---
kind: "section"
citation: "21 U.S.C. § 379"
title: "21"
title_heading: "Food and Drugs"
number: "379"
heading: "Confidential information"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part A — General Administrative Provisions"
---

# §379. Confidential information

- (a) **Contractors—** The [Secretary](/usc/21/321.md?p=d) may provide any information which is exempt from disclosure pursuant to subsection (a) of [section 552 of title 5](/usc/5/552.md) by reason of [subsection (b)(4)](/usc/5/552.md?p=b-4) of such section to a [person](/usc/21/321.md?p=e) other than an officer or employee of the [Department](/usc/21/321.md?p=c) if the [Secretary](/usc/21/321.md?p=d) determines such other [person](/usc/21/321.md?p=e) requires the information in connection with an activity which is undertaken under contract with the [Secretary](/usc/21/321.md?p=d), which relates to the administration of this chapter, and with respect to which the [Secretary](/usc/21/321.md?p=d) (or an officer or employee of the [Department](/usc/21/321.md?p=c)) is not prohibited from using such information. The [Secretary](/usc/21/321.md?p=d) shall require as a condition to the provision of information under this section that the [person](/usc/21/321.md?p=e) receiving it take such security precautions respecting the information as the [Secretary](/usc/21/321.md?p=d) may by regulation prescribe.
- (b) **Ability to receive and protect confidential information obtained from foreign governments—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall not be required to disclose under [section 552 of title 5](/usc/5/552.md) (commonly referred to as the “Freedom of Information Act”), or any other provision of law, any information relating to [drugs](/usc/21/321.md?p=g-1) obtained from a foreign government agency, if—
    - (A) the information concerns the inspection of a [facility](/usc/21/364.md?p=3-A), is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a [drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=d) and the foreign government.
  - (2) **Time limitations—** The written agreement described in [paragraph (1)(C)](#b-1-C) shall specify the time period for which [paragraph (1)](#b-1) shall apply to the voluntarily disclosed information. [Paragraph (1)](#b-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](/usc/5/552.md) and [section 247d–7e(e)(1) of title 42](/usc/42/247d–7e.md?p=e-1), as applicable, shall continue to apply to such information. If no date is specified in the written agreement, [paragraph (1)](#b-1) shall not apply with respect to such information for a period of more than 36 months.
  - (3) **Disclosures not affected—** Nothing 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 law—** For purposes of [section 552 of title 5](/usc/5/552.md), this subsection shall be considered a statute described in [subsection (b)(3)(B)](/usc/5/552.md?p=b-3-B) of such section 552.
- (c) **Authority to enter into memoranda of understanding for purposes of information exchange—** The [Secretary](/usc/21/321.md?p=d) may enter into written agreements to provide information referenced in [section 331(j) of this title](/usc/21/331.md?p=j) to foreign governments subject to the following criteria:
  - (1) **Certification—** The [Secretary](/usc/21/321.md?p=d) may enter into a written agreement to provide information under this subsection to a foreign government only if the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1).
  - (2) **Written agreement—** The 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](/usc/21/360fff.md?p=8) gives written permission for disclosure or the [Secretary](/usc/21/321.md?p=d) makes a declaration of a public health emergency pursuant to [section 247d of title 42](/usc/42/247d.md) that is relevant to the information.
  - (3) **Information exchange—** The [Secretary](/usc/21/321.md?p=d) may provide to a foreign government that has been certified under [paragraph (1)](#c-1) and that has executed a written agreement under [paragraph (2)](#c-2) information referenced in [section 331(j) of this title](/usc/21/331.md?p=j) in only the following circumstances:
    - (A) Information concerning the inspection of a [facility](/usc/21/364.md?p=3-A) may be provided to a foreign government if—
      - (i) the [Secretary](/usc/21/321.md?p=d) reasonably believes, or the written agreement described in [paragraph (2)](#c-2) establishes, that the government has authority to otherwise obtain such information; and
      - (ii) the written agreement executed under [paragraph (2)](#c-2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes.
    - (B) Information not described in [subparagraph (A)](#c-3-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](/usc/21/321.md?p=d) has reasonable grounds to believe that a [drug](/usc/21/321.md?p=g-1) has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
  - (4) **Effect of subsection—** Nothing in this subsection affects the ability of the [Secretary](/usc/21/321.md?p=d) to enter into any written agreement [authorized](/usc/21/360eee.md?p=2) by other provisions of law to share confidential information.

## Source credit

(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.)

## Notes

### Editorial Notes

### Amendments

2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).