Mission  

The Consortium for the Advancement of Patient Safety (CAPS) is an educational consortium initiated to educate and promote awareness on the benefits of printing on drug packaging, specifically secondary closures, to mitigate medication errors and improve patient safety.  

Issue Overview

The United States Pharmacopeia (USP), a standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the United States, is revising the General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals to limit printing and other types of messaging on drug packages.

When the revision is implemented in May of 2010, printing would be limited to cautionary statements on the top surface of the ferrule or cap overseal of an injectable drug product. A cautionary statement is intended to prevent an imminent life-threatening situation if the injectable drug is used inappropriately.

CAPS members believe that limiting the type of information that can be printed or otherwise displayed on vial ferrules and cap overseals could be detrimental to patient safety and to efforts that help combat drug counterfeiting. Pharmaceuticals manufacturers use the ferrule and cap overseal as a platform for anti-counterfeiting technology, and to display information on dosage, cold chain management and point-of-use administration instructions as a means of preserving patient safety.

The USP welcomes and encourages any comments on potential, proposed or official standards. Please contact the USP to communicate your views on how the printing restrictions could be detrimental to the safe and intended use of drug products.

The USP welcomes and encourages any comments on potential, proposed or official standards. Please respond to the USP to communicate your views on how the printing restrictions could be detrimental to the safe and intended use of your drug products.