21 U.S.C. § 372

Examinations and investigations

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(a) Authority to conduct(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) Availability to owner of part of analysis samples

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.

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) Information on patents for drugs

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) Powers of enforcement personnelAny 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.(June 25, 1938, ch. 675, § 702, 52 Stat. 1056; Pub. L. 87–781, title III, §§ 307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L. 89–74, § 8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91–513, title II, § 701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102–300, § 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, § 3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106–113, div. B, § 1000(a)(9) [title IV, § 4732(b)(12)], Nov. 29, 1999, 113 Stat. 1536, 1501A–584; Pub. L. 107–188, title III, § 314, June 12, 2002, 116 Stat. 674; Pub. L. 111–31, div. A, title I, § 103(g), June 22, 2009, 123 Stat. 1837.)Editorial NotesAmendments

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 SubsidiariesEffective Date of 1999 Amendment

Amendment 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 Amendment

Amendment 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 Amendment

Amendment 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 DocumentsTransfer 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.

Notes of Decisions

Cited in 51 cases (2 in the last 5 years), 1944–2025 · leading case: Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001).

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Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). · cites it 2× “The FDA is empowered to investigate suspected fraud, see 21 U. S. C. § 372 ; 21 CFR § 5.35 (2000), and citizens may report wrongdoing and petition the agency to take action, § 10.”

Ass'n of Irritated Residents v. Env't Prot. Agency, 494 F.3d 1027 (D.C. Cir. 2007). · cites it 2× “In this case, the relevant statutes the Clean Air Act, CERCLA and EPCRA describe EPA's authority in similarly permissive terms. The Clean Air Act, for example, states in the primary federal enforcement provision that "whenever, on the basis of any information available to…”

PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010). “21 U.S.C. § 372 . The FDCA provides the FDA with a number of enforcement remedies that may be sought.”

Lofton v. McNeil Consum. & Specialty Pharm., 672 F.3d 372 (5th Cir. 2012). “Section 262 ), as amended; or (2) the warnings provided were those stated in monographs developed by the United States Food and Drug Administration for pharmaceutical products that may be distributed without an approved new drug application.”

Karen E. Cardoza v. Commodity Futures Trading Comm'n & Bd. of Trade of the City of Chicago, Inc., an Illinois Corp., 768 F.2d 1542 (7th Cir. 1985). “§ 12 (c)(2), which states that “[t]he [CFTC] may, in its discretion * * *, review any decision by an exchange whereby a person is suspended, expelled, otherwise disciplined or denied access to the exchange.”

All. to Save the Mattaponi v. United States Army Corps of Engineers, 515 F. Supp. 2d 1 (D.D.C. 2007). “2d 714 (1985) (interpreting the term "authorize” in § 372 of the Food, Drug and Cosmetic Act, 21 U.S.C. § 372 ). Further, common usage of the word “authorize” is understood to imply a discretionary delegation of duty.”

Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp. 3d 619 (W.D. Mich. 2015). “2d 854 (2001) (indicating that the FDA is empowered to investigate suspected fraud, see 21 U.S.C. § 372 ; 21 C.F.R. § 5.35 , and citizens may report wrongdoing and petition the agency to take action, § 10.”

In re Sichert, 566 F.2d 1154 (C.C.P.A. 1977). · cites it 2× “Moreover, the PTO did not request information or research on appellant’s compositions from the Secretary of Health, Education, and Welfare, which is specifically provided for in 21 U.S.C. § 372 (d). 7 b. Lack of Safety The Solicitor notes that the board did not reverse the…”

Stephen Wyden v. Comm'r of Patents & Trademarks, 807 F.2d 934 (Fed. Cir. 1986). “(15) 21 U.S.C. § 372 (access to PTO materials by Food and Drug Administration).”

Gonzalez v. Bayer Healthcare Pharm., Inc., 930 F. Supp. 2d 808 (S.D. Tex. 2013). “The FDA is responsible for policing fraud and “has the authority to investigate fraud, 21 U.S.C. § 372 , consider citizen petitions, 21 C.”

United States v. Roux Labs., Inc., 456 F. Supp. 973 (M.D. Fla. 1978). · cites it 2× “The Court will rule on the four issues raised by Roux, and then in a separate order rule on the specific objections raised by Roux. I. FDA’s Authority to Search and Collect Samples 21 U.”

Zimmerman v. Novartis Pharm. Corp., 889 F. Supp. 2d 757 (D. Maryland 2012). “1012 (citing 21 U.S.C. §§ 372 , 333, 334, 18 U.S.C. § 1001 ).”

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