FDA´s new Guidance on Readability

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The U.S. FDA published a new guidance on safety considerations for container labels and carton labeling design. According to the agency, the purpose of the guidance is to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products. It provides a set of principles and recommendations for ensuring that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration, and use of the product.

Although the guidance does not apply to over-the-counter (OTC) drug products, compounded products, marketed prescription products used in clinical or bioequivalence studies, or investigational medicinal products (IMPs), the principles outlined in this guidance may still be useful for such products.

Container labels and carton labeling should be legible, readable, and understandable

The agency recommends that the text on the container label and carton labeling should be:

• in general, oriented in the same direction;
• placed in the same field of vision (i.e., readable without having to turn or rotate the container); 
• surrounded by sufficient blank space to improve readability and to avoid crowding.

Text size and style

Where feasible for container labels and carton labeling, persons responsible for designing product container labels and carton labeling should choose fonts that are not lightweight (i.e., thin font) or condensed such that legibility is compromised. A number of published references recommend a larger font size, such as 12-point sans serif (e.g., Arial), to improve readability (e.g., recommendations by the National Patient Safety Agency and USP). However, the FDA recommends the use of an appropriate size and style of font that improves readability within the confines of the label size.

More information is provided in FDA´s Guidance for Industry Safety considerations for container labels and carton labeling design to minimize medication errors.