Originally Published PMPN March 2005
Regulatory Focus
Using Color in Drug Packaging and Labeling
FDA hopes to answer questions about color in pharmaceutical packaging and labeling.
FDA wants to know whether the use of color helps or hinders patient care.The agency’s Center for Drug Evaluation and Research (CDER) is holding a public hearing to determine how color is used in pharmaceutical packaging and labeling to help identify, classify, and differentiate drug products.
FDA has not taken a stand on the use of color. The agency was “favorably impressed” by a cooperative effort among insulin manufacturers and the International Diabetes Foundation (IDF) to use distinctive colors to identify insulin products.
In that example, color branding is used to differentiate one drug product from another. The sponsor of the program recommended color branding as a tool that could minimize errors.
Some of these types of products have since been approved, but FDA has not decided whether to implement the IDF color scheme or any other color schemes currently in use. “To date, there is little scientific evidence that applying color is effective in reducing medication errors,” FDA writes. “Furthermore, there is no validated scientific method to corroborate the benefits of using colors on pharmaceuticals in this fashion.”
Nonetheless, FDA recognizes that many in industry use or endorse the use of color schemes for pharmaceuticals. Ophthalmic, anesthetic, dental, and insulin products, as well as a number of medical devices, use color to ease identification, the agency points out. For example, some sight-challenged ophthalmic patients rely on color coding to identify their products, FDA writes. And practitioner groups often support the use of color. FDA reports that color is often used for coding, differentiation, and branding.
However, some patient safety groups argue that broad use of color has not been proven and could actually contribute to medication errors, FDA writes.
The questions that FDA hopes to answer are as follows:
• How and under what circumstances has the use of color on pharmaceutical packaging and/or labeling demonstrated an improvement in patient care?
• Are there specific classes of drugs where the use of color has demonstrated value? Are there classes where the 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?
FDA wants your input. The informal hearing was scheduled for March 7 at the National Institutes of Health (Bethesda, MD). Written and electronic comments will be accepted through April 7, and the administrative record of the meeting will be held open until then. Comments should be submitted bearing the docket number assigned to the hearing (2005N-0036) and the statement, “Use of Color on Drug Product Packaging Hearing.”
For more information on the topic, contact Mary Gross, CDER, at 301/827-3216 or via email at grossm@cder.fda.gov.
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