---
kind: "section"
citation: "21 U.S.C. § 384e"
title: "21"
title_heading: "Food and Drugs"
number: "384e"
heading: "Recognition of foreign government inspections"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/384e"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VIII — Imports and Exports"
---

# §384e. Recognition of foreign government inspections

- (a) **Inspection—** The [Secretary](/usc/21/321.md?p=d)—
  - (1) may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under [section 360(i) of this title](/usc/21/360.md?p=i) in order to facilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of [section 360(h) of this title](/usc/21/360.md?p=h);
  - (2) may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the [Secretary](/usc/21/321.md?p=d) has determined as having the capability of conducting inspections that meet the applicable requirements of this chapter; and
  - (3) shall perform such reviews and audits of [drug](/usc/21/321.md?p=g-1) safety programs, systems, and standards of a foreign government or agency for the foreign government as the [Secretary](/usc/21/321.md?p=d) deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter.
- (b) **Results of inspection—** The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—
  - (1) evidence of compliance with [section 351(a)(2)(B) of this title](/usc/21/351.md) or [section 381(r) of this title](/usc/21/381.md?p=r); and
  - (2) for any other purposes as determined appropriate by the [Secretary](/usc/21/321.md?p=d).
- (c) **Periodic review—**
  - (1) **In general—** Beginning not later than 1 year after December 29, 2022, the [Secretary](/usc/21/321.md?p=d) shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate.
  - (2) **Reports to Congress—** Beginning not later than 4 years after December 29, 2022, and every 4 years thereafter, the [Secretary](/usc/21/321.md?p=d) shall submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under [paragraph (1)](#c-1).

## Source credit

(June 25, 1938, ch. 675, § 809, as added Pub. L. 112–144, title VII, § 712, July 9, 2012, 126 Stat. 1072; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(X), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title VII, § 701(b), Aug. 18, 2017, 131 Stat. 1055; Pub. L. 117–328, div. FF, title III, § 3613(c), Dec. 29, 2022, 136 Stat. 5872.)

## Notes

### Editorial Notes

### Amendments

2022—Subsec. (a)(1). Pub. L. 117–328, § 3613(c)(1), inserted “preapproval or” before “risk-based inspections”.

Subsec. (c). Pub. L. 117–328, § 3613(c)(2), added subsec. (c).

2017—Subsec. (a)(1). Pub. L. 115–52 substituted “paragraph (2) or (3) of section 360(h)” for “section 360(h)(3)”.

2016—Subsec. (a)(2). Pub. L. 114–255 substituted “conducting” for “conduction”.