21 U.S.C. § 384e

Current through P.L. 118-106 (published on www.congress.gov on 10/04/2024)

Section 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).

21 U.S.C. § 384e

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

AMENDMENTS2022-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".