Inside USP

US Pharmacopeia's International Activities

Roger L. Williams, MD, is the executive vice-president and CEO of the United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8255. Stefan Shuber, PhD, director of scientific reports at USP, contributed to this column.

Don't be misled by the "US" in the name of the US Pharmacopeia (USP). Since the organization's early days, USP has been actively involved in international affairs. In fact, Congress recognized the US Pharmacopeia in the 1848 Drug Import Act specifically to establish standards to help prevent the import of adulterated drugs. This law was enacted partly in response to reports of soldiers' deaths resulting from adulterated imported drugs during the US–Mexican War (1). Similar concerns about preventing adulteration and protecting and promoting public health and standards prompted passage of the Food and Drugs Act of 1906, the Federal Food, Drug, and Cosmetic Act in 1938 (which made USP standards enforceable by FDA), the Kefauver Amendments of 1962, the Drug Price Competition and Patent Term Restoration (Hatch–Waxman) Amendments of 1984, and the FDA Modernization Act (FDAMA) of 1997. As a result of USP's long history of standards-setting, its compendia and individual monographs, the US Pharmacopeia and National Formulary (USP–NF), are officially recognized by many nations around the world, including Canada. USP collaborates with public health officials and compendia throughout the world. Last December, Canada's Health Products and Food Branch signed a collaborative agreement with USP to take part in the testing and characterization of candidate reference standards. Reference standards are highly purified and well-characterized materials used to test a drug substance or product according to selected procedures of a monograph or General Chapter, thereby establishing the product's identity, strength, quality, and purity. USP and FDA laboratories routinely engage in the collaborative testing of reference standards (2). USP has made reference standards available since the 1960s and currently distributes them to 131 nations (3), where they play an important role in helping ensure the quality of drugs in domestic and international commerce. USP-International A challenge currently facing USP is how best to serve the international community of practitioners and patients while remaining committed to those in the United States. USP is exploring the advisability and feasibility of launching a new official compendium, separate from USP–NF, for articles not marketed in the United States (4). The tentatively titled USP-International (USP-I) could work synergistically with the World Health Organization's International Pharmacopoeia and could include basic and screening procedures to assist customs officials and practitioners in the field. One important effect would be to help reduce the circulation of counterfeit and substandard drugs. USP-I also could help international regulatory bodies because validated analytical procedures and official USP reference standards would be available for drugs included in USP-I. The reference standards also would facilitate international commerce of quality drug products (e.g., by building confidence in their acceptance testing) and help international sponsors who wish to submit an application to FDA for US marketing. Conversely, USP-I could be a powerful tool to help world regulatory bodies identify products that are substandard and that should not be allowed within national borders. Comments on USP-I generally have been supportive (5), and USP will carefully consider all comments as the organization continues to work on USP-I with its Board of Trustees and other constituents. USP's new site in India At USP's Convention 2005 in March, convention delegates approved Resolution 6, which states that "USP resolves to continue working with international governmental and nongovernmental bodies to increase the impact of its public health programs internationally" (6). A month earlier, USP announced plans to open a site in India, including laboratories, business operations, and a broad range of pharmaceutical services for pharmaceutical manufacturers in India and neighboring countries. This will be the first USP laboratory outside the United States, and, as with USP's domestic facilities, it will be certified to relevant ISO standards. The USP India site will support the activities of Indian and regional partners, including the Indian Pharmacopoeia, to promote the manufacture of good-quality therapeutic products globally. USP will work with Indian manufacturers, as it does with US and multinational firms, to supply safe and effective medicines and dietary supplement ingredients and products. The USP India site will involve experienced Indian scientists in the standards-setting activities of USP, with a focus on off-patent medicines that are legally marketed in the United States. In early April 2005, USP hired John Hu, PhD, as vice-president, International–China. Dr. Hu will help establish a USP site in China and will be in charge of that operation once it is in place. He currently is president of the Sino-American Pharmaceutical Professionals Association, a nonprofit organization promoting pharmaceutical sciences and business exchanges between the United States and China. (continued)