II 

116TH CONGRESS 

2D SESSION S. 3938 

To extend Federal guidance concerning the use of certain alcohol-based hand 

sanitizer during the coronavirus public health emergency, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 11, 2020 

Mr. THUNE (for himself, Mr. BRAUN, Mr. GRASSLEY, Mr. ROUNDS, 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 extend Federal guidance concerning the use of certain 

alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. 

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 ‘‘Hand Sanitizer Guid5 ance Extension Act of 2020’’. 

6 SEC. 2. FEDERAL GUIDANCE ON HAND SANITIZER. 

7 (a) EXTENSION OF FEDERAL GUIDANCE.—The Food 

8 and Drug Administration guidance entitled ‘‘Guidance for 

9 Industry: Temporary Policy for Preparation of Certain AlVerDate Sep 11 2014 04:35 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3938.IS S3938

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•S 3938 IS

1 cohol-Based Hand Sanitizer Products During the Public 

2 Health Emergency (COVID–19)’’, initially released on 

3 March 23, 2020, and updated on April 15, 2020, and on 

4 June 1, 2020, shall remain in effect until the date that 

5 is 2 years after the date of enactment of this Act. 

6 (b) EFFECT OF EXTENSION.—During the 2-year pe7 riod described in subsection (a), the Food and Drug Ad8 ministration shall permit the production, sale, and use of 

9 hand sanitizer, consistent with the guidance described in 

10 subsection (a), provided that such hand sanitizer is manu11 factured using only the following ingredients in the prepa12 ration of the product: 

13 (1)(A) Subject to subsection (c), alcohol (eth14 anol) that is not less than 94.9 percent ethanol by 

15 volume; or 

16 (B) United States Pharmacopeia grade iso17 propyl alcohol. 

18 (2) United States Pharmacopeia grade or Food 

19 Chemical Codex grade glycerin (glycerol). 

20 (3) Hydrogen peroxide. 

21 (4) Sterile water meeting United States Phar22 macopeia specifications for purified water. 

23 (c) ETHANOL PRODUCED IN CERTAIN FACILITIES.— 

24 Ethanol produced in facilities normally producing fuel or 


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•S 3938 IS

1 technical ethanol may be used as described in subsection 

2 (b)(1)(A) only if such ethanol— 

3 (1) meets United States Pharmacopeia or Food 

4 Chemical Codex grade requirements; 

5 (2) has been screened for any other potentially 

6 harmful impurities not specified in the United States 

7 Pharmacopeia or Food Chemical Codex require8 ments; or 

9 (3) has otherwise been approved for use by the 

10 Food and Drug Administration. 

11 (d) AUTOMATIC EXTENSION.—The effective period of 

12 the guidance described in subsection (a) shall automati13 cally be extended for 1 additional year if the Secretary 

14 of Health and Human Services determines that a public 

15 health emergency exists at the time that the 2-year period 

16 described in subsection (a) expires. 

17 (e) EXEMPTION.—If the Commissioner of Food and 

18 Drugs determines that a public health emergency requires 

19 that the requirement for the use of denatured alcohol be 

20 reduced, or requires a waiver of any other requirement 

21 with respect to hand sanitizer under the guidance, the 

22 Commissioner of Food and Drugs may waive or reduce 

23 such requirement, as applicable. 

Æ 


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