USP Labeling Standards Highlight Patient Safety

Labeling standards for ferrules and cap overseals that focus on the warnings necessary to prevent imminent life-threatening situations became official on Dec. 1, 2013, the US Pharmacopeial Convention (USP) announced in a press release.

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 USP 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 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; FDA; and other stakeholders. They were first published in the 2011 National Formulary (USP–NF), with a delayed official date of Dec. 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 Forumand provides definitions and standards for labeling of official articles. The official date of the section currently in General Chapter <1> on Labeling of Ferrules and Cap Overseals is not affected by the proposed General Chapter <7>, which has a comment deadline of Jan. 31, 2014.