Where in the World is the US Pharmacopeia?

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.
Sep 02, 2011


Susan J. Schniepp
The United States Pharmacopeia (USP) is the oldest continuously revised compendium in the world. Established in 1820, this independent organization has been setting US standards for medicines and pharmaceuticals for more than 185 years. Although FDA recognizes USP standards, the US Pharmacopeial Convention organization was created to be independent from the government, making it the only nongovernmental compendium in the world. The original USP was a collection of recipes to aid pharmacists in formulating medicines for patients. The mission was to produce a book that would allow pharmacists to be able to offer reliable products with consistent names to patients in the United States.

At the time the first USP debuted, the pharmaceutical industry did not exist and pharmacists used the information in USP to deliver uniform products to the approximately 7 million residents residing in the 22 states that comprised the US at that time. The original publication contained monograph instructions for 621 items and was updated at approximately 10-year intervals.

The evolution of USP

Today, USP is updated annually and contains more than 4000 monographs in addition to a myriad of general-test and information chapters. USP has more than 550 full-time employees and uses more than 1000 volunteers to set current compendial standards. In a few short years (9 to be exact) USP will celebrate its 200th birthday. USP has much to be proud of.

However, during the past decade, the organization seems to have decided that the patients and pharmaceutical industry of the US are not a big enough arena for its standard-setting activities. USP has changed its mission statement to indicate that it wishes to "improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods" (1). Its current vision is "...to be a leader in promoting the public health by creating a unique knowledge base—consisting of quality standards and information on proper use—for medicines and related products and practices. USP will ensure that people throughout the world have access to this knowledge base" (1).

USP purchased the Food Chemicals Codex and opened offices in Switzerland, India, China, and Brazil. In its October 2008 mid-cycle convention report, USP indicates that the report is intended to inform "...USP's volunteers—members of the USP Convention; Board of Trustees; Council of Experts, Expert Committees, and Advisory Panels; and Stakeholder Forums and Project Teams—of the strides made to date in the 2005–2010 cycle. It offers a snapshot of significant achievements, milestones, and progress toward the goals articulated at the 2005 USP Convention. And perhaps most importantly, it provides a glimpse of where USP is going in the future..." (1).

In addition, at the USP 2010 Convention, the organization passed Resolution 4, which deals with supporting and advancing global public-health initiatives." The resolution states, "Working in consultation and collaboration with national, regional and global stakeholders, USP resolves to assess the feasibility and advisability of advancing global public health initiatives. Where advisable and feasible, USP should seek to expand its resources for these initiatives, building on identified needs and existing opportunities, in order to support its international activities while preserving and fulfilling its role under US law" (1). On USP's website, there is an update regarding this resolution which indicates that USP is expanding its role in India and China as well as exploring relationships with the Association of Southeast Nations and Middle East and North African nations.