Source: http://www4.law.cornell.edu/uscode/text/21/351?quicktabs_8=4
Timestamp: 2013-12-11 08:24:37
Document Index: 342686728

Matched Legal Cases: ['§ 351', '§ 351', '§ 351', '§ 501', '§ 102', '§ 101', '§ 101', '§ 3', '§ 9', '§ 107', '§ 121', '§ 204', '§ 121', '§ 204', '§ 9', '§ 9', '§ 3', '§ 3512012112', '§ 351', '§ 3512012112', '§ 351', '§ 3512012112']

21 USC § 351 - Adulterated drugs and devices | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter V › Part A › § 351	prevnext
21 USC § 351 - Adulterated drugs and devices
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)
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)
it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e
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.
Strength, quality, or purity differing from official compendium 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.
Misrepresentation of strength, etc., where drug is unrecognized in compendium 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.
Mixture with or substitution of another substance 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.
Devices not in conformity with performance standards (1)
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.
Certain class III devices (1)
If it is a class III device—
which is required by an order issued under subsection (b) ofsection 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
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
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.
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)(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
In the case of a device subject to an order issued under subsection (b) ofsection 360e of this title, paragraph [1]
(1) shall not apply with respect to such device during the period ending—
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.
Banned devices If it is a banned device.
Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions 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
Failure to comply with requirements under which device was exempted for investigational use 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.
Delayed, denied, or limited inspection; refusal to permit entry or inspection If it is a drug 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.
which is required by a regulation promulgated under subsection (b) ofsection 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
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 promulgation of such regulation, or
In the case of a device subject to a regulation promulgated under subsection (b) ofsection 360e of this title, paragraph [1]
on the ninetieth day after the date of the promulgation of such regulation,
(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.)
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. 102–571substituted “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. 90–399added cls. (5) and (6).
1962—Par. (a). Pub. L. 87–781designated existing provisions of cl. (2) as (A) and added (B).
1960—Par. (a). Pub. L. 86–618substituted 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.
Section 121(b)(2) ofPub. L. 105–115provided that: “Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) ofPub. L. 105–115, set out as a note under section 355 of this title], whichever is later.”
Amendment by Pub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 3512012112-144 [Sec.] 711126 Stat. 1071 § 351nt new2012112-144 [Sec.] 707(b)126 Stat. 1068 § 3512012112-144 [Sec.] 707(a)126 Stat. 1068 § 351nt new2012112-144 [Sec.] 608(b)(3)126 Stat. 1059 § 3512012112-144 [Sec.] 608(b)(2)126 Stat. 1058 This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.20 CFR - Title 20—Employees' Benefits20 CFR 20720 CFR 20820 CFR 209 - RAILROAD EMPLOYERS' REPORTS AND RESPONSIBILITIES20 CFR 210 - CREDITABLE RAILROAD SERVICE20 CFR 211 - CREDITABLE RAILROAD COMPENSATION20 CFR 212 - MILITARY SERVICE20 CFR 216 - ELIGIBILITY FOR AN ANNUITY20 CFR 225 - PRIMARY INSURANCE AMOUNT DETERMINATIONS20 CFR 226 - COMPUTING EMPLOYEE, SPOUSE, AND DIVORCED SPOUSE ANNUITIES20 CFR 29920 CFR 300 - DEFINITIONS20 CFR 310
21 CFR - Food and Drugs21 CFR 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS21 CFR 3 - PRODUCT JURISDICTION21 CFR 5 - ORGANIZATION21 CFR 7 - ENFORCEMENT POLICY21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR 17 - CIVIL MONEY PENALTIES HEARINGS21 CFR 20 - PUBLIC INFORMATION21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY21 CFR 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS21 CFR 56 - INSTITUTIONAL REVIEW BOARDS21 CFR 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES21 CFR 70 - COLOR ADDITIVES21 CFR 71 - COLOR ADDITIVE PETITIONS21 CFR 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION21 CFR 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION21 CFR 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES21 CFR 200 - GENERAL21 CFR 201 - LABELING21 CFR 203 - PRESCRIPTION DRUG MARKETING21 CFR 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS21 CFR 328 - OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL21 CFR 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED21 CFR 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE21 CFR 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
31 CFR - Title 31—Money and Finance: Treasury31 CFR 31431 CFR 315 - REGULATIONS GOVERNING U.S. SAVINGS BONDS, SERIES A, B, C, D, E, F, G, H, J, AND K, AND U.S. SAVINGS NOTES31 CFR 32031 CFR 346 - REGULATIONS GOVERNING UNITED STATES INDIVIDUAL RETIREMENT BONDS31 CFR 347 - 31 CFR 348 - REGULATIONS GOVERNING DEPOSITARY COMPENSATION SECURITIES31 CFR 34931 CFR 35031 CFR 352 - OFFERING OF UNITED STATES SAVINGS BONDS, SERIES HH31 CFR 355 - REGULATIONS GOVERNING FISCAL AGENCY CHECKS31 CFR 357 - REGULATIONS GOVERNING BOOK-ENTRY TREASURY BONDS, NOTES AND BILLS HELD IN LEGACY TREASURY DIRECT31 CFR 358 - REGULATIONS GOVERNING BOOK-ENTRY CONVERSION OF BEARER CORPORA AND DETACHED BEARER COUPONS
33 CFR - Title 33—Navigation and Navigable Waters33 CFR 34033 CFR 34133 CFR 34333 CFR 344 57033 CFR 57133 CFR 60033 CFR 61033 CFR 61633 CFR 64033 CFR 66033 CFR 814
36 CFR - Title 36—Parks, Forests, and Public Property36 CFR 36936 CFR 50036 CFR 511 - 36 CFR 51436 CFR 530 - CLAIMS AGAINST THE SMITHSONIAN INSTITUTION INCLUDING THE NATIONAL GALLERY OF ART, THE JOHN F. KENNEDY CENTER FOR THE PERFORMING ARTS AND THE WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS36 CFR 60136 CFR 60636 CFR 60736 CFR 63036 CFR 68036 CFR 70036 CFR 800 - PROTECTION OF HISTORIC PROPERTIES
80 CFR - 80 CFR 80780 CFR 80980 CFR 81080 CFR 81280 CFR 82080 CFR 82180 CFR 86180 CFR 86280 CFR 86480 CFR 86680 CFR 86880 CFR 870
87 CFR - 87 CFR 87487 CFR 87687 CFR 87887 CFR 88087 CFR 88287 CFR 88487 CFR 88687 CFR 88887 CFR 89087 CFR 89287 CFR 898
101 CFR - Title 101101 CFR 1020101 CFR 1030101 CFR 1040101 CFR 1050