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Excipient Nomenclature:

Are you using the right name on your label?

How does USP name pharmaceutical excipients? Who determines what name is “right”? How does excipient nomenclature affect quality? Are you sure you are using the intended ingredient? Questions surrounding the naming of pharmaceutical excipients can have far-reaching implications for drug formulation development, manufacturing and distribution, including setting specifications for identification, assays and impurities, as well as labeling requirements and overall drug safety.

USP invites you to attend our Excipient Nomenclature workshop on August 7, 2018 in Rockville, MD and online via WebEx. At this workshop, USP will provide a unique, interactive opportunity for formulators, innovators, quality and regulatory affairs professionals from generic, innovative and OTC drug product and excipient manufacturers to hear from and dialogue with FDA and USP on procedures and issues surrounding the official nomenclature and labeling of pharmaceutical excipients.

Topics planned for USP's comprehensive all-day workshop in Rockville, MD and online include:

Introduction to Global Substance Registration System (GSRS):

  • Its purpose and role in naming pharmaceutical excipients
  • Understanding the database
  • Background and basis for Unique Ingredient Identifiers (UNIIs)
  • How are decisions made for naming excipients?
  • Alignment among GSRS (UNII code), FDA CDER Inactive Ingredient Database (IID) and USP in determining excipient naming and labeling

Regulatory, pharmacopeial and industry perspectives on nomenclature policies and issues, and their effects on labeling, quality and standards setting

Case studies and open discussion presented by industry leaders identifying current challenges and opportunities with naming excipients including:

  • What do we mean by excipient grade?
  • When is grade important to excipient naming?
  • When should Pharmacopeias, Regulatory, and Industry care about grade?
  • Impact of labeling and mapping of UNIIs on nomenclature

Questions? Please contact us at conferences@usp.org or (301) 816-8130.
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