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USP Clarifies Proposed Revised Standard for Labeling of Injectable Drug Vials

Tue, 11/24/2009 - 9:04am
To help prevent medication errors that can occur in busy clinical settings, the U.S. Pharmacopeial Convention (USP) is posting a proposed revised standard for what should—and what should not—appear on the ferrules and cap overseals of medications vials. Specifically, these areas must remain clear of any markings except those intended to prevent an imminent life-threatening situation. The proposed standard will be published in USP’s Pharmacopeial Forum in January for a 90-day public comment period, but is being posted on the USP Web site now to allow stakeholders additional time to review the proposal and provide comments. The proposed revision is the result of careful reviews of the current standard and consultation with medical, nursing and pharmacy practitioners, the pharmaceutical industry, and Food and Drug Administration (FDA) officials and representatives. Some industry representatives had proposed revisions to the standard that would have permitted more liberal labeling on ferrules and cap overseals of vials containing injectable medicines. After careful consideration, a USP standards-setting Expert Committee concluded that allowing additional messages would make it more difficult for practitioners to notice the most critical safety messages. Under the proposed revision, 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, life-saving piece of information that must be observed and acted upon before administering the drug to the patient. The proposed revision is similar in substance to the revision previously adopted and postponed, but has been clarified and its intent more clearly stated. The revised standard explicitly states why labeling on the ferrules and cap overseals is limited to the warnings necessary to prevent imminent life-threatening situations, and provides examples of warnings—such as “Warning - Paralyzing Agent” or “Dilute Before Using.” To further ensure that they are heeded, the proposed standard requires such warnings to be printed in a contrasting color and be clearly visible under ordinary conditions of use. There are other requirements as well, including restricting the location of information that is important but less urgent to 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 proposed revision is posted at www.usp.org/USPNF/compendialNotices . Comments on the proposed revision will be accepted through April 15, 2010, and should be directed to CapsFerrules@usp.org .

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