New FDA Requirements on Labelling and Container Labels

In April 2013, the FDA released the Guidance for Industry "Safety Considerations for Container Labels and Carton Labelling Design to Minimize Medication Errors" as a draft.

The purpose of this document is to provide a range of principles and recommendations for ensuring the correct and safe use of a pharmaceutical product.

Medication errors are a major public health concern which are estimated to cause about 7,000 deaths each year in the USA. Labelling and/ or packaging issues are responsible for around 30% of these incidents.

The Guideline addresses the following topics:

  • Poor design of product container labels and carton labelling can obscure critical safety information.
  • Risk assessment during the design stage can reduce the risk of medication errors.
  • Critical product information should appear on the principal display panel.
  • Labels should be legible, readable, and easy to understand. This includes among other things: 
          -  The container label size 
          -  The text size and style (FDA recommends a 12-point font) 
          -  Contrast of text and background colour 
          -  Information crowding and visual clutter, e.g. it is recommended to use the abbreviation "mcg" for microgram.
  • Avoid look-alike container labels and carton labelling

According to further recommendations, differentiation in the product name and strengths should be emphasized.

More detailed information can be found in the FDA document entitled "Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors".

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