Monograph Reform

The system that regulates most OTC medicines, the OTC Monograph System, was established in 1972. Although the system worked well for many decades, over the years it ground to a halt, making it difficult for FDA to update product labels with new safety information based on new science and data while also preventing the development of innovative products to meet consumer needs. On March 27, 2020, Congress included landmark legislation to reform the OTC Monograph system in the COVID-19 response bill, the CARES Act. OTC Monograph reform is a long-sought goal of CHPA, and has had broad stakeholder, FDA, and bipartisan/bicameral support.

CHPA member companies are undertaking an unprecedented effort to collectively help update the U.S. Pharmacopeia’s (USP) 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 is focusing on monographs identified as a priority by FDA.