[Federal Register: February 3, 2005 (Volume 70, Number 22)]
[Notices]
[Page 5687-5689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe05-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0036]
Use of Color on Pharmaceutical Product Labels, Labeling and
Packaging; Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food
and Drug Administration (FDA) is announcing a public hearing on the
current practice of applying color to pharmaceutical product packaging
and labeling to help identify, classify, and differentiate those drug
products. To date, there is little scientific evidence that applying
color is effective in reducing medication errors. Furthermore, there is
no validated scientific method to corroborate the benefits of using
colors on pharmaceuticals in this fashion. FDA does not have a policy
pertaining to the use of colors on drug product packaging. The purpose
of the hearing is to obtain public input on the benefits and potential
drawbacks of applying color to drug packaging and labeling to help
identify, classify, or differentiate those products.
DATES: The public hearing will be held on March 7, 2005, from 8 a.m. to
4:30 p.m. Submit written or electronic notices of participation and
comments for consideration at the hearing by February 11, 2005. Written
or electronic comments will be accepted after the hearing until April
7, 2005. The administrative record of the hearing will remain open
until April 7, 2005.
ADDRESSES: The public hearing will be held at Lister Hill Auditorium,
Building 38A, on the campus of the National Institutes of Health,
Bethesda, MD (Metro stop: Medical Center Station on the Red Line).
Submit written or electronic notices of participation and comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm.
[[Page 5688]]
1061, Rockville, MD 20852; e-mail FDADockets@oc.fda.gov; or on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin. Transcripts of the
hearing will be available for review at the Division of Dockets
Management and on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://frwebgate.access.gpo,
approximately 30 days after the hearing.
FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Center for Drug
Evaluation and Research (HFD-400), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3216, grossm@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The following color techniques are used on pharmaceutical products
and medical devices:
Color Coding--Color coding is the systematic standard
application of color to aid in the classification and identification of
drug products. A color coding system allows people to memorize a color
and match it to its function.
Color Differentiation--Color differentiation involves the
use of color to make certain features on the package stand out or to
help distinguish one item from another. The color itself is not a
standard code that is applied systematically to classify and identify
the product, as with color coding.
Color Branding--Color branding is a newly applied concept
introduced by a single manufacturer of insulin products. Color branding
is used to differentiate one drug product from another and is managed
by the individual sponsor. The sponsor recommended this tool in an
effort to minimize error between an insulin analogue and another
product containing a mix of insulin analogues.
Color Matching--Color matching is sometimes applied in an
effort to reduce the risk of errors. For example, a medical device may
have a blue plug that attaches to a blue receptacle and a yellow plug
that attaches to a yellow receptacle. However, the colors have no
special meaning beyond matching one item with another.
In the Federal Register of May 13, 1998 (63 FR 26694), FDA
published a direct final rule entitled ``Removal of Regulations
Regarding Certification of Drugs Composed Wholly or Partly of
Insulin.'' Included in the rule was the removal of Sec. 429.12 (21 CFR
429.12) that contained a distinguishing color scheme for insulin
products. At that time, the agency was favorably impressed with the
cooperative effort between the insulin manufacturers and the
International Diabetes Foundation (IDF) that resulted in a new color
coding system in which each insulin product would be identified with a
distinctive color. Although some insulin products have been approved
with the IDF colors, the agency has not taken a position on whether to
fully implement the IDF color scheme for insulin products, nor has FDA
taken a public position on the acceptability of adopting any other
color scheme currently in use.
A number of drug product and device manufacturers use color schemes
as described previously in this document in an effort to facilitate the
selection and dispensing of drugs. For example, ophthalmic, anesthetic,
dental, and insulin drug products, as well as medical devices, all use
color to classify, identify, or differentiate drugs among the same
class or facilitate the correct use of medical devices. Individual
practitioner groups often endorse the use of colors to help
differentiate among drugs. Many drugs are marketed with similar
labeling and labels which contributes to an already complex prescribing
and dispensing environment. Sight challenged ophthalmic patients count
on color coding to identify their products. Patient safety groups,
however, argue that broad application of color techniques is unproven,
controversial, and could be a contributing factor in medication
errors.\1\
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\1\Citations regarding the role of color coding and medication
error reduction may be accessed at Report 5 of the Council on
Scientific Affairs (A-04) Full Text--The Role of Color Coding in
Medication Error Reduction. The article is accessible at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ama-assn.org/ama/pub/category/13662.html
(FDA has verified the
Web site address but is not responsible for subsequent changes to
the Web site after this document publishes in the Federal Register.)
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II. Scope of the Hearing
FDA is interested in obtaining public comment on the following
issues:
How and under what circumstances has the use of color on
pharmaceutical packaging and/or labeling demonstrated an improvement in
patient care? If there is no discernible improvement, please describe
what you consider to be deficiencies in the program.
Are there specific classes of drugs where use of color has
demonstrated value? Are there classes where use of color is a hindrance
to public safety?
Are there drug products currently marketed that do not use
color but should use color to aid in identification of the drug? If so,
how should color be used?
How should the effectiveness of application of color on
drug products be scientifically validated?
III. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs (the Commissioner) is announcing
that the public hearing will be held in accordance with part 15 (21 CFR
part 15). The presiding officer will be the Commissioner or his
designee. The presiding officer will be accompanied by a panel of FDA
employees with relevant expertise.
Persons who wish to participate in the part 15 hearing must file a
written or electronic notice of participation with the Division of
Dockets Management (see ADDRESSES and Dates). To ensure timely
handling, any outer envelope should be clearly marked with the docket
number listed in brackets in the heading of this notice along with the
statement ``Use of Color on Drug Product Packaging Hearing.'' Groups
should submit two written copies. The notice of participation should
contain the potential presenter's name; address; telephone number;
affiliation, if any; the sponsor of the presentation (e.g., the
organization paying travel expenses or fees), if any; a brief summary
of the presentation; and the approximate amount of time requested for
the presentation. The agency requests that interested persons and
groups having similar interests consolidate their comments and present
them through a single representative. After reviewing the notices of
participation and accompanying information, FDA will schedule each
appearance and notify each participant of the time allotted to the
presenter and the approximate time that presenter's oral testimony is
scheduled to begin. If time permits, FDA may allow interested persons
attending the hearing who did not submit a written or electronic notice
of participation in advance to make an oral presentation at the
conclusion of the hearing. The hearing schedule will be available at
the hearing. After the hearing, the schedule will be placed on file in
the Division of Dockets Management (see ADDRESSES) under the docket
number listed in brackets in the heading of this notice.
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (21 CFR part 10, subpart C). UnderSec. 10.205
[[Page 5689]]
(21 CFR 10.205), representatives of the electronic media may be
permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec. 15.30(b). The transcript will be available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets, and orders for copies of
the transcript can be placed at the meeting or through the Division of
Dockets Management (see ADDRESSES).
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see FOR
FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec.
15.30(h).
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic notices of participation and
comments for consideration at the hearing (see DATES). Submit a single
copy of written or electronic notices of participation and comments, or
two paper copies of any mailed notices of participation and comments,
except that individuals may submit one 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.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2094 Filed 1-31-05; 3:37 pm]
BILLING CODE 4160-01-S