Moving Beyond Borders
While USP standards are recognized in law in the United States, they are used today in more than 130 countries—not only for
compliance with US law in the course of exporting FDA-approved articles to the US, but also for local use and elsewhere. As
such, USP's approach to its work has evolved. The organization has established several international offices and laboratories—first
in Switzerland (2005), followed by full-service laboratory sites in India (2006), China (2007), and Brazil (2008). FDA has
now opened offices in several of these countries, or in nearby ones—and USP collaborates closely with the agency in those
and other nations in which we are operating. More than half of USP's reference material sales (a key indicator of who is utilizing
our standards) now come from overseas—and it is essential to have a presence in areas in which our standards are being used.
In addition to its global sites, USP has forged international agreements with governments, industry associations, and others
around the world. Primarily achieved through a Memoranda of Understanding, USP is now engaging in exciting projects such as
joint standards development with China and India as well as scientific exchange programs. USP has also entered into adopt-adapt
agreements with countries including Kazakhstan and Ukraine that will allow them to use USP's written standards in their own
publications, either by including them entirely as they are published in the USP–NF, in translation ("adopted"), or modified
to better suit the country's requirements ("adapted"). Furthermore, USP has made a concerted effort to include international
experts on its Expert Committees, which are responsible for making scientific and standards-setting decisions for the organization.
Currently, 23 percent are from countries outside the United States. Finally, USP operates several different verification programs—for
finished dietary supplement products, dietary supplement ingredients, and pharmaceutical ingredients (active pharmaceutical
ingredients and excipients)—in which companies enlist our services to verify the quality and consistency of materials. The
rigorous programs, which involve document reviews, GMP audits, extensive laboratory testing, and continued monitoring and
surveillance, are an additional way for companies to ensure the quality of ingredients and products. Participants in these
programs come from around the world.
The Role of Industry
In all of our work, industry plays an essential role—and USP and industry have partnered closely for many years. Where our
collaboration is absolutely critical is in standards development. As we work to modernize our standards—particularly those
we've identified as priorities—we are looking to strengthen our relationship with industry further. We hope to have manufacturer
support through increased submissions of modernization proposals to USP. Further, public review of any modernization proposal
will be another important way we will look to collaborate with industry. All proposals will be included in the Pharmacopeial
Forum (PF), the vehicle in which USP solicits public feedback on its standards. Changes to these standards will potentially
affect the industry significantly, and participation will allow manufacturers to apply their insight in helping to assure
the compendium is based on the latest sound science, and to avoid any unnecessary problems or burdens related to compliance.
To help ensure greater participation in the standards-setting process, USP is transitioning PF to a free resource beginning
Through these activities and many others, USP shares the pharmaceutical industry's goal of contributing to a safe, high-quality
supply of medicines. While today's realities have necessitated changes in our approach, we are eager to meet the challenge,
because our public health motivations are the same as they were in 1820. We believe the initiatives we are pursuing to modernize
our standards will better serve the public, as well as the regulatory community and industry. Industry involvement is critical
for achieving our shared public health goals.
Roger L. Williams, MD, is the chief executive officer of the US Pharmacopeial Convention