[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16370-16372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05959]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1106]
Policy for Temporary Compounding of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency; Immediately in
Effect 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 guidance for industry entitled ``Policy for
Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency.'' Due to the Coronavirus Disease
2019 (COVID-19) pandemic, FDA has received a number of queries
concerning compounding of alcohol-based hand sanitizers. The Agency is
issuing this guidance to communicate its policy for the temporary
compounding of certain alcohol-based hand sanitizer products by
pharmacists in State-licensed pharmacies or Federal facilities and
registered outsourcing facilities (referred to collectively in this
notice and the guidance as compounders) for the duration of the public
health emergency declared by the Secretary of Health and Human Services
on January 31, 2020. The guidance document is immediately in effect,
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 March 23, 2020. The guidance document is immediately in
[[Page 16371]]
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:
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-1106 for ``Policy for Temporary Compounding of Certain
Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency.'' 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.
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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. 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: Rosilend Lawson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6223.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``Policy
for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer
Products During the Public Health Emergency.'' Due to the COVID-19
pandemic and the resulting public health concerns, FDA has received a
number of queries concerning compounding of alcohol-based hand
sanitizers. We understand that some consumers and healthcare
professionals are currently experiencing difficulties accessing
alcohol-based hand sanitizers containing at least 60 percent alcohol or
70 percent isopropyl alcohol. We are also aware of reports that some
consumers are producing hand sanitizers for personal use; the Agency
lacks information on the methods being used to prepare such products
and whether they are safe for use on human skin. We further recognize
that pharmacists in State-licensed pharmacies or Federal facilities and
registered outsourcing facilities (referred to collectively in this
notice and the guidance as compounders), relative to untrained
consumers, are more familiar with appropriate standards and methods for
producing drug products.
The Agency is issuing this guidance to communicate a policy for the
temporary compounding of certain alcohol-based hand sanitizer products
by compounders for consumer use and for use as healthcare personnel
hand rubs for the duration of the public health emergency declared by
the Secretary of Health and Human Services on January 31, 2020. In
light of the public health emergency posed by COVID-19, 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 Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)).
Although this guidance is immediately in effect, FDA will consider all
comments received and revise the guidance document as appropriate.
II. Significance of Guidance
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 Temporary Compounding of
Certain Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency.'' It does not establish any rights for any
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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.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collection of information for
``Current Good Manufacturing Practices for Finished Pharmaceuticals and
Medical Gases'' has been approved under OMB control number 0910-0139.
The collection of information for ``Postmarketing Adverse Drug
Experience Reporting'' has been approved under OMB control number 0910-
0230. The collection of information for ``MedWatch: Adverse Event and
Product Experience Reporting System (Paper-Based)'' has been approved
under OMB control number 0910-0291. The collection of information for
``Format and Content Requirements for Over-the-Counter Drug Product
Labeling'' has been approved under OMB control number 0910-0340. The
collection of information for ``FDA Adverse Event and Products
Experience Reports; Electronic Submissions'' has been approved under
OMB control number 0910-0645. The collection of information for
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act'' has been approved under
OMB control number 0910-0800.
IV. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05959 Filed 3-20-20; 8:45 am]
BILLING CODE 4164-01-P