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.
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Modern Regulation for Today's Marketplace
Recognizing the dire need for reform, FDA, public health stakeholders, and industry came together to drive historic change. As a champion and vocal advocate for OTC Monograph reform, the Consumer Healthcare Products Association (CHPA) strongly supported the bipartisan legislation — the Over-the-Counter Monograph Safety, Innovation, and Reform Act — that overhauled the system and will affect Americans for generations to come.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details. Federal Register notices are for general information purposes only and should not be relied upon as a substitute for thorough regulatory assessment. All efforts are made to assure the accuracy and completeness of this information, but CHPA cannot guarantee the information. As a benefit of CHPA membership, recipients are asked not to forward or share this information outside of your company.
The Senate HELP Committee made a strong bipartisan move to modernize the regulatory system overseeing most OTC medicines by approving S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act by voice vote.
CHPA issued the following statement today following the introduction of S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, sponsored by Senators Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.).