November 15, 2011: New USP Requirement for Drug Vial Caps and Ferrules
The United States Pharmacopeia (USP) has finalized a standard that allows only cautionary statements intended to prevent imminent life-threatening situations to be printed on the cap or ferrule (the metal band holding a stopper in place) of a drug vial. One example of such a cautionary statement is the warning that appears on caps and ferrules of neuromuscular blocking agents (e.g., “Warning–Paralyzing Agent”). If the medication does not need a cautionary statement, this area of the vial must remain blank. These new requirements, which come into effect on December 1, 2013, are intended to make it more likely that doctors, nurses, pharmacists, and other healthcare practitioners will see and act on the labelling statements that appear on injectable products. Manufacturers using USP standards will need to provide a rationale if they want to include a cautionary statement in this location. Under the new requirements, other information will still be permitted elsewhere on the medication vial.Additional information on this USP standard is available from: www.usp.org/USPNF/notices/ferrulesCapOverseals.html
