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All Good Things Must Come to an End: FDA Announces End to Enforcement Discretion for Alcohol-Based Hand Sanitizers

As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce alcohol-based hand sanitizers and alcohol for use in such hand sanitizers.
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This week, FDA announced its intent to withdraw these guidances, effective December 31, 2021.

Dude, Where’s My Hand Sanitizer?

In March 2020, FDA issued three guidance documents regarding the manufacture of alcohol-based hand sanitizers. As explained by the Agency, these guidances were intended to provide regulatory flexibility to help meet the demand for alcohol-based hand sanitizers during the COVID-19 public health emergency.

Collectively, these guidances outlined FDA’s temporary policies allowing for:

  1. The preparation of certain alcohol-based hand sanitizer products by companies that register their establishment with FDA as a nonprescription over-the-counter (OTC) drug manufacturer, re-packager, or re-labeler. (Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID‑19));
  2. The compounding of certain alcohol-based hand sanitizer products by pharmacists in State- or territory-licensed pharmacies or Federal facilities and registered outsourcing facilities. (Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency); and
  3. The manufacture of alcohol (i.e., ethanol or ethyl alcohol) for use as the active pharmaceutical ingredient in alcohol-based hand sanitizers. (Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)).

FDA Withdrawal of Temporary Policies

On October 12, 2021, FDA announced its intent to withdraw these three guidances. In explaining this decision, the Agency noted that most consumers and healthcare personnel no longer have difficulty obtaining alcohol-based hand sanitizers and that traditional hand sanitizer manufacturers have indicated that they are able to meet market demand. The Agency’s announcement was followed by a Federal Register Notice issued the next day.

Now What?

Companies manufacturing alcohol-based hand sanitizers and alcohol for use in such hand sanitizers under the three temporary policies noted above must cease production of these products by December 31, 2021.

Companies may distribute any remaining hand sanitizer products that were prepared under these policies (prior to December 31) until March 31, 2022. After that date, the FDA states that it intends to cease its temporary enforcement discretion policies.

Per the Agency, manufacturers that wish to continue producing hand sanitizer after December 31, 2021 may do so provided they comply with the tentative final monograph (TFM) for OTC topical antiseptics and other applicable requirements, including current good manufacturing practice (CGMP) requirements. We note that FDA specifically refers to the need for topical antiseptic products to be “marketed in conformity with the 1994 TFM for OTC topical antiseptics (59 FR 31402, June 17, 1994) as further amended by the 2016 Consumer Antiseptic Rub proposed rule (81 FR 42912, June 30, 2016) and the 2015 Health Care Antiseptics proposed rule (80 FR 25166, May 1, 2015).” (emphasis added).

Although many companies have already been marketing their alcohol-based hand sanitizers under this TFM, it is rather complex and FDA can be expected to more closely scrutinize these products for compliance going forward. 

Therein lies the rub; no pun intended.

Those manufacturers who no longer wish to produce such products can find instructions on how to de-register and de-list their products here.

If you have any questions or are interested in more information about this topic, please contact Arent Fox’s FDA practice.

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