CHPA member companies are undertaking an unprecedented effort: to collectively, as an industry, help update the United States Pharmacopeia’s (USP’s) National Formulary (NF) monographs.
The combined FDA/USP/CHPA Planning Committee is working on modernizing USP-NF monographs for small molecules and excipients to ensure all:
- Utilize current technology;
- Incorporate safety advancements; and
- Address key quality aspects, such as impurities thresholds.
As part of USP's initiative to update and improve its monographs for drug substances and products in the USP–NF compendia, USP—and therefore the planning committee—is focusing on monographs identified as a priority by the U.S. Food and Drug Administration.