21-U.S.C.-384E

§384E – Recognition of Foreign Government Inspections

Pathway

Title 21 > Chapter 9 > Subchapter VIII > Section 384e

Details

• Reference: Section 384e
• Legend: §384E – Recognition of Foreign Government Inspections
• USCode Year: 2013

Provision Content

(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 risk-based inspections in accordance with the schedule established in section 360(h)(3) 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 conduction 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.

(June 25, 1938, ch. 675, §809, as added Pub. L. 112–144, title VII, §712, July 9, 2012, 126 Stat. 1072.)

U.S. Encyclopedia of Law Coverage

21-U.S.C.-384A in the Legal Encyclopedia: Imports

In this entry about 21-U.S.C.-384A, find legal reference material, bibliographies and premiere content related to imports in the American Encyclopedia of Law, presenting a comprehensive view of the United States imports-specific issues, written by authorities in the field.

21-U.S.C.-959 in the Legal Encyclopedia: Exports

In this entry about 21-U.S.C.-959, find legal reference material, bibliographies and premiere content related to exports in the American Encyclopedia of Law, presenting a comprehensive view of the United States exports-specific issues, written by authorities in the field.

Topic Map

• Browse the Topic Map in relation with Title 21 (Food And Drugs) guided by subject interests.