USP’s activities in North America center around its history and identity as a U.S. standards-setting body, its recognition in U.S. law, and the collaborative relationships it has forged with branches of government and the regional professional and scientific organizations that comprise the majority of the USP Convention membership. USP’s headquarters is located in Rockville, MD, where it serves as a leadership hub for all USP operations—learn more about our headquarters.
Regulatory & Government Agencies
- U.S. Food & Drug Administration (FDA): While USP sets standards, FDA is the U.S. government agency that regulates and enforces USP standards for medicines that are marketed or sold in the country. For more than a century, USP and FDA have collaborated to protect the public health and promote the quality and safety of drugs, dietary supplements, and foods. USP and FDA currently work together in a variety of ways, among them: FDA can request USP standards action, FDA staff act as liaisons to USP Expert Committees, and FDA and USP collaborate through Cooperative Research and Development Agreements (CRADAs). Recent developments include:
- Three-year CRADA signed in May 2011 to further advance collaborative testing efforts related to chemical reference standards, primarily for controlled substances
- Joint efforts to modernize tests and assays in USP’s written standards
- New initiative to further develop test methods for hand-held instruments for screening drugs for adulteration, contamination and authenticity
- Collaborative response to public health crises related to heparin and glycerin
- Support for FDA’s Food Safety initiative
- Health Canada: USP’s relationship with Health Canada stems from its recognition of USP–NF as an official “Schedule B” publication. Health Canada participates on USP Expert Committees and working groups, and it cosponsored USP’s 2009 North American Annual Scientific Meeting in Toronto.
- Other U.S. Government Agencies
- Since Congress signed the Medicare Prescription Drug Improvement and Modernization Act of 2003 into law, USP, per Section 1860D-4(b) (3) (C) (ii) of the Act, has developed and updated Medicare Model Guidelines for the Medicare Prescription Drug Benefit Program. These guidelines list categories and classes of medicines that prescription drug plans may use to develop their own formularies for the Medicare Part D benefit. Version 5.0 was released in March 2011.
- In 2010, USP made an agreement with the U.S. Department of Defense to provide safety and efficacy reviews for selected dietary supplements.
USP continues to reach out to academic institutions and professional and industrial associations whose work is related to the development, manufacture, distribution, and use of pharmaceuticals, dietary supplements, and food ingredients. To this end, USP hosts stakeholder forums, symposia, workshops, and special events and webinars to gather input on timely “Hot Topic” issues.
- Each year, USP holds a Science and Standards Symposium in North America. This event is open to the public and serves as an interactive forum where USP and industry leaders can discuss new direction and standards that affect the pharmaceutical industry. The 2011 symposium was held October 3–6 in Seattle, WA, with a focus on “Biologics & Biotechnology: Advancing Quality Standards through Analytics and Assays.”
- USP addresses timely issues via topical Workshops that encourage discussion on current scientific findings and regulatory trends. Upcoming sessions include
- Pharmacopeial Education courses designed by USP experts are taught in the United States and Canada to provide guidance on interpreting and applying USP standards. View current online and classroom offerings.
- Throughout the year, USP representatives travel across the U.S. and Canada holding USP User Forums—free seminars on timely issues related to USP’s current initiatives. Learn more and register.
Convention & Volunteer Representation
These North American countries have members and/or observers to the U.S. Pharmacopeial Convention, and/or citizens who serve as USP Expert Volunteers. [KEY: M–Members, O–Observers, EV–Expert Volunteers]
- Canada (M, O, EV)
- United States (M, O, EV)