Notice2022-19500
Statement of Identity and Strength-Content and Format of Labeling for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability
Primary source
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Published
September 9, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Statement of Identity and Strength--Content and Format of Labeling for Human Nonprescription Drug Products." This draft guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This draft guidance also provides recommendations on the inclusion of the drug product's strength on the labeling. The recommendations in this draft guidance are intended to help manufacturers, packers, distributors, applicants, relabelers, and sponsors ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products. Consistent content and format of the statement of identity and strength may aid consumers in comparing nonprescription drug products and assist consumers in appropriate self-selection.
Full Text
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<title>Federal Register, Volume 87 Issue 174 (Friday, September 9, 2022)</title>
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[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55438-55440]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1837]
Statement of Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug Products; Draft Guidance for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the availability of a draft guidance for industry entitled ``Statement
of Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products.'' This draft guidance provides
recommendations for the content and format of the required statement of
identity on the labeling of human nonprescription drug products. This
draft guidance also provides recommendations on the inclusion of the
drug product's strength on the labeling. The recommendations in this
draft guidance are intended to help manufacturers, packers,
distributors, applicants, relabelers, and sponsors ensure consistent
content and format of the statement of identity and strength for all
human nonprescription drug products. Consistent content and format
[[Page 55439]]
of the statement of identity and strength may aid consumers in
comparing nonprescription drug products and assist consumers in
appropriate self-selection.
DATES: Submit either electronic or written comments on the draft
guidance by November 8, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2022-D-1837 for ``Statement of Identity and Strength--Content and
Format of Labeling for Human Nonprescription Drug Products.'' 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 draft 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5493, Silver Spring, MD 20993, 301-796-6848.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Statement of Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug Products.'' This draft guidance
provides recommendations for the content and format of the required
statement of identity on the labeling of human nonprescription drug
products. This draft guidance also provides recommendations on the
inclusion of the drug product's strength on the labeling.
Labeling for nonprescription drug products is intended to enable
consumers to self-select appropriately and use the nonprescription drug
product safely and effectively without the supervision of a healthcare
practitioner. Nonprescription drug products must comply with applicable
labeling requirements for over-the-counter (OTC) products under 21 CFR
part 201, including, but not limited to, the statement of identity
under Sec. 201.61 (21 CFR 201.61). The statement of identity is one of
the principal features on nonprescription drug product labeling and
consists of the established name for the nonprescription drug product,
if one exists, followed by an accurate statement of the general
pharmacological category(ies) or the principal intended action(s) of
the drug. The labeling of all nonprescription drug products must
display the statement of identity on the product's principal display
panel (Sec. 201.61(a)).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Statement of
Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products.'' 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
This draft guidance refers to proposed collections of information
described in FDA's 60-day notice requesting public comment on the
proposed collection of information entitled ``Agency
[[Page 55440]]
Information Collection Activities; Proposed Collection; Comment
Request; General Drug Labeling Provisions and Over-the-Counter
Monograph Drug User Fee Submissions.'' The proposed 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). As required by the PRA, FDA has published an analysis of
these information collection provisions elsewhere in this edition of
the Federal Register and will submit them for OMB approval following
the period for public comment. This draft guidance also refers to
previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR part 314 have
been approved under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft 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/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>.
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19500 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P
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