Title: Hand Sanitizer Guidance Extension Act of 2020
Policy area: Health

Summary:
Hand Sanitizer Guidance Extension Act of 2020
This bill specifies that certain Food and Drug Administration guidance related to the manufacture of alcohol-based hand sanitizers during the COVID-19 (i.e., coronavirus disease 2019) public health emergency shall remain in effect for two years after this bill's enactment.
The bill also imposes various requirements related to the content of hand sanitizers manufactured while the guidance is in effect.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3938 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Hand Sanitizer Guidance Extension 
Act of 2020''.

SEC. 2. FEDERAL GUIDANCE ON HAND SANITIZER.

    (a) Extension of Federal Guidance.--The Food and Drug 
Administration guidance entitled ``Guidance for Industry: Temporary 
Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products 
During the Public Health Emergency (COVID-19)'', initially released on 
March 23, 2020, and updated on April 15, 2020, and on June 1, 2020, 
shall remain in effect until the date that is 2 years after the date of 
enactment of this Act.
    (b) Effect of Extension.--During the 2-year period described in 
subsection (a), the Food and Drug Administration shall permit the 
production, sale, and use of hand sanitizer, consistent with the 
guidance described in subsection (a), provided that such hand sanitizer 
is manufactured using only the following ingredients in the preparation 
of the product:
            (1)(A) Subject to subsection (c), alcohol (ethanol) that is 
        not less than 94.9 percent ethanol by volume; or
            (B) United States Pharmacopeia grade isopropyl alcohol.
            (2) United States Pharmacopeia grade or Food Chemical Codex 
        grade glycerin (glycerol).
            (3) Hydrogen peroxide.
            (4) Sterile water meeting United States Pharmacopeia 
        specifications for purified water.
    (c) Ethanol Produced in Certain Facilities.--Ethanol produced in 
facilities normally producing fuel or technical ethanol may be used as 
described in subsection (b)(1)(A) only if such ethanol--
            (1) meets United States Pharmacopeia or Food Chemical Codex 
        grade requirements;
            (2) has been screened for any other potentially harmful 
        impurities not specified in the United States Pharmacopeia or 
        Food Chemical Codex requirements; or
            (3) has otherwise been approved for use by the Food and 
        Drug Administration.
    (d) Automatic Extension.--The effective period of the guidance 
described in subsection (a) shall automatically be extended for 1 
additional year if the Secretary of Health and Human Services 
determines that a public health emergency exists at the time that the 
2-year period described in subsection (a) expires.
    (e) Exemption.--If the Commissioner of Food and Drugs determines 
that a public health emergency requires that the requirement for the 
use of denatured alcohol be reduced, or requires a waiver of any other 
requirement with respect to hand sanitizer under the guidance, the 
Commissioner of Food and Drugs may waive or reduce such requirement, as 
applicable.
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