Hand Sanitizer Guidance Extension Act of 2020

Bill: 116-s-3938
Sponsor: full_name: Sen. Thune, John [R-SD]
Introduced: 2020-06-11
Policy area: Health
Subjects: Cardiovascular and respiratory health

Drug safety, medical device, and laboratory regulation

Emergency medical services and trauma care

Hazardous wastes and toxic substances

Health promotion and preventive care

Health technology, devices, supplies

Infectious and parasitic diseases

Manufacturing

Motor fuels
Latest action: action_date: 2020-06-11
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2934-2935; text: CR S2934)

Summaries:
action_date: 2020-06-11
action_desc: Introduced in Senate
text: <p><b>Hand Sanitizer Guidance Extension Act of 2020</b></p> <p class="MsoNormal" style="line-height: normal;">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.</p> <p class="MsoNormal" style="line-height: normal;">The bill also imposes various requirements related to the content of hand sanitizers manufactured while the guidance is in effect.</p>

tv_txt: II 116th CONGRESS 2d Session S. 3938 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. Short title This Act may be cited as the Hand Sanitizer Guidance Extension Act of 2020 . 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.