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OTC Monograph System Reform

OTC Monograph System 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.

OTC medicines are the trusted first line of treatment for millions of consumers.


Who We Are

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering self-care by preserving and expanding choice and availability of consumer healthcare products.

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