21 USC 374 - Inspection

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (a)(5), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2022—Subsec. (a)(1). Puspan. L. 117–328, § 3611(a), substituted “devices” for “restricted devices” in two places.

Puspan. L. 117–328, § 3504, inserted “In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364span, and 364f of this title, when the standard for records inspection under such section applies.” after “limitations established in section 350c(d) of this title.”

Subsec. (a)(4)(A). Puspan. L. 117–328, § 3611(span)(1), substituted “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),” for “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and “records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.” for “records requested.”

Subsec. (a)(4)(C), (D). Puspan. L. 117–328, § 3613(span), added subpar. (C) and redesignated former subpar. (C) as (D).

Subsec. (a)(5). Puspan. L. 117–328, § 3612(a), added par. (5).

Subsec. (span). Puspan. L. 117–328, § 2515(a)(2), made technical amendment to directory language of Puspan. L. 116–136, § 3112(d)(1). See 2020 Amendment note below.

Subsec. (g)(11). Puspan. L. 117–328, § 3106, substituted “October 1, 2027” for “December 24, 2022”.

Puspan. L. 117–229 substituted “December 24, 2022” for “December 17, 2022”.

Puspan. L. 117–180 substituted “December 17” for “October 1”.

2020—Subsec. (span). Puspan. L. 116–136, § 3112(d)(1), as amended by Puspan. L. 117–328, § 2515(a)(2), designated existing provisions as par. (1), redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).

2017—Subsec. (g)(11). Puspan. L. 115–52, § 703, substituted “October 1, 2022” for “October 1, 2017”.

Subsec. (g)(15). Puspan. L. 115–52, § 705, added par. (15).

Subsec. (h). Puspan. L. 115–52, § 702(a), added subsec. (h).

2012—Subsec. (a)(4). Puspan. L. 112–144, § 706, added par. (4).

Subsec. (g)(11). Puspan. L. 112–144, § 612, substituted “October 1, 2017” for “October 1, 2012”.

2011—Subsec. (a)(1). Puspan. 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 intent of Congress.

2009—Subsec. (a)(1). Puspan. 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”.

Puspan. L. 111–31, § 103(i)(1)(B), substituted “restricted devices, or tobacco products” for “or restricted devices” in two places.

Subsec. (a)(1)(A). Puspan. L. 111–31, § 103(i)(1)(A), substituted “devices, tobacco products, or cosmetics” for “devices, or cosmetics” in two places.

Subsec. (span). Puspan. L. 111–31, § 103(i)(2), inserted “tobacco product,” after “device,”.

Subsec. (g)(13). Puspan. 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.

2007—Subsec. (g)(1). Puspan. L. 110–85, § 228(1), substituted “The Secretary” for “Not later than one year after October 26, 2002, the Secretary”.

Subsec. (g)(2). Puspan. 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). Puspan. L. 110–85, § 228(3), added subpars. (F) and (G).

Subsec. (g)(6). Puspan. L. 110–85, § 228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C).

Subsec. (g)(7)(A). Puspan. 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). Puspan. L. 110–85, § 228(5)(B), added subpar. (F).

Subsec. (g)(10)(C)(iii). Puspan. L. 110–85, § 228(6), substituted “base amount applicable” for “based amount applicable”.

2004—Subsec. (g)(1). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(1)(C)(ii)(II), substituted “an accredited person” for “such a person”.

Subsec. (g)(6)(A)(iii). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(1)(C)(iii)(III), inserted “or by a person accredited under paragraph (2)” after “by the Secretary”.

Subsec. (g)(6)(A)(iv)(I). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II).

Subsec. (g)(6)(C)(ii). Puspan. L. 108–214, § 2(span)(1)(F), struck out “in accordance with section 360(h) of this title, or has not during such period been inspected pursuant to section 360(i) of this title, as applicable” after “inspected by the Secretary”.

Subsec. (g)(10)(B)(iii). Puspan. L. 108–214, § 2(span)(1)(G), substituted “a report” for “a reporting”.

Subsec. (g)(12)(A). Puspan. L. 108–214, § 2(span)(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). Puspan. L. 108–214, § 2(span)(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;”.

2002—Subsec. (a)(1). Puspan. L. 107–188, § 306(span)(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). Puspan. L. 107–188, § 306(span)(2), substituted “third sentence” for “second sentence” in introductory provisions.

Subsec. (f)(1). Puspan. L. 107–250, § 201(span)(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). Puspan. L. 107–250, § 201(span)(2), substituted “an accredited person described in paragraph (3)” for “a person accredited under section 360m of this title”.

Subsec. (f)(3). Puspan. L. 107–250, § 201(span)(3), added par. (3).

Subsec. (g). Puspan. L. 107–250, § 201(a), added subsec. (g).

1997—Subsec. (a)(1). Puspan. L. 105–115, § 412(span), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places.

Puspan. L. 105–115, § 125(span)(2)(L), struck out “, section 357(d) or (g),” before “section 360i”.

Subsec. (f). Puspan. L. 105–115, § 210(span), added subsec. (f).

1993—Subsec. (a)(1). Puspan. 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)”.

1980—Subsec. (a)(1). Puspan. 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). Puspan. 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). Puspan. L. 96–359, § 4(4), added par. (3).

1976—Subsec. (a). Puspan. 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). Puspan. L. 94–295, § 6(d), added subsec. (e).

1962—Subsec. (a). Puspan. 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. (span). Puspan. L. 87–781, § 201(span), inserted “consulting laboratory” after “warehouse”.

1953—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. (span) to (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2020 Amendment

Amendment by Puspan. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Puspan. L. 116–136, set out as a note under section 356c of this title.

Effective Date of 1997 Amendment

Amendment by sections 210(span) and 412(span) of Puspan. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Puspan. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1962 Amendment

Amendment by Puspan. L. 87–781 effective Oct. 10, 1962, see section 203 of Puspan. L. 87–781, set out as a note under section 332 of this title.

Construction of 2011 Amendment

Nothing in amendment by Puspan. 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.

Review of Processes and Practices; Guidance for Industry

Puspan. L. 117–328, div. FF, title III, § 3612(span), Dec. 29, 2022, 136 Stat. 5871, provided that:

“(1)In general.—The Secretary [of Health and Human Services] shall—

“(A) review processes and practices in effect as of the date of enactment of this Act [Dec. 29, 2022] applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(a)(5)], as added by subsection (a); and

“(B) evaluate whether any updates are needed to facilitate the consistency of such processes and practices.

“(2)Guidance.—

“(A)In general.—The Secretary shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspections.

“(B)Timing.—The Secretary shall—

“(i) not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and

“(ii) not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A).”

Unannounced Foreign Facility Inspections Pilot Program

Puspan. L. 117–328, div. FF, title III, § 3615, Dec. 29, 2022, 136 Stat. 5873, provided that:

“(a)In General.—The Secretary [of Health and Human Services] shall conduct a pilot program under which the Secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection. Such pilot program shall evaluate—

“(1) differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection;

“(2) costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;

“(3) barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and

“(4) approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.

“(span)Pilot Program Scope.—The inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections conducted as part of the Secretary’s evaluation of a request for approval to market a drug submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.).

“(c)Pilot Program Initiation.—The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act [Dec. 29, 2022].

“(d)Report.—The Secretary shall, not later than 180 days following the completion of the pilot program under this section, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including—

“(1) findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments;

“(2) findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and

“(3) the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act.”

Guidance

Puspan. L. 117–328, div. FF, title III, § 3611(span)(2), Dec. 29, 2022, 136 Stat. 5869, provided that:

“(A)In general.—The Secretary [of Health and Human Services] shall issue or update guidance describing—

“(i) circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(a)(4)], as amended by paragraph (1);

“(ii) processes for responding to such requests electronically or in physical form; and

“(iii) factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.

“(B)Timing.—The Secretary shall—

“(i) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], issue draft guidance under subparagraph (A); and

“(ii) not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A).”

Puspan. L. 115–52, title VII, § 702(span), Aug. 18, 2017, 131 Stat. 1055, provided that:

“(1)Draft guidance.—Not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that—

“(A) specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), and the requirements described in paragraph (2) of such subsection (h);

“(B) provides for standardized methods for communications described in such paragraphs;

“(C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360(h)(2)], as amended by subsection (a) [of section 701 of Puspan. L. 115–52]), a standard timeframe for such inspections—

“(i) that occurs over consecutive days; and

“(ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and

“(D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

“(2)Final guidance.—Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a).”

Inspections

Puspan. L. 115–52, title VIII, § 806, Aug. 18, 2017, 131 Stat. 1073, provided that:

“Within 6 months of the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall—

“(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)—

“(A) for which the approval is dependent upon remediation of conditions identified in the report;

“(B) for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and

“(C) where the drug that is the subject of the application is a drug—

“(i) for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or

“(ii) that is included on the list under section 506E of such Act (21 U.S.C. 356e);

“(2) address expedited re-inspection of facilities, as appropriate; and

“(3) establish a 6-month timeline for completion of review of such responses to such reports.”

Authority of Secretary Prior to October 10, 1962

Puspan. L. 87–781, title II, § 201(d), Oct. 10, 1962, 76 Stat. 793, provided that: “Nothing in the amendments made by subsections (a) and (span) of this section [amending this section] shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act [Oct. 10, 1962].”

Executive Documents

Transfer of Functions

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.