21 U.S.C. § 384e

section 360(i) of this titlesection 360(h) of this title 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 in order to facilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of ;

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

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.

section 351(a)(2)(B) of this titlesection 381(r) of this title evidence of compliance with or ; and

for any other purposes as determined appropriate by the Secretary.

December 29, 2022Beginning not later than 1 year after , 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.

December 29, 2022Beginning not later than 4 years after , 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).