Given the outbreak of the novel coronavirus (COVID-19) and the World Health Organization’s declaration of it becoming a pandemic, the United States has recently seen a surge in COVID-19 cases and is facing significant shortages in supplies to protect against the virus.

Hand hygiene is an important part of the U.S. response to COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).

In the United States, hand sanitizer is regulated as an OTC drug under the U.S. Food and Drug Administration (FDA). Under this regulation, there are requirements around the quantity of active (currently only three are approved), its purity (the active must meet the current monograph for that specific ingredient), as well as the purity of the inactives (excipients). As a regulated drug under the FDA, hand sanitizers must also be manufactured under Good Manufacturing Practice (GMP) conditions according to 21 CFR 210 and 211.

Given the difficulties consumers and health care professionals are experiencing to access alcohol-based hand sanitizers, the US FDA has temporarily relaxed some of these requirements to allow other companies to support the need/demand for hand sanitizers. According to the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry released March 20, 2020, the FDA indicated they will not take action against companies who make alcohol-based (ethanol or isopropanol) hand sanitizers during the duration of the public health emergency, AS LONG AS certain criteria are met.

The following circumstances should be adhered to:

• Exact formulation must be followed (see below for formulation requirements);
• USP grade raw materials must be used, or Food Chemical Codex compliant ethanol;
• Ensure controls are in place to ensure 80% alcohol or 75% isopropyl alcohol, and must analyze each batch prior to distribution;
• Ensure the sanitizer is made under sanitary conditions (Facilities must prevent insanitary conditions under section 501(a)(2)(A) of the FD&C Act (21 U.S.C. § 351(a)(2)(A)).);
• Hand Sanitizer label adheres to requirements listed in the guidance;
• Facility must be registered with the FDA in the Drug Registration and Listing System;
• Ensure there is a process to adverse event reports, and any received must be sent to the FDA.

Formulation Requirements
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

Note: Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; isopropyl alcohol should be used in a concentration between 70-91.3% (v/v). This guidance is consistent with the WHO’s recommended formulation specifications of 80% alcohol and 75% isopropyl alcohol.

If you are interested in learning more about this policy and specific compliance requirements, please send an email to enquiry@reach24h.com.

Link to FDA’s press release – https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost

Link to FDA’s temporary policy – https://www.fda.gov/media/136289/download

The FDA also released a second temporary policy for compounding certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.    The temporary policy does not require compounders to obtain patient-specific prescription.  For additional information, please review the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (https://www.fda.gov/media/136118/download)