USP Adopts Labeling Standards for Ferrules and Cap Overseals to Protect Patient Safety

United States Pharmacopeial Convention (USP) labeling standards for ferrules and cap overseals that require warning messages with vital information aimed to prevent imminent life-threatening situations became official on December 1, 2013. “The standards explicitly state that warning messages – such as ‘Warning – Paralyzing Agent’ or ‘Dilute Before Using’ – are the only markings that should appear on ferrules and cap overseals subject to General Chapter <1> Injections, providing an additional layer of protection for healthcare practitioners prior to administering an injectable drug to a patient,” as indicated in a  USP press release (PDF).The press release also indicated that the new standards will ensure that health care providers who see a warning on a ferrule or cap overseal will have immediate knowledge of “vital, possibly life-saving information that must be observed and acted upon” before a drug is administered to a patient.

The new standards are the result of careful review and consultation between USP and medical, nursing, and pharmacy practitioners, FDA, and other stakeholders, the press release noted. The changes were first published in 2011, with a delayed official date of December 1, 2013, to give manufacturers time to comply. The location of the standard will now shift from General Chapter <1>Injections to General Chapter <7> Labeling, which is intended to be made applicable to all articles in USP-NF. This new general chapter was proposed in the November-December 2013 issue of Pharmacopeial Forum.