[Federal Register: February 3, 2005 (Volume 70, Number 22)]
[Page 5687-5689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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.

Evaluation and Research (HFD-400), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3216, grossm@cder.fda.gov.


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 

    \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.)

II. Scope of the Hearing

    FDA is interested in obtaining public comment on the following 
     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 
    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.  

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]