USP Monograph Modernization

CHPA member companies are undertaking an unprecedented effort to collectively, as an industry, help update the U.S. Pharmacopeia’s (USP) National Formulary (NF) monographs.

The combined U.S. Food and Drug Administration (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 is focusing on monographs identified as a priority by FDA.

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