed the amendment of subpars. (A) to (C) of par. (f), was executed by making the amendments in cls. (A) to (C) of subpar. (1) of par. (f) as follows to reflect the probable intent of Congress: in cl. (A)(ii)(II), substituted “, suspended, or withdrawn” for “or withdrawn”; in cl. (B)(ii), substituted “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”; and in cl. (C), substituted “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”.
1976—Par. (a). Pub. L. 94–295, § 9(b)(1), substituted “(3) if its” for “(3) if it is a drug and its” in cl. (3), substituted “(4) if (A) it bears or contains” for “(4) if (A) it is a drug which bears or contains” in cl. (4)(A), and substituted “drugs or devices” for “drugs” in cl. (4)(B).
Pars. (e) to (i). Pub. L. 94–295, § 3(d), added pars. (e) to (i).
1968—Par. (a). Pub. L. 90–399 added cls. (5) and (6).
1962—Par. (a). Pub. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B).
1960—Par. (a). Pub. L. 86–618 substituted provisions in cl. (4) relating to unsafe color additives for provisions which related to a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 354 of this title.
Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.
Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
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