Notice2023-22843
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry; Availability
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Published
October 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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." 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. During the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), FDA became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol. FDA 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. This guidance replaces the guidance for industry entitled "Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)" published in January 2021.
Full Text
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<title>Federal Register, Volume 88 Issue 199 (Tuesday, October 17, 2023)</title>
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[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Pages 71576-71578]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22843]
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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; 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.'' 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. During the Coronavirus Disease 2019
(COVID-19) public health emergency (PHE), FDA became aware of reports
of fatal methanol poisoning of consumers who ingested alcohol-based
hand sanitizer products that were manufactured with methanol or
methanol-contaminated ethanol. FDA 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. This
guidance replaces the guidance for industry entitled ``Policy for
Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including
During the Public Health Emergency (COVID-19)'' published in January
2021.
DATES: The announcement of the guidance is published in the Federal
Register on October 17, 2023.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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; or to
Policy and Regulations Staff, HFV-6, Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
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 Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,
[[Page 71577]]
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 final guidance for industry
entitled ``Policy for Testing of Alcohol (Ethanol) and Isopropyl
Alcohol for Methanol.'' This guidance is intended to alert
pharmaceutical manufacturers 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'')
contaminated with or substituted with methanol. During the COVID-19
PHE, FDA became aware of reports of fatal methanol poisoning of
consumers who ingested alcohol-based hand sanitizer products that were
manufactured with methanol or methanol-contaminated ethanol. FDA 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.
This 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.
This guidance replaces the guidance entitled ``Policy for Testing
Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During
the Public Health Emergency (COVID-19)'' posted in January 2021 and
announced in the Federal Register on February 23, 2021 (86 FR 10977)
(hereafter ``2021 COVID-19 Methanol Guidance''). FDA issued the
guidance to communicate its policy for the duration of the COVID-19 PHE
declared by the Secretary of Health and Human Services (HHS) on January
31, 2020, including any renewals made by the HHS Secretary in
accordance with section 319(a)(2) of the Public Health Service Act (42
U.S.C. 247d(a)(2)). As stated in the 2021 guidance, at such time when
the PHE was over, as declared by the HHS Secretary, FDA intended to
reassess the guidance. Furthermore, in the Federal Register of March
13, 2023 (88 FR 15417), FDA listed the guidance documents that will no
longer be effective with the expiration of the PHE declaration,
guidances that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration to provide a period for
stakeholder transition and then would no longer be in effect, and
guidances that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration during which time FDA
planned to further revise the guidances. The 2021 COVID-19 Methanol
Guidance is included in the latter category. Although the COVID-19 PHE
ended May 11, 2023, FDA has determined that the recommendations set
forth in the 2021 COVID-19 Methanol Guidance are applicable outside the
context of the COVID-19 PHE. FDA is, therefore, issuing this revised
final guidance, which will supersede the current guidance. In preparing
this guidance, FDA considered comments received regarding the 2021
guidance, as well as the Agency's experience with this matter during
the PHE. Updates to this guidance include removal of certain language
regarding the COVID-19 PHE, as well as removal of language related to
the three hand sanitizer guidance documents that have since been
withdrawn.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115 (21 CFR 10.115)) without initially
seeking prior comment because the Agency has determined that prior
public participation is not feasible or appropriate (see Sec.
10.115(g)(2) and section 701(h)(1)(C)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))). Specifically, we are not
seeking prior comment because, although the COVID-19 PHE has ended, the
use of hand sanitizers and other drug products containing
pharmaceutical alcohol remains widespread. Given the serious risks to
public health, including blindness and death, that can result from
methanol contamination, it is thus important to public health to
continue to apply the policy described in the guidance, which
encourages stringent and continued oversight of such products for the
possible presence of methanol.
The guidance represents the current thinking of FDA on ``Policy for
Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 71578]]
Dated: October 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22843 Filed 10-16-23; 8:45 am]
BILLING CODE 4164-01-P
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