2015 US Code
Title 21 - Food and Drugs (Sections 1 - 2252)
Chapter 9 - Federal Food, Drug, and Cosmetic Act (Sections 301 - 399f)
Subchapter VIII - Imports and Exports (Sections 381 - 384e)
Sec. 384e - Recognition of foreign government inspections
Publication Title | United States Code, 2012 Edition, Supplement 3, Title 21 - FOOD AND DRUGS |
Category | Bills and Statutes |
Collection | United States Code |
SuDoc Class Number | Y 1.2/5: |
Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER VIII - IMPORTS AND EXPORTS Sec. 384e - Recognition of foreign government inspections |
Contains | section 384e |
Date | 2015 |
Laws In Effect As Of Date | January 3, 2016 |
Positive Law | No |
Disposition | standard |
Source Credit | June 25, 1938, ch. 675, §809, as added Pub. L. 112-144, title VII, §712, July 9, 2012, 126 Stat. 1072. |
Statutes at Large Reference | 126 Stat. 1072 |
Public and Private Law | Public Law 112-144 |
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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 inspectionThe 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.)
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