FDA Issues Labelling Guidance

Safety - Issues, Errors, and Problems on medication?

The final guidance focuses on safety aspects of container label and carton labelling design.

FDA published final guidance on May 18, 2022 to help drug industries to minimize medication errors. The guidance, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, focuses on safety aspects of container labels and carton labeling design by providing principles and recommendations to ensure a product’s label and carton promote safe dispensing, administration, and use.

The document details the impact poor label design can have on safety and the importance of risk assessments. Label size, text size, and abbreviations are among the specific label qualities addressed. The guidance also discusses name, lettering, product strength, route of administration, warnings, expiration dates, and other packaging information.

Here is some of the point focus on this guidelines

• Poor Design of Product Container Labels and Carton Labeling 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.
• Container Labels and Carton Labeling Should be Legible, Readable, and Understandable.
• Avoid Look-Alike Container Labels and Carton Labeling.
• There Should Be Consistency Between the Container Label and Carton Labeling and Other Approved Labeling.

SPECIAL CONSIDERATIONS AND RECOMMENDATIONS

• Proprietary, Established, and Proper Names
• Tall Man Lettering
• Product Strength
• Route(s) of Administration
• Warning or Cautionary Statement(s)
• Expiration Dates and Beyond-Use Dates
• Barcodes
• National Drug Code Numbers
• Controlled Substance Schedule

Buy Basic Concepts of Track And Trace System For Pharmaceutical Industry Book Online at Low Prices in India | Basic Concepts of Track And Trace System For Pharmaceutical Industry Reviews & Ratings - Amazon

Special Edition: Tall Man Lettering; ISMP Updates Its List of Drug Names with Tall Man Letters | Institute For Safe Medication Practices