FDA recently issued two immediately effective guidance documents to help increase the availability of hand sanitizer to the public and health care personnel due to shortages brought about by the COVID-19 pandemic. One of the documents, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), permits entities that are not currently licensed or registered drug manufacturers to prepare alcohol-based hand sanitizers under specified conditions. (The other guidance document not addressed here, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, allows for compounding of certain alcohol-based hand sanitizers by pharmacies, outsourcing facilities and other entities.)

What is the Purpose of the FDA Guidance?

The guidance communicates FDA’s policy to temporarily allow companies that register with FDA as over-the-counter (OTC) drug manufacturers to prepare certain alcohol-based hand sanitizer products for consumer use and as health care personnel hand rubs.

How Long Will the Policy Be in Effect?

The policy will remain in effect only for the duration of the COVID-19 public health emergency declared by the Department of Health and Human Services on January 31, 2020. When the emergency is over, FDA intends to withdraw the guidance and stop the temporary policy.

What FDA Requirements Does an Entity Need to Meet to Manufacture Hand Sanitizer?

The guidance documents sets forth six requirements that manufacturers must meet to prepare hand sanitizers under the temporary policy:

• The products must be made with only the specified United States Pharmacopoeia (USP) grade ingredients consistent with World Health Organization (WHO) recommended formulations, with no additional active or inactive ingredients.
• The manufacturer must implement process controls and steps to make sure the ethanol or isopropyl alcohol active ingredient is correct and the correct amounts are used, and should document these measures.
• Conditions of preparation must be sanitary, and equipment must be maintained and fit for this purpose.
• The manufacturer should perform sample testing of finished drug product to verify the alcohol content before each batch release, using methods specified in the guidance.
• Labeling must be consistent with the examples provided in the guidance.
• The manufacturer must register their facility and list these products in the FDA Drug Registration and Listing System.

What Products Are Not Covered by the Policy?

The policy does not cover surgical hand rubs, products that use different active ingredients or have different potencies than the formulations described, products with false or misleading labeling, or products that are marketed with pathogen-specific or other claims that do not conform to the “Topical Anti-Microbial Drug Products for Over-the-Counter Human Use: Tentative Final Monograph for Health-Care Antiseptic Drug Products” Proposed Rule.

Are There Any Other Requirements for Manufacturers under the Policy?

Yes. In addition to meeting the formulation, labeling, manufacturing, registration and listing requirements set forth above, manufacturers must have a way to receive reports of adverse events related to their products and to submit such reports to FDA.

Is There Any Action by Other Agencies to Help with the Shortage of Hand Sanitizer?

Yes. In connection with the hand sanitizer shortage, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) is providing certain exemptions and authorizations to distilled spirits permittees who want to produce hand sanitizers, including exempting alcohol fuel plants and beverage distilled spirits plants from requiring additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer.