Notice2022-10699
Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Guidance for Industry; Availability
Primary source
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Published
May 18, 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 final guidance for industry entitled "Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors." The guidance focuses on safety aspects of the container label and carton labeling design for human prescription drug and biological products. The guidance provides sponsors of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product. This guidance finalizes the draft guidance of the same title issued on April 24, 2013.
Full Text
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<title>Federal Register, Volume 87 Issue 96 (Wednesday, May 18, 2022)</title>
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[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30227-30229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0401]
Safety Considerations for Container Labels and Carton Labeling
Design To Minimize Medication Errors; 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 ``Safety
Considerations for Container Labels and Carton Labeling Design to
Minimize Medication Errors.'' The guidance focuses on safety aspects of
the container label and carton labeling design for human prescription
drug and biological products. The guidance provides sponsors of new
drug applications (NDAs), biologics license applications (BLAs),
abbreviated new drug applications (ANDAs), and prescription drugs
marketed without an approved NDA or ANDA with a set of principles and
recommendations for ensuring that critical elements of product
container labels and carton labeling are designed to promote safe
dispensing, administration, and use of the product. This guidance
finalizes the draft guidance of the same title issued on April 24,
2013.
DATES: The announcement of the guidance is published in the Federal
Register on May 18, 2022.
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'').
[[Page 30228]]
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-2013-D-0401 for ``Safety Considerations for Container Labels and
Carton Labeling Design to Minimize Medication Errors.'' 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 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; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Irene Z. Chan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301-
796-3962; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Safety Considerations for Container Labels and Carton
Labeling Design To Minimize Medication Errors.'' In Title I of the Food
and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-
85), Congress reauthorized and expanded the Prescription Drug User Fee
Act (PDUFA) program for fiscal years 2008 through 2012. As part of the
performance goals and procedures set forth in an enclosure to the
letter from the Secretary of Health and Human Services referred to in
section 101(c) of FDAAA, FDA committed to certain performance goals and
procedures. (See <a href="https://wayback.archive-it.org/7993/20171115015358/https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm">https://wayback.archive-it.org/7993/20171115015358/https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm</a>). In that letter, FDA stated that it would use fees
collected under PDUFA to implement various measures to reduce
medication errors related to look-alike and sound-alike proprietary
names, unclear label abbreviations, acronyms, dose designations, and
error-prone label and packaging designs. Among these measures, FDA
agreed that, after public consultation with academia, industry, other
stakeholders, and the general public, the Agency would publish a draft
guidance describing practices for naming, labeling, and packaging drugs
and biologics to reduce medication errors. On June 24 and 25, 2010, FDA
held a public workshop and opened a public docket (Docket No. FDA-2010-
N-0168) to receive comments on these measures. After reviewing public
input, a draft guidance was subsequently published by FDA in April 2013
(Docket No. FDA-2013-D-0401). Additional public comment was provided
through a docket. This guidance presents FDA's final recommendations
and conclusions after having reviewed this public input and considered
information learned through evaluating postmarketing medication errors.
This guidance is intended to help entities holding NDAs, BLAs, and
ANDAs and entities manufacturing or distributing prescription drugs
marketed without an approved application. This guidance focuses on
safety aspects of the application holder's container label and carton
labeling design, and it provides a set of principles and
recommendations for ensuring that critical elements of a product's
container label and carton labeling are designed to promote safe
dispensing, administration, and use of the product.
The recommendations in this guidance are intended to provide best
practices on how to improve the container label and carton labeling of
prescription drug and biological products to minimize medication
errors. The guidance also provides examples of container label and
carton labeling designs that resulted in postmarketing medication
errors.
This guidance finalizes the draft guidance entitled ``Safety
Considerations for Container Labels and Carton Labeling Design to
Minimize Medication Errors'' published in the Federal Register of April
24, 2013 (78 FR 24211). FDA considered comments received on the draft
guidance as the guidance was finalized. Changes from the draft to the
final guidance include revisions to clarify language that some
commenters considered unnecessarily restrictive and emphasize that
labeling statements should be considered within a risk framework. In
addition, the guidance has been updated to reflect regulations and
policy that have been established since the draft guidance was
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published. Furthermore, editorial changes were made to improve clarity.
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 ``Safety Considerations for Container Labels
and Carton Labeling Design to Minimize Medication Errors.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. 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 601
have been approved under OMB control number 0910-0338. The collections
of information in 21 CFR part 203 described in the final rule entitled
``Prescription Drug Marketing Act of 1987; Prescription Drug Amendments
of 1992; Policies, Requirements, and Administrative Policies'' have
been approved under OMB control number 0910-0435. The collections of
information in part 201 (21 CFR part 201) described in the final rule
entitled ``Bar Code Label Requirement for Human Drug Products and
Biological Products'' have been approved under OMB control number 0910-
0537. The collections of information for prescription drug product
labeling in Sec. 201.56 and 201.57 (21 CFR 201.56 and 201.57) have
been approved under OMB control number 0910-0572. The collections of
information described in the FDA guidance for industry entitled ``Drug
Supply Chain Security Act Implementation: Identification of Suspect
Product and Notification'' have been approved under OMB control number
0910-0806.
In addition, the inclusion of warning statements on labels for
certain drug products would be exempt from review by OMB under the PRA
because the public disclosure of information originally supplied by the
Federal government to the recipient for the purpose of disclosure to
the public is not included within the definition of ``collection of
information'' (see 5 CFR 1320.3(c)(2)).
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/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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: May 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10699 Filed 5-17-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 18, 2022.
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