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. § 379
Confidential information
(a) ContractorsThe Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in connection with an activity which is undertaken under contract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or employee of the Department) is not prohibited from using such information. The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may by regulation prescribe.
(b) Ability to receive and protect confidential information obtained from foreign governments(1) In generalThe Secretary shall not be required to disclose under section 552 of title 5 (commonly referred to as the “Freedom of Information Act”), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—(A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;(B) the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and(C) the information is covered by, and subject to, a written agreement between the Secretary and the foreign government.(2) Time limitationsThe written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.
(3) Disclosures not affectedNothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.
(4) Relation to other lawFor purposes of section 552 of title 5, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552.
(c) Authority to enter into memoranda of understanding for purposes of information exchangeThe Secretary may enter into written agreements to provide information referenced in section 331(j) of this title to foreign governments subject to the following criteria:(1) CertificationThe Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.
(2) Written agreementThe written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 247d of title 42 that is relevant to the information.
(3) Information exchangeThe Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 331(j) of this title in only the following circumstances:(A) Information concerning the inspection of a facility may be provided to a foreign government if—(i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and(ii) the written agreement executed under paragraph (2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes.(B) Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.(4) Effect of subsectionNothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.
(June 25, 1938, ch. 675, § 708, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 582; amended Pub. L. 112–144, title VII, § 710, July 9, 2012, 126 Stat. 1070.)Editorial NotesAmendments2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).
Notes of Decisions
United States v. Torigian Labs., Inc., 577 F. Supp. 1514 (E.D.N.Y 1984).
“21 U.S.C. § 379 . Thus, the government was not required to prove that the devices, intraocular lenses, were shipped in interstate commerce in order to invoke the jurisdiction of this court.”
United States v. Vidal-Cruz, 67 F. Supp. 2d 35 (D.P.R. 1999).
· cites it 3× “2 DISCUSSION The government proposes three arguments in support of federal jurisdiction over this matter: 1) a presumption of jurisdiction pursuant to 21 U.S.C. § 379 (a); 2) that the addition of an ingredient that had been shipped in interstate commerce is sufficient to render…”
Sandoz, Inc. v. Leavitt, 427 F. Supp. 2d 29 (D.D.C. 2006).
“, 21 U.S.C. § 379 . 3. The Defendant’s Violation of 21 U.”
Solak v. Target Corp. (N.D.N.Y. 2023).
“All claims alleged in the Complaint are DISMISSED with prejudice inasmuch as “amendment would be futile because no amended complaint can change the fact [that] plaintiff's claim[s] [are] preempted under 21 U.S.C. § 379 (a)(2).” Novotney, 2023 WL 4698149 , at *5) (citing Abron at…”
Navarro v. Walgreens Boots All., Inc. (E.D. Cal. 2025).
“” 21 U.S.C. § 379 (c)(2). 2 OTC acne drug products, including Walgreens’ products, are governed by a 3 comprehensive set of FDA regulations called a monograph, which includes certain labeling 4 requirements.”
Pineda v. Lake Consum. Prods., Inc. (E.D. Pa. 2025).
“PREEMPTION Next, Lake argues that Pineda’s state law claims are preempted by the Food, Drug, and Cosmetic Act (“FDCA”), which prohibits states from establishing any requirement for over-the- counter (“OTC”) drugs “that is different from or in addition to, .”
United States v. Varela-Cruz, 66 F. Supp. 2d 274 (D.P.R. 1999).
· cites it 2× “The specific allegations are that this court lacks jurisdiction because: (1) there has been no showing that milk provided by Defendants was distributed into the stream of interstate commerce; (2) there is no federal jurisdiction because the jurisdiction presumption stated in 21…”
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