FDA Issues Final Guidance on Container Closure Systems to Reduce Medication Errors

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-12-2016 14:58


The US Food and Drug Administration has issued final guidance, Safety Considerations for Product Design to Minimize Medication Errors to provide a set of principles for using a systems approach to minimize medication errors relating to product design and container closure design for enhancing patient safety. The recommendations are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drugs and biologic products regulated by the Center for Drug Evaluation and Research.

The guidance also provides examples of product designs that have resulted in postmarketing medication errors. The guidance points out that medication errors can be avoided at the design stage by drawing on lessons learned from past medication errors and by conducting proactive risk assessments before marketing. The guidance does not describe how to conduct, document, and submit risk assessments, or how such assessments, if conducted, will be evaluated by the agency.

This guidance, which focuses on minimizing risks associated with the design of the drug product and its container closure system, is the first in a series of three planned guidances to minimize or eliminate hazards contributing to medication errors at the product design stage. The second guidance focuses on minimizing risks associated with the design of drug product container labels and carton labeling, and the third focuses on minimizing risks when developing and selecting proposed proprietary names.

Source: US Food and Drug Administration


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