21 U.S.C. § 372 — Examinations and investigations

Page 493 TITLE 21—FOOD AND DRUGS § 372 ‘‘(d) COLLABORATION.—The Secretary shall implement programs and policies that will foster collaboration be- tween the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supple- mental applications or conduct further research in sup- port of a supplemental application based, in whole or in part, on such studies.’’ HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, re- garding food standards, see Savings Provisions note set out under section 341 of this title. Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator 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. § 372. Examinations and investigations (a) Authority to conduct (1)(A) The Secretary is authorized to conduct examinations and investigations for the pur- poses of this chapter through officers and em- ployees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision there- of, duly commissioned by the Secretary as an of- ficer of the Department. (B)(i) For a tobacco product, to the extent fea- sible, 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 enforce- ment 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 Sec- retary and the head of another Federal depart- ment or agency, is authorized to conduct exami- nations 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 in- clude provisions to ensure adequate training of such officers and employees to conduct the ex- aminations and investigations. The memo- randum of understanding shall contain provi- sions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimburse- ment, in whole or in part, from the Secretary for the examinations or investigations per- formed under this section by the officers or em- ployees of the other department or agency. (B) A memorandum of understanding under subparagraph (A) between the Secretary and an- other 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 under- standing 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 jurisdic- tion (authorizing and appropriating) in the House of Representatives and the Senate a re- port 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 pursu- ant to such memorandum. (3) In the case of food packed in the Common- wealth of Puerto Rico or a Territory the Sec- retary 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 sam- ples 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 regu- lations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this sub- section as he finds necessary for the proper ad- ministration of the provisions of this chapter. (c) Records of other departments and agencies For purposes of enforcement of this chapter, records of any department or independent estab- lishment in the executive branch of the Govern- ment shall be open to inspection by any official of the Department duly authorized by the Sec- retary 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 re- spect to such questions relating to drugs as the Director may submit concerning any patent ap- plication. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required. Page 494 TITLE 21—FOOD AND DRUGS § 372a (e) Powers of enforcement personnel Any officer or employee of the Department designated by the Secretary to conduct exami- nations, 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 ar- rest warrants; (3) execute seizure by process issued pursu- ant to libel under section 334 of this title; (4) make arrests without warrant for of- fenses under this chapter with respect to such drugs if the offense is committed in his pres- ence or, in the case of a felony, if he has prob- able cause to believe that the person so ar- rested 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, label- ing, or other things, if they are, or he has rea- sonable grounds to believe that they are, sub- ject to seizure and condemnation under such section 334(a)(2). In the event of seizure pursu- ant to this paragraph (5), libel proceedings under section 334(a)(2) of this title shall be in- stituted 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 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 sub- section,’’ for ‘‘For the purposes of this subsection’’. 1999—Subsec. (d). Pub. L. 106–113, in first sentence, substituted ‘‘Under Secretary of Commerce for Intel- lectual Property and Director of the United States Pat- ent and Trademark Office’’ for ‘‘Commissioner of Pat- ents’’ and ‘‘Director’’ for ‘‘Commissioner’’. 1993—Subsec. (c). Pub. L. 103–80 struck out ‘‘of Agri- culture’’ 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 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 com- menced 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 Admin- istrator 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 sec- tion 321 of this title. § 372a. Transferred Editorial Notes CODIFICATION Section, act June 25, 1938, ch. 675, § 702A, formerly June 30, 1906, ch. 3915, § 10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to exam- ination of sea food, was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, § 106(3), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 376 of this title. § 373. Records (a) In general For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate com- merce, and persons receiving food, drugs, de- vices, tobacco products, or cosmetics in inter- state commerce or holding such articles so re- ceived, shall, upon the request of an officer or employee duly designated by the Secretary, per- mit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so re- quested when such request is accompanied by a statement in writing specifying the nature or