Us Code § 384e - Recognition of foreign government inspections
Full text of Us Code United States Code § 384e — Recognition of foreign government inspections, with citation guidance and answers to common questions.
§ 384e. Recognition of foreign government inspections
(a) Inspection
The Secretary—
(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 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;
(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 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 safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary 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 or section 381(r) of this title; and
(2) for any other purposes as determined appropriate by the Secretary.
(c) Periodic review
(1) In general
Beginning not later than 1 year after December 29, 2022, the Secretary 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 shall submit to the Committee on Energy and Commerce 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).
(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.)
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".
About This Section
21 U.S.C. § 384e is part of Title 21 of the United States Code. The United States Code is the official codification of federal statutes maintained by the Office of the Law Revision Counsel of the U.S. House of Representatives. Congress amends the Code through new public laws, which are eventually incorporated into the relevant title.
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