[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