New Standard Advanced for Labeling on Injectable Medications

(U.S. Army Corps of Engineers)

An expert committee of the United States Pharmacopeia (USP), a standards–setting body for prescription and over–the–counter medicines, has advanced a new labeling standard for injectable products, to reduce the likelihood of errors in the administration of these drugs. The new standard, to be published on 1 November 2010, applies to the top (circle) surface of the ferrule and/or cap overseal of a vial containing an injectable product.

According to the standard, only cautionary statements — those intended to prevent an imminent life-threatening situation — may appear on the top (circle) surface of the ferrule and/or cap overseal of a vial containing an injectable product. If no cautionary statement is necessary, the top surface of the vial, including the ferrule and cap overseal, must remain blank. Other statements or features — such as identifying numbers or letters, code numbers, lot numbers, company names, logos, or product names — may appear on the side surface of the ferrule on vials containing injectable products but not on the top surface of the ferrule or cap overseal.

USP says the standard’s purpose is to make it more likely that health care practitioners using injectable products will be able to better see and act on labeling statements that convey important safety messages to prevent life-threatening situations resulting from misadministration of injectable products.

USP cites reports from the Institute of Medicine, the National Coordinating Council for Medication Error Reporting and Prevention, the Institute for Safe Medication Practices, and others that indicate labeling of injectable products may be linked to medication errors in the administration of these products.