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Title 21 — Food and DrugsRelease 119-73not60

§372 Examinations and Investigations

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions › § 372

Last updated Apr 5, 2026|Official source

Summary

Allows the Secretary to carry out inspections and investigations using Department staff or by commissioning state, territorial, or local health, food, or drug officers as Department officers. For tobacco products, the Secretary must, when possible, make contracts with States to inspect retailers, but cannot contract to enforce the law on Indian country without the written consent of the Indian tribe involved. The Secretary can also work with other federal agencies under a written agreement that must include training and reimbursement rules and only applies where both agencies share regulation of the place inspected. For any fiscal year when such agreements are used, the Secretary and the other agency head must send reports to the House and Senate committees that state: the number of officers or employees who took part, the number of additional articles inspected or examined, and the number of additional examinations or investigations done. The Secretary must try to inspect food packed in Puerto Rico or a Territory at the first U.S. entry point if facilities allow. The word “United States” here means the States and the District of Columbia. If a sample of food, drug, or cosmetic is taken, the Secretary must give part of the official sample for testing to anyone named on the label, the owner, or their attorney or agent on request, with reasonable exceptions or conditions by regulation. Records of any executive department or independent establishment must be open to inspection by Department officials the Secretary authorizes. At the request of the Under Secretary of Commerce for Intellectual Property and the USPTO Director, the Secretary must provide full information about drug questions related to patent applications and may do needed research. Department officers assigned to counterfeit drug work may, if authorized, carry firearms, serve search and arrest warrants, seize under section 334, make certain warrantless arrests, and make pre-libel seizures under section 334(a)(2) provided libel proceedings are started promptly and the court takes jurisdiction.

Full Legal Text

Title 21, §372

Food and Drugs — Source: USLM XML via OLRC

(a)(1)(A)The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department.
(B)(i)For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter.
(ii)The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved.
(2)(A)In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.
(B)A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.
(C)For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year—
(i)the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum;
(ii)the number of additional articles that were inspected or examined as a result of such memorandum; and
(iii)the number of additional examinations or investigations that were carried out pursuant to such memorandum.
(3)In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection.
(4)For the purposes of this subsection, the term “United States” means the States and the District of Columbia.
(b)Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter.
(c)For purposes of enforcement of this chapter, records of any department or independent establishment in the executive branch of the Government shall be open to inspection by any official of the Department duly authorized by the Secretary to make such inspection.
(d)The Secretary is authorized and directed, upon request from the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, to furnish full and complete information with respect to such questions relating to drugs as the Director may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required.
(e)Any officer or employee of the Department designated by the Secretary to conduct examinations, investigations, or inspections under this chapter relating to counterfeit drugs may, when so authorized by the Secretary—
(1)carry firearms;
(2)execute and serve search warrants and arrest warrants;
(3)execute seizure by process issued pursuant to libel under section 334 of this title;
(4)make arrests without warrant for offenses under this chapter with respect to such drugs if the offense is committed in his presence or, in the case of a felony, if he has probable cause to believe that the person so arrested has committed, or is committing, such offense; and
(5)make, prior to the institution of libel proceedings under section 334(a)(2) of this title, seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or he has reasonable grounds to believe that they are, subject to seizure and condemnation under such section 334(a)(2). In the event of seizure pursuant to this paragraph (5), libel proceedings under section 334(a)(2) of this title shall be instituted promptly and the property seized be placed under the jurisdiction of the court.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2009—Subsec. (a)(1). Pub. L. 111–31 designated existing provisions as subpar. (A) and added subpar. (B). 2002—Subsec. (a). Pub. L. 107–188 inserted “(1)” before “The Secretary is authorized to conduct”, added par. (2), inserted “(3)” before “In the case of food packed”, and substituted “(4) For the purposes of this subsection,” for “For the purposes of this subsection”. 1999—Subsec. (d). Pub. L. 106–113, in first sentence, substituted “Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office” for “Commissioner of Patents” and “Director” for “Commissioner”. 1993—Subsec. (c). Pub. L. 103–80 struck out “of Agriculture” after “Department”. 1992—Subsec. (c). Pub. L. 102–300, which directed the amendment of subsec. (c) by striking out “of Health, Education, and Welfare”, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and

Transfer of Functions

note below. 1970—Subsec. (e). Pub. L. 91–513 struck out reference to depressant or stimulant drugs. 1965—Subsec. (e). Pub. L. 89–74 added subsec. (e). 1962—Subsec. (a). Pub. L. 87–781, § 307(b), inserted “the Commonwealth of Puerto Rico or” before “a Territory the Secretary”. Subsec. (d). Pub. L. 87–781, § 308, added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date

of 1999 AmendmentAmendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, § 4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

Effective Date

of 1970 AmendmentAmendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an

Effective Date

note under section 801 of this title.

Effective Date

of 1965 AmendmentAmendment by Pub. L. 89–74 effective July 15, 1965, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the

Effective Date

of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now Drug

Enforcement

Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and

Regulations

in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

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 note set out under section 321 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 372

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60