[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18514-18516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0168]


Developing Guidance on Naming, Labeling, and Packaging Practices 
to Reduce Medication Errors; Public Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Developing Guidance on Naming, Labeling, and 
Packaging Practices to Reduce Medication Errors.'' The purpose of the 
public workshop is to initiate constructive dialogue and information 
sharing among regulators, researchers, the pharmaceutical industry, 
health care organizations, health care professionals, and others from 
the general public about the design of drug and therapeutic biologic 
container labels, carton labeling, and product packaging, and practices 
to develop proprietary names to reduce medication errors. The input 
from this workshop will be used to develop draft guidance for industry 
on practices for naming, labeling, and packaging of drugs and biologics 
to reduce the potential for medication errors. FDA is also opening a 
public docket to receive comments on this topic to assist in the 
development of draft guidance.

DATES AND TIME:  The public workshop will be held on Thursday and 
Friday, June 24 and 25, 2010, from 8:30 a.m. to 5 p.m. each day. 
Register to make a presentation at the workshop by May 25, 2010. See 
section IV of this document for information on how to attend or present 
at the meeting. Submit written or electronic comments to the docket by 
July 23, 2010, to receive consideration.

ADDRESSES:  The public workshop will be held at the Marriott Residence 
Inn at 7335 Wisconsin Ave., Bethesda, MD 20814. Submit electronic 
requests to register and make a presentation to 
[email protected]. Submit written requests to register and make 
a presentation to Colleen O'Malley (see FOR FURTHER INFORMATION 
CONTACT).
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Colleen O'Malley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4305, Silver Spring, MD 20993, 301-796-
1786, FAX: 301-796-9832, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In title I of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Public Law 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 the 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, and others from the general public, the agency 
would publish a draft guidance describing practices for naming, 
labeling, and packaging drugs and biologics to reduce medication 
errors.

II. Workshop Objectives and Issues for Discussion

    This workshop represents the first step in meeting the PDUFA goal 
described previously and is intended to provide valuable information to 
assist the agency in developing draft guidance for industry on 
practices to reduce medication errors. The workshop will not discuss 
the ongoing FDA pilot program to evaluate proposed proprietary name 
submissions. Persons seeking more information on the pilot program 
should refer to the FDA concept paper entitled ``PDUFA Pilot Project 
Proprietary Name Review'' at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance/ucm072229.pdf and the 
Federal Register notice entitled ``Pilot Program to Evaluate Proposed 
Proprietary Name Submissions; Procedures to Register for Participation 
and Submit Data'' (74 FR 50806, October 1, 2009) announcing procedures 
for participation in the voluntary pilot program.
    The workshop objectives are as follows: (1) Initiate constructive 
dialogue and information sharing among regulators, researchers, the 
pharmaceutical industry, health care organizations, health care 
professionals, and others from the general public about the design of 
drug and therapeutic biologic container labels, carton labeling, and 
product packaging, and practices in developing proprietary

[[Page 18515]]

names to reduce medication errors; (2) share current FDA experience 
regarding the evaluation of labels, packaging, and proprietary names; 
and (3) obtain input on developing consistent review criteria for FDA 
to use in evaluating container labels, carton labeling, and product 
packaging submitted to the agency. FDA will use information from the 
workshop to help develop a draft guidance for manufacturers and 
distributors for creating product names and designing product labels 
and packaging to reduce medication errors.
    Four panel discussions will focus on areas in which the agency 
requests input.
    Panel 1 will focus on characteristics of container label and carton 
labeling design as they relate to reducing the risk of medication 
errors. Topics with respect to container label and carton labeling 
design include content, format, type of label, layout, use of color, 
use of graphics, and costs associated with designing labels.
    Panel 1 will address the following questions:
    1. What does FDA need to consider to ensure that the container 
labels and carton labeling designs are safe and reduce the risk of 
medication errors?
    2. What are the challenges in designing container label and carton 
labeling to reduce the risk of medication errors?
    3. What are some strategies for addressing these design challenges 
without compromising safety?
    Panel 2 will focus on characteristics related to study design, 
conduct and interpretation of human factors analysis, Failure Mode and 
Effects Analysis (FMEA), usability studies, and other studies 
specifically focused on evaluating the safety of container label and 
carton labeling designs to reduce the risk of medication errors. Topics 
include methodology, selection of participants and subjects, collection 
of data, analysis of data, costs and time to conduct such studies, and 
interpretation of study findings.
    Panel 2 will address the following questions:
    1. What are the strengths and limitations of performing such 
studies?
    2. Are there other types of studies and analyses that provide 
useful information about the medication error risks associated with the 
container label or carton labeling design?
    3. How can FDA ensure that the study design accurately captures and 
assesses potential medication error risks that should be considered in 
our evaluation of the container labels and carton labeling?
    Panel 3 will focus on characteristics of the manufacturers' 
packaging used for medications as they relate to the safe use of the 
medicine from a medication errors perspective. Topics include 
medication error considerations when designing a container-closure 
system for a medication, drug-device combination packaging, studies and 
analyses to evaluate the safety of product packaging design, and costs 
associated with designing product packaging.
    Panel 3 will address the following questions:
    1. What information does FDA need to consider to ensure that the 
manufacturers' packaging design is safe and reduces the risk for 
medication errors?
    2. What are the challenges in designing manufacturers' packaging to 
reduce the risk of medication errors?
    3. What are some strategies for addressing these challenges without 
compromising safety?
    4. How can FDA ensure that the study design accurately captures and 
assesses potential medication error risks that should be considered in 
our evaluation of a proposed manufacturers' packaging design for a 
particular medication?
    5. Are there other types of studies and analyses that provide 
useful information about the medication error risks associated with the 
manufacturers' packaging design?
    Panel 4 will focus on recommended practices in developing 
proprietary names as they relate to reducing medication errors. Topics 
include choosing a nomenclature strategy for new products containing 
the same active ingredient as marketed products; selection and 
application of modifiers to proprietary names; and medication error 
potential from use of the same proprietary name as a component of the 
proprietary names for multiple products containing different active 
ingredients; U.S. Adopted Names (USAN) Council Stems; medical 
abbreviations; encoding dosage forms or dosing intervals; and including 
the established name or ingredients within the proprietary name.
    Panel 4 will address the following questions:
    1. What are the challenges in developing a proprietary name from a 
safety perspective to prevent medication errors?
    2. What are some strategies for addressing these challenges without 
compromising safety?
    3. When products are developed containing the same ingredient as a 
marketed product, how can risks associated with a given nomenclature 
strategy for the proposed product be evaluated, minimized, and 
mitigated (e.g., use of a modifier ``Proprietary XL'' versus the use of 
an alternate proprietary name)?

III. Comments

    Regardless of attendance at the public workshop, interested persons 
may submit written or electronic comments to the Division of Dockets 
Management (see ADDRESSES). Submit a single copy of electronic comments 
or two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified 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.

IV. Attendance and Registration

    There is no fee to attend the workshop, and attendees who do not 
wish to make a formal presentation do not need to register. Seating 
will be on a first-come, first-served basis.
    If you would like to make an oral presentation to the panelists 
during the meeting, you must register by mail or email (see ADDRESSES) 
and provide an abstract of your presentation by 5 p.m. on May 25, 2010. 
You must also provide your name, title, business affiliation (if 
applicable), address, telephone and fax numbers, and e-mail address. 
Identify the panel number and question number(s) you will address in 
your presentation.
    FDA will do its best to accommodate requests to speak. Individuals 
and organizations with common interests are urged to consolidate or 
coordinate their presentations and request time for a joint 
presentation. FDA will determine the amount of time allotted to each 
presenter and the approximate time that each oral presentation is 
scheduled to begin. Persons registered to make a formal presentation 
should check in before the workshop. Ample time will be allowed during 
the scheduled agenda for attendees who have not registered to ask 
questions of the panelists. In addition, we strongly encourage written 
comments to the docket.
    If you need special accommodations because of disability, please 
contact Colleen O'Malley (see FOR FURTHER INFORMATION CONTACT) at least 
7 days before the workshop.

V. Transcripts

    Please be advised that as soon as a transcript of the workshop is 
available, it will accessible at http://www.regulations.gov. It may be 
viewed at the Division of Dockets Management

[[Page 18516]]

(see ADDRESSES). A transcript will also be made available in either 
hard copy or on a CD-ROM upon submission of a Freedom of Information 
request. Written requests are to be sent to Freedom of Information 
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, 
Rockville, MD 20857.

    Dated: March 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8233 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S