Labeling standards that focus on the warnings necessary to prevent imminent life-threatening situations, established by the U.S. Pharmacopeial Convention (USP) for ferrules and cap overseals, became official on Dec. 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.
Under the standards, if a nurse, physician, or pharmacist sees a warning on a ferrule or cap overseal, he or she will know immediately that it is a vital, possibly life-saving piece of information that must be observed and acted upon before administering the drug to the patient.
The standard indicates that ferrules and cap overseals must remain clear of any markings, including logos, except those intended to prevent an imminent life-threatening situation. Products that do not require cautionary statements should be free of information, so that those with cautionary statements are immediately apparent.
The standards also require that such warnings to be printed in a contrasting color and be clearly visible under ordinary conditions of use. Other requirements include restricting the location of information that is important but less urgent to be located elsewhere on the vial. This would include, for example, lot numbers, product or company names, and logos. If no urgent warning is necessary, the top surface must remain blank to help ensure that urgent warnings on other injectable medications are readily noticed.
The standards are the result of careful reviews and consultation between USP and medical, nursing, and pharmacy practitioners, the U.S. Food and Drug Administration, and other stakeholders. They were first published in the 2011 U.S. Pharmacopeia and the National Formulary (USP–NF)—USP’s compendia of public quality standards—with a delayed official date of December 1, 2013, to allow manufacturers time to comply with the standard.
While these labeling standards for ferrules and cap overseals became official in General Chapter <1> Injections in USP–NF, the location of the standard will shift to General Chapter <7> Labeling, which is intended to be made applicable to all articles in USP-NF. This new general chapter has been proposed in the November–December 2013 issue of Pharmacopeial Forum—USP’s free-access, online publication for posting proposals and receiving public comments to its developing standards—and provides definitions and standards for labeling of official articles. The official date of the section currently in <1> on Labeling of Ferrules and Cap Overseals is not affected by the proposed General Chapter <7> (comment deadline is January 31, 2014).
USP is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are used worldwide. For more information about USP visit http://www.usp.org. FY1419.
