
[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Page 24211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0401]


Draft Guidance for Industry on Safety Considerations for 
Container Labels and Carton Labeling Design To Minimize Medication 
Errors; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Safety 
Considerations for Container Labels and Carton Labeling Design to 
Minimize Medication Errors.'' The draft guidance focuses on safety 
aspects of the container label and carton labeling design for 
prescription drug and biological products. The draft guidance provides 
sponsors of new drug applications (NDAs), biologics licensing 
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 to minimize 
medication errors.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g), to ensure that the Agency considers your comments on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 24, 2013.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carol Holquist, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4416, Silver Spring, MD 20993-0002, 301-
796-0171.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 program for fiscal years (FYs) 2008 through 2012 (PDUFA IV). 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 http://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 by the end of FY 2010, after public 
consultation with academia, industry, other stakeholders, and the 
general public, the Agency would publish 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.
    This draft guidance document, which addresses safety achieved 
through the design of drug product container labels and carton labeling 
design, is the second in a series of three planned guidance documents 
to minimize risks contributing to medication errors. The first guidance 
focuses on minimizing risks with the design of drug product and 
container closure design (December 13, 2012, 77 FR 74196), and the 
third guidance will focus on minimizing risks with drug product 
nomenclature.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's current thinking on addressing safety achieved 
through drug product design to minimize medication errors. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520), before publication of the final guidance document, FDA 
intends to solicit public comment and obtain OMB approval for any 
information collections recommended in this draft guidance that are new 
or that would represent material modifications to previously approved 
collections of information found in FDA regulations.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: April 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09640 Filed 4-23-13; 8:45 am]
BILLING CODE 4160-01-P


