Wednesday 15 May 2013

FDA Releases Draft Guidance on Labeling Safety

The FDA has issued the following draft guidance:

"Guidance for Industry Safety Considerations for Container  Labels and Carton Labeling Design to  Minimize Medication Errors".

The introduction to the document states:

"The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of the container label and carton labeling design, and provides a set of principles and  recommendations for ensuring that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.

This guidance applies to prescription drug and CDER-regulated biological products, including the following:
  • Prescription drug products marketed under an approved new drug application (NDA) or abbreviated new drug application (ANDA); 
  • Prescription drugs marketed without an approved NDA or ANDA; and 
  • Biological products marketed under an approved biologics licensing application (BLA)."
Further inside, the FDA has several recommendations on
  • Proprietary, Established, and Proper Names
  • Product Strength
  • Route(s) of Administration
  • Warnings for Critical Information
  • Expiration Dates
  • Bar Codes
  • National Drug Code Numbers
  • Controlled Substance Schedule
To access the document, see FDA.

Posted by Tim Sandle

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