U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VII— GENERAL AUTHORITY › Part Part A— General Administrative Provisions

21 U.S.C. § 373

Records

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(a) In general

For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the request of an officer or employee duly designated by the Secretary, permit 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 requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, shall not be used in a criminal prosecution of the person from whom obtained, and except that carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b).

(b) Food transportation records

A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 350e of this title shall, on request of an officer or employee designated by the Secretary, permit the officer or employee, at reasonable times, to have access to and to copy all records that the Secretary requires to be kept under section 350e(c)(1)(E) of this title.

(June 25, 1938, ch. 675, § 703, 52 Stat. 1057; Pub. L. 91–452, title II, § 230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103–80, § 3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109–59, title VII, § 7202(c), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 111–31, div. A, title I, § 103(h), June 22, 2009, 123 Stat. 1837.)Editorial NotesAmendments

2009—Subsec. (a). Pub. L. 111–31 inserted “tobacco product,” after “device,” in two places and “tobacco products,” after “devices,” in two places.

2005—Pub. L. 109–59 struck out “of interstate shipment” after “Records” in section catchline, designated existing provisions as subsec. (a), inserted subsec. heading, substituted “carriers, except as provided in subsection (b)” for “carriers” before period at end, and added subsec. (b).

1993—Pub. L. 103–80 substituted “, except that” for “: Provided, That” and “, and except that” for “: Provided further, That”.

1970—Pub. L. 91–452 inserted “, or any evidence which is directly or indirectly derived from such evidence,” after “under this section”.

Statutory Notes and Related SubsidiariesEffective Date of 2005 Amendment

Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–452 effective on sixtieth day following Oct. 15, 1970, and not to affect any immunity to which any individual is entitled under this section by reason of any testimony given before sixtieth day following Oct. 15, 1970, see section 260 of Pub. L. 91–452, set out as an Effective Date; Savings Provision note under section 6001 of Title 18, Crimes and Criminal Procedure.

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 notes set out under section 321 of this title.

Notes of Decisions
Cited in 8 cases, 1948–2005 · leading case: United States v. Gel Spice Co., Inc.
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United States v. Gel Spice Co., Inc. (1985) nyed · cites it 13× “Suppression of Gel Spice Records The individual defendants have also moved under 21 U.S.C. § 373 to suppress records regarding the shipment and importation of certain foods.”
Wedgewood Village Pharmacy, Inc., in the Matter of Establishment Inspection Of: D/B/A Wedgewood Pharmacy v. United State (2005) ca3 “The defendant in Herold had argued that the FDA could only examine a pharmacy's records under a related provision, 21 U.S.C. § 373 , which permits inspection of records on the condition that the evidence obtained not be used in any subsequent prosecution.”
United States v. Crescent-Kelvan Co. (1948) ca3 “Since the right to inspect shipping records is not expressly conferred upon inspectors mating inspections of factories, it may be argued that .”
United States v. Herold (1955) nyed · cites it 3× “Another section of the Act, 21 U.S.C.A. § 373 , permits the inspectors to have ,ac *16 cess to copy documents, provided, however, that evidence, obtained pursuant to the said Section 373 shall not be used in a criminal prosecution of the person from whom it is obtained.”
Golden Grain MacAroni Co., Inc. v. United States (1953) ca9 “Compare also 21 U.S.C.A. §§ 373 and 331(e), and the language of the Fourth Circuit in United States v.”
National Confectioners Association v. Joseph A. Califano, Jr., Secretary of Health, Education and Welfare (1978) cadc “We acknowledge that 21 U.S.C. § 373 requires that only food carriers and recipients, not manufacturers, allow FDA officials to inspect records voluntarily kept in the exercise of business judgment.”
United States v. Lyon Drug Co. (1954) wied “Section 373 provides as follows: “For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, or cosmetics in interstate commerce or holding such árticles so received, shall, upon the request…”
Wedgewood Village v. United States (2005) ca3 “Wedgewood Is Not Entitled To The Records 9 The defendant in Herold had argued that the FDA could only examine a pharmacy’s records under a related provision, 21 U.S.C. § 373 , which permits inspection of records on the condition that the evidence obtained not be used in any…”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.