USP Posts Revised Standard for Labeling of Injectable Drug Vials

Last week, the US Pharmacopeial Convention (USP) posted on its website a proposed revised standard for what should and should not appear on the ferrules and cap overseals of medication vials. The revision, which is designed to prevent medication errors, states that these areas must not contain any markings except those intended to prevent an imminent life-threatening situation. If the revision were accepted, nurses, physicians, and pharmacists would be expected to know that such warnings must be observed and acted upon before administering a drug to a patient.

USP previously adopted and postponed a similar revision, but the new revision clarifies its intent. The revised standard explains why labeling on ferrules and cap overseals is limited to the warnings necessary to prevent imminent life-threatening situations and provides examples of warnings (e.g., “Warning: Paralyzing Agent” or “Dilute Before Using”). To ensure that the warnings are heeded, the proposed standard requires that they be printed in a contrasting color and be clearly visible under ordinary conditions of use.

The revised standard also contains other requirements, including restricting the location of important but less urgent information (e.g., lot numbers, product names, company names, and logos) to other parts of the vial. If no urgent warning is necessary, the top surface must remain blank to ensure that urgent warnings on other injectable medications are readily noticed.

USP carefully reviewed the current standard and consulted with medical, nursing, and pharmacy practitioners; the pharmaceutical industry; and US Food and Drug Administration officials and representatives before it drafted the proposed revision. Industry representatives suggested liberal rules for labeling, but a USP standards-setting expert committee concluded that additional messages would distract practitioners from critical safety messages.

The proposed standard will be published in USP’s Pharmacopeial Forum in January 2010 for a 90-day public comment period. The posting on the USP website is intended to allow stakeholders additional time to review the proposal and provide comments via email to CapsFerrules@usp.org, which will be accepted through Apr. 15, 2010.

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