21 U.S. Code § 384e - Recognition of foreign government inspections

(a) InspectionThe 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 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 inspectionThe results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—
(1)
(2)
for any other purposes as determined appropriate by the Secretary.
Editorial Notes
Amendments

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”.