USP–NF Excipients: Challenges & Opportunities

Challenges and Opportunities in Updating USP-NF Excipients

In 2010, USP embarked on a comprehensive modernization initiative to bring its standards compendia, the United States Pharmacopeia—National Formulary (USP–NF)up to date, striving to ensure that all monographs and general chapters in the USP–NF—including those for drug products, drug substances, excipients, biologics, and dietary supplements—are current, relevant, and suitable for their intended use.
Increasing concerns about the effect of globalization on the integrity and transparency of the excipient supply chain, and hence quality and safety, led FDA to form a Monograph Modernization Task Group  to lend support to the USP initiative. The group comprises members from the Center for Drug Evaluation and Research and the Office of Regulatory Affairs. A list of 19 excipient monographs was subsequently identified as high priority for update in three letters from FDA to USP.
The following article describes USP’s comprehensive approaches for updating several high-priority excipient monographs—Guar Gum, Shellac, and Butylated Hydroxytoluene—and discusses the challenges encountered and progress made by USP in implementing the initiative to develop up-to-date USP–NF excipient monographs.