§384e — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can make agreements with foreign governments or their agencies to accept inspections of foreign drug facilities that are registered under section 360(i). These agreements are meant to help with preapproval or risk-based inspections that follow the schedule in section 360(h). The Secretary can only make such agreements with governments the Secretary finds can meet the law’s inspection standards. The Secretary must review and audit foreign drug safety programs as needed to be sure they can do inspections that meet those standards. Inspection results from a foreign government may be used as proof of compliance with sections 351(a)(2)(B) or 381(r), and for other uses the Secretary finds appropriate. Starting no later than 1 year after December 29, 2022, the Secretary must periodically check whether more such agreements are appropriate. Starting no later than 4 years after December 29, 2022, and every 4 years after that, the Secretary must send a report of those reviews to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

Title 21, §384e

Food and Drugs — Source: USLM XML via OLRC

(a)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)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)(1)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)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).

Notes & Related Subsidiaries

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”.

§384e Recognition of foreign government inspections

Summary

Title 21, §384e

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata