Guidance on Drug Product Design to Minimize Errors

Federal Register Notice: FDA is making available a guidance for industry entitled Safety Considerations for Product Design to Minimize Medication Errors. The guidance is intended for sponsors of investigational new drug applications; NDAs, BLAs, ANDAs; and manufacturers of prescription drugs marketed without an approved application or over-the-counter monograph drugs. It provides a set of principles to consider while developing drug products using a systems approach to minimize medication errors related to product design and container closure design. The recommendations are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error. To download this guidance, click here. To view this notice, click here.