[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56960-56963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1106]


Alcohol-Based Hand Sanitizer Products; Withdrawal of Three 
Temporary Guidance Documents Issued During the Public Health Emergency 
of the Coronavirus Disease 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the withdrawal of three guidance documents entitled

[[Page 56961]]

``Temporary Policy for Preparation of Certain Alcohol-Based Hand 
Sanitizer Products During the Public Health Emergency (COVID-19),'' 
``Policy for Temporary Compounding of Certain Alcohol-Based Hand 
Sanitizer Products During the Public Health Emergency,'' and 
``Temporary Policy for Manufacture of Alcohol for Incorporation Into 
Alcohol-Based Hand Sanitizer Products During the Public Health 
Emergency (COVID-19),'' which were issued in March 2020 (and updated 
March 27, 2020, April 15, 2020, June 1, 2020, August 7, 2020, and 
February 10, 2021). FDA is withdrawing these three guidance documents 
because current data indicate that consumers and healthcare personnel 
are no longer experiencing difficulties accessing alcohol-based hand 
sanitizer products, and these temporary policies are no longer needed 
to help meet demand for alcohol-based hand sanitizer products or for 
alcohol for use in alcohol-based hand sanitizer.

DATES: The withdrawal date for the three guidances is December 31, 
2021. Firms manufacturing alcohol under the temporary policies for use 
in alcohol-based hand sanitizers and firms preparing alcohol-based hand 
sanitizers under the temporary policies must cease production of these 
products by December 31, 2021. Firms must cease, by March 31, 2022, 
distribution of any remaining hand sanitizer products that were 
prepared under the temporary policies before or on December 31, 2021. 
After March 31, 2022, FDA intends to cease its temporary policy of not 
taking action with regard to distribution of hand sanitizers, or 
alcohol for use in alcohol-based hand sanitizers, prepared consistent 
with the circumstances described in the guidance documents.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support 
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in March 2020, the Agency published three guidance 
documents to provide regulatory flexibility to certain firms to help 
meet the demand for alcohol-based hand sanitizer during the COVID-19 
public health emergency (PHE).\2\ The guidance documents communicate 
the Agency's temporary policies on the manufacture of alcohol for use 
in alcohol-based hand sanitizers, or alcohol-based hand sanitizers for 
consumer use and for use as healthcare personnel hand rubs \3\ for the 
duration of the PHE declared by the Secretary of Health and Human 
Services on January 31, 2020, and subsequently renewed. The following 
is a brief description of each guidance:
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    \1\ The virus has been named ``SARS-CoV-2'' and the disease it 
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
    \2\ For example, as explained in the guidance entitled 
``Temporary Policy for Preparation of Certain Alcohol-Based Hand 
Sanitizer Products During the Public Health Emergency (COVID-19),'' 
provided that circumstances described in the guidance are present, 
FDA does not intend to take action against firms, for the duration 
of the public health emergency, for violations of sections 319(a)(2) 
of the Public Health Service Act (42 U.S.C. 247d(a)(2)) or sections 
501(a)(2)(B), 502(f)(1), 505, or 582 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B), 352(f)(1), 355, and 
360eee-1), which include certain aspects of current good 
manufacturing practice, certain labeling requirements, new drug 
application requirements, and pharmaceutical distribution supply 
chain requirements.
    \3\ FDA uses the term ``hand sanitizer'' throughout this Notice 
of Withdrawal, and the referenced guidance documents, to refer to 
OTC topical antiseptic rubs for use by consumers, as well as those 
for use by healthcare personnel in hospital and healthcare settings.
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     The first guidance,\4\ ``Temporary Policy for Preparation 
of Certain Alcohol-Based Hand Sanitizer Products During the Public 
Health Emergency (COVID-19),'' communicates FDA's policy for the 
temporary preparation of certain alcohol-based hand sanitizer products 
by firms that register their establishment with FDA as a 
nonprescription over-the-counter (OTC) drug manufacturer, re-packager, 
or re-labeler, under the circumstances described in the guidance.
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    \4\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during.
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     The second guidance,\5\ ``Policy for Temporary Compounding 
of Certain Alcohol-Based Hand Sanitizer Products During the Public 
Health Emergency,'' communicates FDA's policy for the temporary 
compounding of certain alcohol-based hand sanitizer products by 
pharmacists in State- or territory-licensed pharmacies or Federal 
facilities and registered outsourcing facilities, under the 
circumstances described in the guidance.
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    \5\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health.
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     The third guidance,\6\ ``Temporary Policy for Manufacture 
of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products 
During the Public Health Emergency (COVID-19),'' communicates FDA's 
policy for the temporary manufacture of alcohol (i.e., ethanol or ethyl 
alcohol) by firms for use as the active pharmaceutical ingredient in 
alcohol-based hand sanitizers under the circumstances described in the 
guidance.
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    \6\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during.
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    We appreciate industry's willingness to help supply hand sanitizer 
to the market in response to the COVID-19 PHE.
    As explained in these guidance documents, FDA has continually 
assessed the needs and circumstances related to these temporary 
policies, and as relevant needs and circumstances evolved, FDA made 
updates and modifications to these temporary policies. The guidance 
documents also state that this assessment includes withdrawing these 
temporary policies as appropriate.
    Based on our review of currently available data, we have determined 
that the needs and circumstances related to these temporary policies 
have evolved such that the temporary policies are no longer needed and 
the three guidance documents should be withdrawn.\7\ As explained in 
this document, this determination is based on current data that show 
that demand for alcohol-based hand sanitizer has decreased and the 
supply of hand sanitizer from traditional manufacturers (i.e., firms 
other than those that entered into the OTC drug industry for the first 
time in order to supply hand sanitizers during the COVID-19 PHE) has 
increased. Most consumers and healthcare personnel are no longer 
experiencing difficulties accessing alcohol-based hand sanitizer 
products.
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    \7\ We note that withdrawal of these guidance documents will not 
cause an assessment of fees on manufacturers of OTC hand sanitizers 
under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). 
OMUFA fees are distinct from these guidance documents and are 
addressed in FDA's Federal Register notice of March 26, 2021 (86 FR 
16223), entitled ``Fee Rates Under the Over-the-Counter Monograph 
Drug User Fee Program for Fiscal Year 2021.'' As this Federal 
Register notice explains, ``FDA will not assess OMUFA facility fees 
upon those firms that first registered with FDA on or after the 
January 27, 2020 declaration of the COVID-19 Public Health Emergency 
(PHE), solely for purposes of manufacturing hand sanitizer products 
during the PHE'' (86 FR 16223 at 16225). Additional information is 
available in this FDA Federal Register notice and the Health and 
Human Services Federal Register notice of January 12, 2021 (86 FR 
2420).
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    During the course of the COVID-19 PHE, FDA has conducted several 
surveys of hospital systems to monitor

[[Page 56962]]

the supply and sources of alcohol-based hand sanitizer products. Based 
on the results of these surveys, current data show that the hand 
sanitizer supply disruption in hospitals has decreased significantly 
and that hand sanitizer from traditional manufacturers now comprise the 
majority of these hospital systems' supply. Specifically, all the 
hospital systems that responded to FDA's July 2021 survey on hand 
sanitizer supply stated that they are not experiencing a current 
disruption in their supply of hand sanitizer, and only 9 percent of 
these hospital systems anticipated a future disruption in supply. In 
addition, 94 percent of the hospital systems responding to the July 
2021 survey reported that the majority of their current hand sanitizer 
product is produced by traditional manufacturers. Recent reports also 
indicate that there is now a surplus of hand sanitizer products on 
retail shelves.\8\ Moreover, certain traditional hand sanitizer 
manufacturers indicate that they are able to meet demand and fully 
supply the marketplace with hand sanitizer products.\9\ A large 
manufacturer of hand sanitizer products has expanded production 
capacity and is producing and shipping 300 percent more hand sanitizer 
product than in 2019.\10\
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    \8\ See, e.g., the newspaper articles at https://www.wsj.com/articles/america-is-awash-in-hand-sanitizer-11621522829; https://www.washingtonpost.com/local/last-year-hand-sanitizer-was-a-precious-commodity-now-theyre-giving-it-away/2021/06/24/351f1278-d504-11eb-9f29-e9e6c9e843c6_story.html; https://www.usatoday.com/story/money/2021/04/08/hand-sanitizer-deals-donations-surplus-panic-buying-pandemic/7120815002/ (Refs. 1, 2, and 3).
    \9\ See April 28, 2021, letter from the American Cleaning 
Institute/Consumer Healthcare Products Association to FDA, available 
at https://www.regulations.gov/comment/FDA-2020-D-1106-0164 (Ref. 4) 
(stating that their members ``have the capacity to fully supply the 
marketplace'' and have ``increased production of cGMP-compliant 
products to meet the demand for both consumer and healthcare 
markets,'' at 3).
    \10\ See https://www.gojo.com/en/Newsroom/Press-Releases/2021/PURELL-Brand-Strongly-Positioned-to-Support-Safe-Reopening-of-Schools (Ref. 5).
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    FDA published its temporary policies for alcohol-based hand 
sanitizers in response to the increase in demand for alcohol-based hand 
sanitizer products during the COVID-19 PHE and with the understanding 
that some consumers and healthcare personnel were experiencing 
difficulties accessing alcohol-based hand sanitizer products. Although 
the PHE is still ongoing \11\ and there currently is an increase in 
COVID-19 cases, the data indicate that: (1) Supply from traditional 
manufacturers has increased; (2) the demand for alcohol-based hand 
sanitizer that existed earlier in the pandemic has significantly 
decreased; and (3) most consumers and healthcare personnel are no 
longer having difficulty accessing alcohol-based hand sanitizer 
products. Additionally, since declaration of the COVID-19 PHE,\12\ some 
hand sanitizer products made by firms that entered the market during 
the COVID-19 PHE have been recalled, placed on import alert, and/or 
been the subject of compliance actions due to quality and other issues. 
Accordingly, the needs and circumstances related to these temporary 
policies have evolved such that the temporary policies are no longer 
warranted and the guidance documents should be withdrawn.
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    \11\ Secretary of Health and Human Services,'' Determination 
that a Public Health Emergency Exists Nationwide as the Result of 
the 2019 Novel Coronavirus'' (originally issued January 31, 2020, 
and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx (Ref. 6).
    \12\ The HHS Declaration of a Public Health Emergency is 
available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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    We note that the recently enacted Coronavirus Aid, Relief, and 
Economic Security Act (Pub. L. 116-136) added section 505G to the FD&C 
Act (21 U.S.C. 355g). Under section 505G(a)(3) of the FD&C Act, drugs 
that were classified as category III \13\ in a tentative final 
monograph (TFM) that is the most recently applicable proposal or 
determination for such drugs issued under 21 CFR part 330--and that 
were not classified in such a TFM as category II for safety or 
effectiveness--are not required to have an approved application under 
section 505 to be marketed, as long as they are in conformity with the 
relevant conditions of use outlined in the applicable TFM and comply 
with all other applicable requirements. This includes topical 
antiseptic products 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), as long as they also comply with other applicable 
requirements.
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    \13\ Under the OTC Drug Review, FDA classified drugs as category 
III where FDA determined that the available data are insufficient to 
classify the drug as generally recognized as safe and effective, and 
further testing is required (see 21 CFR 330.10(a)(5)(iii) and 
(a)(6)(iii)).
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    Accordingly, although the temporary policies are being withdrawn as 
described above, firms may continue to manufacture alcohol-based hand 
sanitizer products without an approved application, provided they 
comply with the applicable TFM and other applicable requirements, 
including current good manufacturing practice (CGMP) requirements under 
section 501(a)(2)(B) of the FD&C Act. Under CGMP, among other things, 
drug product manufacturers are required \14\ to test their drug 
products prior to release to assure that the drug products meet the 
requirements for safety and have the identity and strength, and meet 
the quality and purity characteristics, that the drug products purport 
to possess. We remind distributors, re-packagers, and importers that 
they are also responsible for the safety and quality of the drugs they 
introduce into interstate commerce.
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    \14\ See 21 CFR 211.165 Testing and release for distribution.
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    Firms preparing alcohol-based hand sanitizer products under FDA's 
temporary policies (other than compounding pharmacies) had to register 
their facility and list these products in the FDA Drug Registration and 
Listing System (DRLS, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls).\15\ We remind firms that registered and submitted drug product 
listing(s) for hand sanitizer(s) only but no longer manufacture such 
product, or plan to cease manufacturing such product, to deregister and 
delist their hand sanitizer product listing(s) by following the 
instructions on the Electronic Drug Registration and Listing 
Instructions page (https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions).
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    \15\ Every person required to register with FDA must, at the 
time of initial registration, list all drugs manufactured, prepared, 
propagated, compounded, or processed for commercial distribution. 
See section 510(j)(1) of the FD&C Act (21 U.S.C. 360(j)(1)); see 
also 21 CFR 207.17 and 207.41. Firms that are required to register 
their foreign establishment with FDA must list all known importers 
in the United States in their registration in accordance with 
section 510(i)(1)(A) of the FD&C Act. See also 21 CFR 207.25(h)(2).
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    To deregister an establishment using CDER Direct:
     Log into your account and open the previously accepted 
version of the registration submission.
     Click on CREATE NEW VERSION. This will create a copy of 
the file, keeping the same SetID, but generate a new RootID, Version 
Number, and Effective Date.
     For Document type, Select ESTABLISHMENT DE-REGISTRATION 
from the drop-down list.
     Click SUBMIT SPL.

[[Page 56963]]

    To deregister an establishment from other software applications:
     Create an establishment deregistration SPL document.
     Fill in the SetID with the SetID from your previously 
accepted version.
     Enter the appropriate effective date and version number 
(generally, one number higher than the previous submission).
     Submit.
    To delist a product using CDER Direct:
     Log into your account and open the previously accepted 
version of drug listing submission.
     Click on CREATE NEW VERSION. This will create a copy of 
the file, keeping the same SetID, but generate a new RootID, Version 
Number, and Effective date.
     Click on the product to edit the Product Data Elements. 
Change the Marketing Status from ``ACTIVE'' to ``COMPLETED'' and enter 
a Marketing End Date no later than March 31, 2022.
     Save changes and click SUBMIT SPL.
    To delist a product from other software applications:
     Open the previously accepted version of drug listing 
submission.
     Create a new version with the same SetID from your 
previous submission, but generate a new RootID.
     Enter the appropriate effective date and version number 
(generally, one number higher than the previous submission).
     Edit the product data elements. Change the Marketing 
Status from ``ACTIVE'' to ``COMPLETED'' and enter a Marketing End Date 
no later than March 31, 2022.
     Save and Submit.
    To request additional assistance with deregistration and delisting, 
please contact [email protected].

II. Withdrawal Date

    The withdrawal date for the three guidance documents discussed in 
this document is December 31, 2021. Accordingly, firms manufacturing 
alcohol under the temporary policies for use in alcohol-based hand 
sanitizers and firms and compounders preparing alcohol-based hand 
sanitizers under the temporary policies must cease production of these 
products by December 31, 2021. In addition, firms must by March 31, 
2022, cease distribution of any remaining hand sanitizer products that 
were prepared under the temporary policies before or on December 31, 
2021. After March 31, 2022, FDA intends to cease its temporary policy 
of not taking action with regard to distribution of hand sanitizers or 
alcohol for use in alcohol-based hand sanitizers prepared consistent 
with the circumstances described in the withdrawn guidance documents. 
The COVID-19 pandemic is a constantly evolving situation. FDA continues 
to assess these circumstances and should the current data change to 
indicate that hand sanitizer demand has again outstripped supply prior 
to December 31, 2021, FDA may alter these dates. However, firms should 
assume these dates will not change and prepare accordingly for 
cessation of manufacture and distribution of these products.

III. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, and are available for viewing by interested persons between 9 
a.m. and 4 p.m., Monday through Friday; they are also available 
electronically at http://www.regulations.gov. References in the Notice 
without asterisks are not available electronically at https://www.regulations.gov because they have copyright restrictions, but they 
are on display at the Dockets Management Staff and available for 
viewing at the location and times noted above. Some may be available at 
the website address, if any, listed with the reference or such website 
may provide further information on obtaining copies. FDA has verified 
the website addresses, as of the date this document publishes in the 
Federal Register, but websites are subject to change over time.

1. Kang, J., ``Retailers Couldn't Stock Hand Sanitizer Fast Enough. 
Now They Can't Give It Away,'' The Wall Street Journal, May 20, 
2021, (available at https://www.wsj.com/articles/america-is-awash-in-hand-sanitizer-11621522829), accessed August 30, 2021.
2. Dvorak, P., ``Last Year, Hand Sanitizer Was a Precious Commodity. 
Now They're Giving It Away,'' The Washington Post, June 24, 2021 
(available at https://www.washingtonpost.com/local/last-year-hand-sanitizer-was-a-precious-commodity-now-theyre-giving-it-away/2021/06/24/351f1278-d504-11eb-9f29-e9e6c9e843c6_story.html), accessed 
August 30, 2021.
3. Bomey, N., ``Panic Buying? Not Anymore. Suddenly There's a 
Surplus of Hand Sanitizer,'' USA Today, April 8, 2021 (available at 
https://www.usatoday.com/story/money/2021/04/08/hand-sanitizer-deals-donations-surplus-panic-buying-pandemic/7120815002/), accessed 
August 30, 2021.
4. *Letter from James Kim and Barbara Kochanowski, ACI/CHPA, to 
Theresa Michele, FDA, April 28, 2021 (available at https://www.regulations.gov/comment/FDA-2020-D-1106-0164), accessed August 
30, 2021.
5. Gojo, ``PURELL Brand Strongly Positioned to Support Safe 
Reopening of Schools,'' February 22, 2021 (available at https://www.gojo.com/en/Newsroom/Press-Releases/2021/PURELL-Brand-Strongly-Positioned-to-Support-Safe-Reopening-of-Schools), accessed August 
30, 2021.
6. *Secretary of the Department of Health and Human Services, 
``Determination that a Public Health Emergency Exists Nationwide as 
the Result of the 2019 Novel Coronavirus,'' originally issued 
January 31, 2020, and subsequently renewed (available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx), 
accessed August 30, 2021.

    Dated: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22108 Filed 10-12-21; 8:45 am]
BILLING CODE 4164-01-P