Although not part of government, USP standards are recognized in US Law and USP works closely with the U.S. Food and Drug Administration (FDA) as well as leaders in healthcare practice, pharmacy, science, industry, regulatory compliance and consumer protection.
Since 1906, Congress has required that medicines sold in the US be approved by the FDA and meet public standards for quality. Congress recognized the US Pharmacopeia and the National Formulary, or USP-NF, as “official compendia” of those standards.
When Congress created a separate regulatory category for dietary supplements in 1994, it continued to recognize USP-NF standards as official, but made them voluntary. Supplement manufacturers could follow USP’s public standards or create their own private standards. Learn more about standards for dietary supplements here.
As reports of inconsistent quality began to rise, many manufacturers wanted a way to make their investment in quality more visible. So, in 2001 USP created “USP Verified”, a voluntary independent third-party verification program based on USP standards.