Some industry representatives proposed to relax rules regarding labelling of ferrules and cap overseals but the US Pharmacopeia (USP) believes this could make it more difficult for users to see critical safety messages.
Consequently, the revised standard, which is a clearer version of a previously adopted and postponed document, limits markings on ferrules and cap overseals to vital messages, such as “Warning - Paralysing Agent” and “Dilute Before Using”.
These must be printed on the ferrule and cap overseal, except in cases where the text on the ferrule is legible under a transparent cap overseal, in a contrasting colour to ensure they are clearly visible under ordinary conditions of use.
Furthermore, the standard restricts the location of information that is important but less urgent, such as lot numbers, product or company names or logos. The standard states these may appear on the side or the ferrule but must not interfere or detract from the warning message.
For products that do not require an urgent warning the top surface must remain blank. This is to ensure that urgent warnings on other medications can be seen easily.
These revisions were decided on after the USP held discussions with medical, nursing and pharmacy workers, the pharma industry and officials and representatives from the US Food and Drug Administration (FDA).
The proposed standard will be published in USP’s Pharmacopeial Forum in January, after which there will be a 90-day timeframe for public comments. To allow stakeholders additional time to review the proposed standard the USP has published it online here.