Are you aware that UNIIs from the IID are now listed in USP monographs?
Is this causing your customers issues when selecting excipients? Are you getting questions from your customers or are your customers reluctant to use excipients and/or excipient grades that have not been assigned a UNII? Or for excipients already assigned a UNII, the assigned UNII is not listed in the IID or excipient monograph?
IPEC-Americas is working with the United States Pharmacopeia (USP) to plan for an upcoming workshop entitled “What’s in a Name? Impact of Nomenclature on Excipient Quality, Drug Product Development and Labeling Compliance.” The workshop, sponsored by USP, will be held on August 7, 2018. In addition to several invited U.S. FDA speakers who will provide an introduction, overview and regulatory perspective of the Global Substance Registration System (GSRS) and Substance Registration System (SRS), USP will provide a Pharmacopeial perspective on excipient nomenclature and challenges, and industry will provide their perspective on this topic.