[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21576-21577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08335]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1005]


Safety Considerations for Product Design To Minimize Medication 
Errors; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a guidance for industry entitled 
``Safety Considerations for Product Design to Minimize Medication 
Errors.'' The guidance is intended for sponsors of investigational new 
drug applications (INDs); applicants of new drug applications (NDAs), 
biologics licensing applications (BLAs), and abbreviated new drug 
applications (ANDAs); and manufacturers of prescription drugs marketed 
without an approved application or over-the-counter (OTC) monograph 
drugs. This guidance provides sponsors, applicants, and manufacturers 
with a set of principles to consider while developing drug products 
using a systems approach to minimize medication errors relating to 
product design and container closure design. The recommendations in 
this guidance document are intended to provide best practices on how to 
improve the drug product and container closure design for all 
prescription and nonprescription drug products. This guidance also 
provides examples of product designs that resulted in postmarketing 
error.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal:http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2012-D-1005 for ``Safety Considerations for Product Design to 
Minimize Medication Errors.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the

[[Page 21577]]

``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    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: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Safety Considerations for Product Design to Minimize 
Medication Errors.'' The guidance is intended for sponsors of INDs; 
applicants of NDAs, BLAs, and ANDAs; and manufacturers of prescription 
drugs marketed without an approved application or OTC monograph drugs. 
This guidance provides sponsors, applicants, and manufacturers with a 
set of principles to consider while developing drug products using a 
systems approach to minimize medication errors relating to product 
design and container closure design. The recommendations in this 
guidance document are intended to provide best practices on how to 
improve the drug product and container closure design for all 
prescription and nonprescription drug products. The guidance also 
provides examples of product designs that resulted in postmarketing 
error.
    This guidance document, which focuses on minimizing risks 
associated with the design of the drug product and its container 
closure system, is the first in a series of three planned guidances to 
minimize or eliminate hazards contributing to medication errors. The 
second guidance focuses on minimizing risks with the design of drug 
product container labels and carton labeling. The third guidance 
focuses on minimizing risks when developing and selecting proposed 
proprietary names for drugs.
    In the Federal Register of December 13, 2012 (77 FR 74196), FDA 
announced the availability of the draft guidance entitled ``Safety 
Considerations for Product Design to Minimize Medication Errors.'' The 
Agency has carefully reviewed and considered the comments it received 
in developing this final version of the guidance. The Agency has made 
revisions to the guidance to address public comments requesting 
clarifications and implement formatting changes for improved 
readability as it deemed appropriate. The Agency also moved 
recommendations appropriate for labels and labeling to a separate 
guidance. The guidance announced in this notice finalizes the draft 
guidance dated December 2012.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on addressing safety achieved through drug 
product 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. 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

    This guidance refers to previously approved collections of 
information found in FDA regulations. 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. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014. 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.

IV. Electronic Access

    You may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08335 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P