United States Government Printing Office printer prt distributor dst United States Congress House of Representatives Office of the Law Revision Counsel author aut Government Organization text government publication eng USCODE Bills and Statutes 2006_uscode_suppl_4 legislative 2011-09-06 Sec. 374 D09002ee180df8153-USCODE-2010-title21-chap9-subchapVII-partA-sec374.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapVII-partA-sec374.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partA-sec374 21USC374 http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partA-sec374/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapVII-partA-sec374.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVII-partA-sec374.htm 21 U.S.C. 374 21 USC 374 21 U.S.C. 374 21 USC 374; FOOD AND DRUGS; Inspection 261 LEAF USCODE-2010-title21-chap9-subchapVII-partA-sec374 Sec. 374 section standard June 25, 1938, ch. 675, §704, 52 Stat. 1057; Aug. 7, 1953, ch. 350, §1, 67 Stat. 476; Pub. L. 87-781, title II, §201(a), (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, §6, May 28, 1976, 90 Stat. 581; Pub. L. 96-359, §4, Sept. 26, 1980, 94 Stat. 1193; Pub. L. <!-- PDFPage:315 -->103-80, §3(aa), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, §125(b)(2)(L), title II, §210(b), title IV, §412(b), Nov. 21, 1997, 111 Stat. 2326, 2344, 2375; Pub. L. 107-188, title III, §306(b), June 12, 2002, 116 Stat. 670; Pub. L. 107-250, title II, §201(a), (b), Oct. 26, 2002, 116 Stat. 1602, 1609; Pub. L. 108-214, §2(b)(1), Apr. 1, 2004, 118 Stat. 573; Pub. L. 110-85, title II, §228, Sept. 27, 2007, 121 Stat. 855; Pub. L. 111-31, div. A, title I, §103(i), June 22, 2009, 123 Stat. 1837; Pub. L. 111-353, title I, §101(b), Jan. 4, 2011, 124 Stat. 3887. amendments <b>2011</b>-Subsec. (a)(1). Pub. L. 111-353, which directed the amendment of subsec. (a)(1)(B) by substituting “section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to” for “section 350c of this title when” and all that follows through “subject to”, was executed by making the substitution for “section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to” in the sentence following subpar. (B) of subsec. (a)(1), to reflect the probable inent of Congress.<b>2009</b>-Subsec. (a)(1). Pub. L. 111-31, §103(i)(1)(C), substituted “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products” for “and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) section 360i, or 360j(g) of this title, and data relating to other drugs or devices”.Pub. L. 111-31, §103(i)(1)(B), substituted “restricted devices, or tobacco products” for “or restricted devices” in two places.Subsec. (a)(1)(A). Pub. L. 111-31, §103(i)(1)(A), substituted “devices, tobacco products, or cosmetics” for “devices, or cosmetics” in two places.Subsec. (b). Pub. L. 111-31, §103(i)(2), inserted “tobacco product,” after “device,”.Subsec. (g)(13). Pub. L. 111-31, §103(i)(3), made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.<b>2007</b>-Subsec. (g)(1). Pub. L. 110-85, §228(1), substituted “The Secretary” for “Not later than one year after October 26, 2002, the Secretary”.Subsec. (g)(2). Pub. L. 110-85, §228(2), substituted “The Secretary” for “Not later than 180 days after October 26, 2002, the Secretary” and struck out at end “In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1).”Subsec. (g)(3)(F), (G). Pub. L. 110-85, §228(3), added subpars. (F) and (G).Subsec. (g)(6). Pub. L. 110-85, §228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C).Subsec. (g)(7)(A). Pub. L. 110-85, §228(5)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: “Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report (including for inspections classified as ‘no action indicated’) in a form and manner consistent with such reports prepared by employees and officials designated by the Secretary to conduct inspections.”Subsec. (g)(7)(F). Pub. L. 110-85, §228(5)(B), added subpar. (F).Subsec. (g)(10)(C)(iii). Pub. L. 110-85, §228(6), substituted “base amount applicable” for “based amount applicable”.<b>2004</b>-Subsec. (g)(1). Pub. L. 108-214, §2(b)(1)(A), in first sentence, substituted “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title.” for “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 360(h) of this title, or inspections of such establishments required to register pursuant to section 360(i) of this title.”Subsec. (g)(5)(B). Pub. L. 108-214, §2(b)(1)(B), in first sentence, substituted “poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection.” for “or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection.”Subsec. (g)(6)(A)(i). Pub. L. 108-214, §2(b)(1)(C)(i), substituted “described in paragraph (1)” for “of the establishment pursuant to subsection (h) or (i) of section 360 of this title”.Subsec. (g)(6)(A)(ii). Pub. L. 108-214, §2(b)(1)(C)(ii)(I), substituted “inspections” for “each inspection” and inserted “during a 2-year period” after “person” in introductory provisions.Subsec. (g)(6)(A)(ii)(I). Pub. L. 108-214, §2(b)(1)(C)(ii)(II), substituted “an accredited person” for “such a person”.Subsec. (g)(6)(A)(iii). Pub. L. 108-214, §2(b)(1)(C)(iii)(I), substituted “and 1 or both of the following additional conditions are met:” for “and the following additional conditions are met:” in introductory provisions.Subsec. (g)(6)(A)(iii)(I). Pub. L. 108-214, §2(b)(1)(C)(iii)(II), substituted “(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments.” for “accredited under paragraph (2) and identified under subclause (II) of this clause.”Subsec. (g)(6)(A)(iii)(II). Pub. L. 108-214, §2(b)(1)(C)(iii)(III), inserted “or by a person accredited under paragraph (2)” after “by the Secretary”.Subsec. (g)(6)(A)(iv)(I). Pub. L. 108-214, §2(b)(1)(C)(iv), in first sentence, inserted “section” after “pursuant to” and substituted “inspections of the establishment during the previous 4 years” for “the two immediately preceding inspections of the establishment”, in third sentence, struck out “the petition states a commercial reason for the waiver;” after “granted only if” and inserted “not” after “the Secretary has not determined that the public health would”, and, in last sentence, substituted “granted or deemed to be granted until” for “granted until”.Subsec. (g)(6)(A)(iv)(II). Pub. L. 108-214, §2(b)(1)(C)(v), inserted “of a device establishment required to register” after “to be conducted” and “section” after “pursuant to”.Subsec. (g)(6)(B)(iii). Pub. L. 108-214, §2(b)(1)(D), in first sentence, substituted “and with other” for “,and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this title and other” and, in second sentence, substituted “inspectional findings” for “inspections” and inserted “relevant” after “together with all other”.Subsec. (g)(6)(B)(iv). Pub. L. 108-214, §2(b)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II).Subsec. (g)(6)(C)(ii). Pub. L. 108-214, §2(b)(1)(F), struck out “in accordance with section 360(h) of this title, or has not during such period been inspected pur<!-- PDFPage:316 -->suant to section 360(i) of this title, as applicable” after “inspected by the Secretary”.Subsec. (g)(10)(B)(iii). Pub. L. 108-214, §2(b)(1)(G), substituted “a report” for “a reporting”.Subsec. (g)(12)(A). Pub. L. 108-214, §2(b)(1)(H)(i), added subpar. (A) and struck out former subpar. (A) which read as follows: “the number of inspections pursuant to subsections (h) and (i) of section 360 of this title conducted by accredited persons and the number of inspections pursuant to such subsections conducted by Federal employees;”.Subsec. (g)(12)(E). Pub. L. 108-214, §2(b)(1)(H)(ii), substituted “obtained by the Secretary pursuant to inspections conducted by Federal employees;” for “obtained by the Secretary pursuant to subsection (h) or (i) of section 360 of this title;”.<b>2002</b>-Subsec. (a)(1). Pub. L. 107-188, §306(b)(1), inserted after first sentence “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title.”Subsec. (a)(2). Pub. L. 107-188, §306(b)(2), substituted “third sentence” for “second sentence” in introductory provisions.Subsec. (f)(1). Pub. L. 107-250, §201(b)(1), in first sentence, substituted “An accredited person described in paragraph (3) shall maintain records” for “A person accredited under section 360m of this title to review reports made under section 360(k) of this title and make recommendations of initial classifications of devices to the Secretary shall maintain records”.Subsec. (f)(2). Pub. L. 107-250, §201(b)(2), substituted “an accredited person described in paragraph (3)” for “a person accredited under section 360m of this title”.Subsec. (f)(3). Pub. L. 107-250, §201(b)(3), added par. (3).Subsec. (g). Pub. L. 107-250, §201(a), added subsec. (g).<b>1997</b>-Subsec. (a)(1). Pub. L. 105-115, §412(b), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places.Pub. L. 105-115, §125(b)(2)(L), struck out “,section 357(d) or (g),” before “section 360i”.Subsec. (f). Pub. L. 105-115, §210(b), added subsec. (f).<b>1993</b>-Subsec. (a)(1). Pub. L. 103-80 substituted a comma for semicolon after “finished and unfinished materials” and “section 355(i) or (k)” for “section 355(i) or (j)”.<b>1980</b>-Subsec. (a)(1). Pub. L. 96-359, §4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, inserted reference to paragraph (3) and substituted “(A)” and “(B)” for “(1)” and “(2)”, respectively.Subsec. (a)(2). Pub. L. 96-359, §4(3), redesignated sixth sentence of former subsec. (a) as par. (2) and, as so redesignated, substituted reference to second sentence of paragraph (1) for reference to former second sentence of this subsection, and “(A)”, “(B)”, “(C)”, and “(D)”, for “(1)”, “(2)”, “(3)”, and “(4)”, respectively.Subsec. (a)(3). Pub. L. 96-359, §4(4), added par. (3).<b>1976</b>-Subsec. (a). Pub. L. 94-295, §6(a)-(c), expanded existing provisions to encompass medical devices by inserting references to factories, warehouses, establishments, and consulting laboratories in which restricted devices are manufactured, processed, packed, or held, inspections relating to devices, reporting and inspection regulations issued pursuant to sections 360i and 360j(g) of this title, and the manufacture and processing of devices.Subsec. (e). Pub. L. 94-295, §6(d), added subsec. (e).<b>1962</b>-Subsec. (a). Pub. L. 87-781, §201(a), extended the inspection, where prescription drugs are manufactured, processed, packed, or held, to all things bearing on whether adulterated or misbranded drugs, or any which may not be manufactured, introduced in interstate commerce, or sold or offered for sale under any provision of this chapter, have been or are being manufactured, processed, packed, transported or held in any such place, or otherwise bearing on violation of this chapter, but excluded from such inspection, data concerning finance, sales other than shipment, pricing, personnel other than qualifications of technical and professional personnel, research other than relating to new drugs subject to reporting, provided that provisions of second sentence of this subsection shall be inapplicable to pharmacies, practitioners and other persons enumerated in pars. (1) to (4), and struck out “are held” before “after such introduction”.Subsec. (b). Pub. L. 87-781, §201(b), inserted “consulting laboratory” after “warehouse”.<b>1953</b>-Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by substituting provisions permitting entry and inspection upon presentation of appropriate credentials and a written notice to the owner, operator, or agent in charge for provisions which authorized entry and inspection only after making a request and obtaining permission from the owner, operator, or custodian, and inserting provisions requiring a separate written notice for each inspection but not for each entry made during the period covered by the inspection, and directing that the inspection shall be conducted within reasonable limits, in a reasonable manner and completed with reasonable promptness, and added subsecs. (b) to (d). effectiveDate amendments Amendment by sections 210(b) and 412(b) of 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 a note under section 321 of this title.Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section 203 of Pub. L. 87-781, set out as a note under section 332 of this title. construction amendments Nothing in amendment by Pub. L. 111-353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. transferOfFunctions 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. false false false Part A General Administrative Provisions Volume 52 Page 1057 52 Stat. 1057 Volume 67 Page 476 67 Stat. 476 Volume 76 Page 792 76 Stat. 792 Volume 90 Page 581 90 Stat. 581 Volume 94 Page 1193 94 Stat. 1193 Volume 107 Page 778 107 Stat. 778 Volume 111 Page 2326 111 Stat. 2326 Volume 116 Page 670 Volume 116 Page 1602 116 Stat. 670 116 Stat. 1602 Volume 118 Page 573 118 Stat. 573 Volume 121 Page 855 121 Stat. 855 Volume 123 Page 1837 123 Stat. 1837 Volume 124 Page 3887 124 Stat. 3887 Public Law 87-781 Public Law 87-781 Public Law 94-295 Public Law 94-295 Public Law 96-359 Public Law 96-359 Public Law 103-80 Public Law 105-115 Public Law 105-115 Public Law 107-188 Public Law 107-188 Public Law 107-250 Public Law 107-250 Public Law 108-214 Public Law 108-214 Public Law 110-85 Public Law 110-85 Public Law 111-31 Public Law 111-31 Public Law 111-353 Public Law 111-353 U.S. Government Printing Office 2010-12-31 monographic 2010 annual deposited born digital 711 p. Y 1.2/5: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21 P0b002ee180df746e 000645501 21USC DGPO 2011-09-06 2011-09-06 USCODE-2010-title21 machine generated eng fdlp USCODE USCODE-2010-title21 21 true 4 2006 false false 2011-01-07 false false USCODE-title21 Title 21 http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21.htm http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21.pdf U.S.C. Title 21, 2010