Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry; Availability, 71576-71578 [2023-22843]
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71576
Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–22809 Filed 10–16–23; 8:45 am]
BILLING CODE 4184–41–P
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.
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:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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17:02 Oct 16, 2023
Jkt 262001
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.
• 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:
• 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.
• 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 https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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
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redacted/blacked out, will be available
for public viewing and posted on
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-201509-18/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; 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,
E:\FR\FM\17OCN1.SGM
17OCN1
Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices
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:
lotter on DSK11XQN23PROD with NOTICES1
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 Statelicensed 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 finishedproduct test methods to ensure that
when testing for ethanol or isopropyl
alcohol content (assay), the method also
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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 (§ 10.115 (21 CFR
10.115)) without initially seeking prior
comment because the Agency has
determined that prior public
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71577
participation is not feasible or
appropriate (see § 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 https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
E:\FR\FM\17OCN1.SGM
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71578
Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–3682]
Determination That ZOFRAN ODT
(Ondansetron) Orally Disintegrating
Tablets, 4 Milligrams and 8 Milligrams,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined that ZOFRAN ODT
(ondansetron) orally disintegrating
tablets, 4 milligrams (mg) and 8 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
the products as long as they meet
relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Veniqua Stewart, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002, 301–
796–3267, Veniqua.stewart@
fda.hhs.gov.
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:02 Oct 16, 2023
Jkt 262001
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg,
are the subject of NDA 020781, held by
Sandoz Inc., and initially approved on
January 27, 1999. ZOFRAN ODT is
indicated for the prevention of nausea
and vomiting associated with: highly
emetogenic cancer chemotherapy,
including cisplatin greater than or equal
to 50 mg/m2; initial and repeat courses
of moderately emetogenic cancer
chemotherapy; and radiotherapy in
patients receiving either total body
irradiation, single high-dose fraction to
the abdomen, or daily fractions to the
abdomen. ZOFRAN ODT is also
indicated for the prevention of
postoperative nausea and/or vomiting.
ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg,
are currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Sun Pharmaceutical Industries
Limited submitted a citizen petition
dated August 24, 2023 (Docket No.
FDA–2023–P–3682), under 21 CFR
10.30, requesting that the Agency
determine whether ZOFRAN ODT
(ondansetron) orally disintegrating
tablets, 4 mg and 8 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ZOFRAN ODT
(ondansetron) orally disintegrating
tablets, 4 mg and 8 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
has identified no data or other
information suggesting that ZOFRAN
ODT (ondansetron) orally disintegrating
tablets, 4 mg and 8 mg, were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that these
drug products were not withdrawn from
sale for reasons of safety or
effectiveness.
Accordingly, the Agency will
continue to list ZOFRAN ODT
(ondansetron) orally disintegrating
tablets, 4 mg and 8 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to these
drug products. Additional ANDAs for
these drug products may also be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22844 Filed 10–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4067]
Diabetic Foot Infections: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Diabetic
Foot Infections: Developing Drugs for
Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the
SUMMARY:
E:\FR\FM\17OCN1.SGM
17OCN1
Agencies
[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Pages 71576-71578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22843]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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:
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.
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 https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
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 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; 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
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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
[[Page 71578]]
Dated: October 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22843 Filed 10-16-23; 8:45 am]
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