II 

117TH CONGRESS 

2D SESSION S. 3509 

To strengthen the authority of the Food and Drug Administration with 

respect to foreign drug facility inspections. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 13 (legislative day, JANUARY 10), 2022 

Mr. BRAUN (for himself and Ms. ERNST) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To strengthen the authority of the Food and Drug Administration with respect to foreign drug facility inspections. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Creating Efficiency 

5 in Foreign Facility Inspections Act’’. 

6 SEC. 2. STRENGTHENING FOREIGN DRUG FACILITY IN7 SPECTIONS. 

8 Section 704 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 374) is amended by adding at the end the 

10 following: 


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•S 3509 IS

1 ‘‘(i)(1) When the Secretary, and officers or employees 

2 duly designated by the Secretary, conduct inspections 

3 under this section of establishments engaged in the manu4 facturing, processing, packing, or holding of drugs that 

5 are located outside of the United States, the Secretary 

6 shall not notify the owner or operator of such establish7 ment of the planned inspection before the inspection oc8 curs unless— 

9 ‘‘(A) notification to the establishment owner or 

10 operator in advance of an inspection is mandated 

11 under the laws of the country where the establish12 ment is located, in which case, the Secretary shall 

13 provide not more than the minimum advanced notice 

14 so mandated; or 

15 ‘‘(B) the Secretary determines that notification 

16 to the establishment owner or operator in advance of 

17 an inspection is needed to protect the public health. 

18 ‘‘(2)(A) With respect to all inspections described in 

19 paragraph (1), the Secretary shall attempt to minimize the 

20 time between advance notification to an establishment 

21 owner or operator and the conduct of a surveillance in22 spection. 

23 ‘‘(B) If the Secretary determines that notification to 

24 an owner or operator of a foreign establishment of an in25 spection in advance of a surveillance inspection pursuant 


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1 to paragraph (1)(B) is needed, the Secretary shall provide 

2 such notification only as far in advance as is needed to 

3 protect the public health. 

4 ‘‘(3) If an establishment is located in a country that, 

5 on or after the date of enactment of this subsection, enacts 

6 a law that prevents the Secretary from carrying out in7 spections as described in this subsection, the manufacturer 

8 shall agree to waive any right to enforce any advanced9 notice requirement pursuant to such a law, to the extent 

10 expressly permitted under applicable local law. If the man11 ufacturer does not agree to such a waiver, the manufac12 turer shall be deemed to have refused to permit entry or 

13 inspection in violation of section 301(f). 

14 ‘‘(4) The requirement of paragraph (1) shall not 

15 apply to preapproval, prelicensure, or for-cause inspec16 tions.’’. 

Æ 


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