
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC374]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                    SUBCHAPTER VII--GENERAL AUTHORITY
 
                Part A--General Administrative Provisions
 
Sec. 374. Inspection


(a) Right of agents to enter; scope of inspection; notice; promptness; 
        exclusions

    (1) For purposes of enforcement of this chapter, officers or 
employees duly designated by the Secretary, upon presenting appropriate 
credentials and a written notice to the owner, operator, or agent in 
charge, are authorized (A) to enter, at reasonable times, any factory, 
warehouse, or establishment in which food, drugs, devices, or cosmetics 
are manufactured, processed, packed, or held, for introduction into 
interstate commerce or after such introduction, or to enter any vehicle 
being used to transport or hold such food, drugs, devices, or cosmetics 
in interstate commerce; and (B) to inspect, at reasonable times and 
within reasonable limits and in a reasonable manner, such factory, 
warehouse, establishment, or vehicle and all pertinent equipment, 
finished and unfinished materials, containers, and labeling therein. In 
the case of any factory, warehouse, establishment, or consulting 
laboratory in which prescription drugs, nonprescription drugs intended 
for human use, or restricted devices are manufactured, processed, 
packed, or held, the inspection shall extend to all things therein 
(including records, files, papers, processes, controls, and facilities) 
bearing on whether prescription drugs, nonprescription drugs intended 
for human use, or restricted devices which are adulterated or misbranded 
within the meaning of this chapter, or which may not be manufactured, 
introduced into interstate commerce, or sold, or offered for sale by 
reason of 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. No inspection 
authorized by the preceding sentence or by paragraph (3) shall extend to 
financial data, sales data other than shipment data, pricing data, 
personnel data (other than data as to qualification of technical and 
professional personnel performing functions subject to this chapter), 
and research data (other than data relating to new drugs, antibiotic 
drugs, and devices and subject to reporting and inspection under 
regulations lawfully issued pursuant to section 355(i) or (k) \1\ 
section 360i, or 360j(g) of this title, and data relating to other drugs 
or devices which in the case of a new drug would be subject to reporting 
or inspection under lawful regulations issued pursuant to section 355(j) 
of this title). A separate notice shall be given for each such 
inspection, but a notice shall not be required for each entry made 
during the period covered by the inspection. Each such inspection shall 
be commenced and completed with reasonable promptness.
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    \1\ So in original. Probably should be followed by a comma.
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    (2) The provisions of the second sentence of paragraph (1) shall not 
apply to--
        (A) pharmacies which maintain establishments in conformance with 
    any applicable local laws regulating the practice of pharmacy and 
    medicine and which are regularly engaged in dispensing prescription 
    drugs or devices, upon prescriptions of practitioners licensed to 
    administer such drugs or devices to patients under the care of such 
    practitioners in the course of their professional practice, and 
    which do not, either through a subsidiary or otherwise, manufacture, 
    prepare, propagate, compound, or process drugs or devices for sale 
    other than in the regular course of their business of dispensing or 
    selling drugs or devices at retail;
        (B) practitioners licensed by law to prescribe or administer 
    drugs, or prescribe or use devices, as the case may be, and who 
    manufacture, prepare, propagate, compound, or process drugs, or 
    manufacture or process devices, solely for use in the course of 
    their professional practice;
        (C) persons who manufacture, prepare, propagate, compound, or 
    process drugs or manufacture or process devices, solely for use in 
    research, teaching, or chemical analysis and not for sale;
        (D) such other classes of persons as the Secretary may by 
    regulation exempt from the application of this section upon a 
    finding that inspection as applied to such classes of persons in 
    accordance with this section is not necessary for the protection of 
    the public health.

    (3) An officer or employee making an inspection under paragraph (1) 
for purposes of enforcing the requirements of section 350a of this title 
applicable to infant formulas shall be permitted, at all reasonable 
times, to have access to and to copy and verify any records--
        (A) bearing on whether the infant formula manufactured or held 
    in the facility inspected meets the requirements of section 350a of 
    this title, or
        (B) required to be maintained under section 350a of this title.

(b) Written report to owner; copy to Secretary

    Upon completion of any such inspection of a factory, warehouse, 
consulting laboratory, or other establishment, and prior to leaving the 
premises, the officer or employee making the inspection shall give to 
the owner, operator, or agent in charge a report in writing setting 
forth any conditions or practices observed by him which, in his 
judgment, indicate that any food, drug, device, or cosmetic in such 
establishment (1) consists in whole or in part of any filthy, putrid, or 
decomposed substance, or (2) has been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with 
filth, or whereby it may have been rendered injurious to health. A copy 
of such report shall be sent promptly to the Secretary.

(c) Receipt for samples taken

    If the officer or employee making any such inspection of a factory, 
warehouse, or other establishment has obtained any sample in the course 
of the inspection, upon completion of the inspection and prior to 
leaving the premises he shall give to the owner, operator, or agent in 
charge a receipt describing the samples obtained.

(d) Analysis of samples furnished owner

    Whenever in the course of any such inspection of a factory or other 
establishment where food is manufactured, processed, or packed, the 
officer or employee making the inspection obtains a sample of any such 
food, and an analysis is made of such sample for the purpose of 
ascertaining whether such food consists in whole or in part of any 
filthy, putrid, or decomposed substance, or is otherwise unfit for food, 
a copy of the results of such analysis shall be furnished promptly to 
the owner, operator, or agent in charge.

(e) Accessibility of records

    Every person required under section 360i or 360j(g) of this title to 
maintain records and every person who is in charge or custody of such 
records shall, upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable times to 
have access to, and to copy and verify, such records.

(f) Recordkeeping

    (1) 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 documenting the training qualifications of the person and the 
employees of the person, the procedures used by the person for handling 
confidential information, the compensation arrangements made by the 
person, and the procedures used by the person to identify and avoid 
conflicts of interest. Upon the request of an officer or employee 
designated by the Secretary, the person shall permit the officer or 
employee, at all reasonable times, to have access to, to copy, and to 
verify, the records.
    (2) Within 15 days after the receipt of a written request from the 
Secretary to a person accredited under section 360m of this title for 
copies of records described in paragraph (1), the person shall produce 
the copies of the records at the place designated by the Secretary.

(June 25, 1938, ch. 675, Sec. 704, 52 Stat. 1057; Aug. 7, 1953, ch. 350, 
Sec. 1, 67 Stat. 476; Pub. L. 87-781, title II, Sec. 201(a), (b), Oct. 
10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, Sec. 6, May 28, 1976, 90 
Stat. 581; Pub. L. 96-359, Sec. 4, Sept. 26, 1980, 94 Stat. 1193; Pub. 
L. 103-80, Sec. 3(aa), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, 
title I, Sec. 125(b)(2)(L), title II, Sec. 210(b), title IV, 
Sec. 412(b), Nov. 21, 1997, 111 Stat. 2326, 2344, 2375.)


                               Amendments

    1997--Subsec. (a)(1). Pub. L. 105-115, Sec. 412(b), substituted 
``prescription drugs, nonprescription drugs intended for human use,'' 
for ``prescription drugs'' in two places.
    Pub. L. 105-115, Sec. 125(b)(2)(L), struck out ``, section 357(d) or 
(g),'' before ``section 360i''.
    Subsec. (f). Pub. L. 105-115, Sec. 210(b), added subsec. (f).
    1993--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)''.
    1980--Subsec. (a)(1). Pub. L. 96-359, Sec. 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, Sec. 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, Sec. 4(4), added par. (3).
    1976--Subsec. (a). Pub. L. 94-295, Sec. 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, Sec. 6(d), added subsec. (e).
    1962--Subsec. (a). Pub. L. 87-781, Sec. 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, Sec. 201(b), 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. (b) to (d).


                    Effective Date of 1997 Amendment

    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.


                    Effective Date of 1962 Amendment

    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.

                          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 note set out under section 
41 of this title.


            Authority of Secretary Prior to October 10, 1962

    Section 201(d) of Pub. L. 87-781 provided that: ``Nothing in the 
amendments made by subsections (a) and (b) 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].''

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 334, 360, 360e, 360j, 
379l of this title.
