[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10977-10979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03548]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2016]


Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for 
Methanol, Including During the Public Health Emergency (COVID-19); 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Policy for 
Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, 
Including During the Public Health Emergency (COVID-19).'' This 
guidance is intended to alert pharmaceutical manufacturers and 
pharmacists in State-licensed pharmacies or Federal facilities who 
engage in drug compounding to the potential public health hazard of 
alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated 
with or substituted with methanol. FDA is aware of reports of fatal 
methanol poisoning of consumers who ingested alcohol-based hand 
sanitizers that were manufactured with methanol or methanol-
contaminated ethanol and is concerned that other drug products 
containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which 
are widely used active ingredients in a variety of drug products, could 
be similarly vulnerable to methanol contamination. As the COVID-19 
pandemic has increased the demand for hand sanitizer products, the 
demand for pharmaceutical alcohol as the active ingredient of those 
products has also increased. The guidance outlines a policy intended to 
help pharmaceutical manufacturers and pharmacists in State-licensed 
pharmacies or Federal facilities who engage in drug compounding avoid 
the use of pharmaceutical alcohol that is contaminated with or 
substituted with methanol in drug products. Given the public health 
emergency presented by coronavirus disease 2019 (COVID-19), this 
guidance document is being implemented without prior public comment 
because FDA has determined that prior public participation is not 
feasible or appropriate, but it remains subject to comment in 
accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on February 23, 2021. The guidance document is immediately in 
effect, but it remains subject to comment in accordance with the 
Agency's good guidance practices.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-D-2016 for ``Policy for Testing of Alcohol (Ethanol) and 
Isopropyl Alcohol for Methanol, Including During the Public Health 
Emergency (COVID-19).'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on

[[Page 10978]]

https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Francis Godwin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4342, Silver Spring, MD 20993-0002, 301-
796-5362; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Julie 
Bailey, Center for Veterinary Medicine (HFV-140), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0700.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Policy for Testing of Alcohol (Ethanol) and Isopropyl 
Alcohol for Methanol, Including During the Public Health Emergency 
(COVID-19).'' This guidance is intended to alert pharmaceutical 
manufacturers \1\ and pharmacists in State-licensed pharmacies or 
Federal facilities who engage in compounding to the potential public 
health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl 
alcohol (collectively ``pharmaceutical alcohol'' \2\) contaminated with 
or substituted with methanol. FDA is aware of reports of fatal methanol 
poisoning of consumers who ingested alcohol-based hand sanitizers that 
were manufactured with methanol or methanol-contaminated ethanol and is 
concerned that other drug products containing pharmaceutical alcohol, 
which are widely used active ingredients in a variety of drug products, 
could be similarly vulnerable to methanol contamination. As the COVID-
19 pandemic has increased the demand for hand sanitizer products, the 
demand for pharmaceutical alcohol as the active ingredient of those 
products has also increased.
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    \1\ References to ``manufacturers'' includes registered 
outsourcing facilities, repackers, relabellers, and suppliers of 
alcohol.
    \2\ For the purposes of this guidance, we use the term 
pharmaceutical alcohol to mean either ethanol (ethyl alcohol) or 
isopropyl alcohol (2-propanol). Both are used as an active 
ingredient in alcohol-based hand sanitizers and may be used in other 
drug products as an active or inactive ingredient.
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    The guidance outlines a policy intended to help pharmaceutical 
manufacturers and pharmacists in State-licensed pharmacies or Federal 
facilities who engage in compounding avoid the use of pharmaceutical 
alcohol that is contaminated with or substituted with methanol in drug 
products. The policy outlined in the guidance includes, but is not 
limited to: (1) Performing a specific identity test that includes a 
limit test for methanol on each container within each shipment of each 
lot of pharmaceutical alcohol before the component is used in the 
manufacture or preparation of drug products; (2) knowing the entities 
in pharmaceutical manufacturers' supply chain for pharmaceutical 
alcohol (i.e., knowing the identities and appropriately qualifying the 
manufacturer of the pharmaceutical alcohol and any subsequent 
distributor(s)); (3) ensuring that all personnel in pharmaceutical 
manufacturing facilities (especially personnel directly responsible for 
receipt, testing, and release of pharmaceutical alcohol) are made aware 
of the importance of proper testing and the potential hazards if the 
testing is not done; and (4) establishing finished product test methods 
to ensure that when testing for ethanol or isopropyl alcohol content 
(assay), the method also distinguishes between the active ingredient 
and methanol. The policy outlined in this guidance applies to 
pharmaceutical alcohols used as an active or inactive ingredient in a 
drug.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of the Department of Health and Human 
Services (HHS), FDA has determined that prior public participation for 
this guidance is not feasible or appropriate and is issuing this 
guidance without prior public comment (see section 701(h)(1)(C)(i) of 
the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This 
guidance document is being implemented immediately, but it remains 
subject to comment in accordance with the Agency's good guidance 
practices. FDA will review comments, and the guidance will be updated 
accordingly.
    This guidance is intended to remain in effect for the duration of 
the public health emergency related to COVID-19 declared by HHS, 
including any renewals made by the Secretary in accordance with section 
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). 
However, the recommendations and processes described in the guidance 
are expected to assist the Agency more broadly in its efforts to ensure 
that pharmaceutical alcohol that is contaminated with or substituted 
with methanol is not used in drug products beyond the termination of 
the COVID-19 public health emergency and reflect the Agency's current 
thinking on this issue. Therefore, within 60 days following the 
termination of the public health emergency, FDA intends to revise and 
replace this guidance with any appropriate changes based on comments 
received on this guidance and the Agency's experience with 
implementation.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Policy for Testing of Alcohol (Ethanol) 
and Isopropyl Alcohol for Methanol, Including During the Public Health 
Emergency (COVID-19).'' It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

[[Page 10979]]

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001; the collections of information in 21 CFR part 312 
have been approved under OMB control number 0910-0014; the collections 
of information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338; and the collections of information in 21 CFR parts 
210 and 211 have been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03548 Filed 2-22-21; 8:45 am]
BILLING CODE 4164-01-P