[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] The European Commission (EC) released a draft revision of the “Excipients in the label and package leaflet of medicinal products for human use” (CPMP/463/00 Rev. 1) annex covering the use of sodium-containing excipients. The nine-page draft, in the form of a Q&A document, was released in late June for a three-month public consultation. The Q&A covers: ● what sodium is and why is it used as an excipient ● safety concerns, and ● the reasons manufacturers need to update the package leaflet. Also included is a comparison of the 2003 guideline and the proposed revisions.