[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30227-30229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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finalizes the draft guidance of the same title issued on April 24, 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: 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.
    <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 https://www.regulations.gov 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 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 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 https://wayback.archive-it.org/7993/20171115015358/https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm). 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

[[Page 30229]]

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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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