APR January/February 2022 - 80

VENDOR VIEWPOINT
FDA Withdrawal of Temporary
COVID-19 Pandemic Hand
Sanitizer Manufacturing
Guidelines; Additional Testing
May Be Required
Russell Griggs, MS
CCRC
Margaret Butler, PhD
BioScience Laboratories, a Nelson Labs company
Background
All hand sanitizers, whether used by consumers or healthcare professionals, are considered
over-the-counter (OTC) drugs that are regulated by the FDA. The most common type of hand
sanitizer has historically been alcohol-based, often called alcohol-based hand rubs (ABHRs).
Prior to the COVID-19 pandemic, hand sanitizers were exclusively produced by companies that
met FDA requirements for drug manufacturers [e.g., those who already complied with Good
Manufacturing Practices (GMP)] and that had submitted safety and efficacy data required to
market these products. However, at the onset of the COVID-19 public health emergency these
traditional suppliers could not increase their supply rapidly enough to meet the high demand
for hand sanitizers that was driven by a CDC recommendation that ABHRs be used to reduce
the spread of COVID-19 when soap and water were not available.
In order to meet the increased demand for ABHRs, the FDA produced three temporary
policies to add regulatory flexibility to allow entities that were not recognized as meeting FDA
requirements for drug manufacturing (e.g., distilleries) to begin to manufacture ethanol and/
or prepare final ABHR formulations. These policies, initially issued in March 2020, included (1)
guidance on how to manufacture acceptable alcohol (ethanol only) to be used in ABHRs,1
(2) guidance on how to prepare a pre-approved mixture of ingredients (alcohol, glycerin,
hydrogen peroxide, water, and denaturant) to produce a standardized ABHR formulation,2
and
(3) guidance for the temporary compounding of the above standardized ABHR formulation
by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing
facilities.3
These policies applied solely to ABHRs and did not include other hand- or skinhygiene
products.
FDA's Withdrawal of Temporary Policies and Deadlines
On October 12, 2021 the FDA's Center for Drug Evaluation and Research (CDER) released a
notification stating that on December 31st, 2021, it intends to withdraw the three guidance
documents regarding temporary policies for production/preparation of ABHRs due to the
observation that supply of hand sanitizers by traditional drug manufacturers now meets
demand. In order to provide time for manufacturers to respond to the removal of these
temporary policies, companies had to halt manufacturing by no later than December 31, 2021,
but will have until March 31, 2022 to completely halt distribution and sale of affected ABHRs. If a
company does not intend to manufacture ABHRs past the December 31st deadline, they are expected
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American Pharmaceutical Review | January/February 2022

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

APR January/February 2022 - Cover1
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