Council of the Convention White Papers – Focus On: Future Directions for USP
At its core, the United States Pharmacopeial (USP) Convention is a standards-setting organization with an important national history and gathering recognition around the world. The USP leadership has transformed the organization in remarkable ways in the last decade and will depend on the wisdom and will of its member organizations to help guide it into the future—a future that promises to be equally amazing and challenging.
The Council of the Convention (CoC) offers on this web page several white papers for consideration. The white papers are an excellent source of information about USP for delegates, member organizations, and anyone interested in understanding the nature of the USP Convention and its many activities. The papers describe:
- The current role and value of USP public standards
- Environments in which USP standards are used, or could be used
- Key challenges and opportunities facing the USP Convention as it attempts to realize its vision of a world where all citizens have access to high quality, safe and beneficial medicines and foods.
The CoC and USP welcome your comments on the white papers. Please send comments to CoC@usp.org.
One of the ways members can use these white papers is to stimulate ideas for resolution proposals. Any such proposal will be considered by the Resolutions Committee and, if accepted, will be debated and voted on at the April 2010 Membership Meeting of the USP Convention. Adopted resolutions are considered important guidance for USP through the ensuing five-year cycle and, subject to fiduciary oversight by USP’s Board of Trustees, are reflected in the organization’s policy and operational agendas.
As member organizations and delegates—science and health professionals, manufacturers of medicines, dietary supplements and foods, patients/consumers, and regulators—we are beneficiaries of USP’s standards. There is no question that these standards affect people, processes, and products in ways that improve the health of people around the world. We are called upon to be stewards of USP, by executing our governance responsibilities in an informed and proactive manner and providing direction for the organization’s future. We hope you find the white papers valuable resources and we encourage you to propose a resolution.
USP’s Role In Setting Enforceable Quality Standards For Medicines
In today’s global pharmaceutical market, ensuring the quality and safety of drugs has become an increasing challenge. Recent instances of adulteration have highlighted the potential risks to patients. Would a system that: increases the availability of public standards, promotes compendial harmonization, and uses evolving science to create methods for detecting counterfeit and substandard drugs help to expand the availability of good quality medicines? Download white paper
A Model System To Promote Access To Good Quality Compounded Medicines
Compounding remains an important part of pharmaceutical care and can provide valuable benefits for patients. At the same time, assurance that compounding follows good practices and that manufacturing does not occur under the guise of compounding is critically important. Could there be a model system that builds on good systems in the U.S. and other countries and recognizes the interests of all parties? Download white paper
USP’s Role In Patient Safety
USP’s greatest strength lies in its ability to convene practitioners to set standards they use in daily life. The need for standards that promote safe medication use and quality of care is as strong as ever—and may increase in an era of health care crisis and reform. Would practitioners and other bodies rely on USP’s standards setting “machinery” to create quality of care and related standards? Download white paper
Access To Good Quality Dietary Supplements
While stakeholders debate stronger regulatory oversight of dietary supplements and express unease about broader global sourcing of ingredients and products, are there other measures and mechanisms available to help manufacturers and practitioners protect consumers? Download white paper
Opportunities For Drug Information And Use Standards
USP has ended many of its activities associated with the provision of drug information and use standards; however, there is a larger question that relates to USP’s specific role as a practitioner-based, volunteer-driven, standards-setting organization. In the current environment, what are the societal needs for drug information and use standards to support rational therapeutic decision-making? If these needs can be defined and USP, by virtue of its structure and history, can uniquely fulfill them—with availability of adequate resources—does it have a responsibility to do so? Download white paper
Importance Of Standards In Assuring Good Quality Food Ingredients And Foods
Within the U.S., the ability of regulatory bodies and food manufacturers to provide safe, high quality food to consumers is challenged by the increase in global trade, supply chains that are longer, more complex, and international, and fragmentation of the U.S. food regulatory framework. Does USP have an obligation and the ability to do more to protect U.S. citizens and people around the world from tainted foods and food ingredients? Download white paper
USP’s Role In Assuring Global Access To Quality Medicines
Poor quality medicines can be especially burdensome in developing countries where they not only fail to produce needed results, but also absorb limited resources, undermine faith in already tenuous health systems, and promote antimicrobial resistance to devastating infectious diseases such as HIV, malaria, and tuberculosis. USP can do many things to help improve medicine quality in the world; however, with limited resources, which activities would be of greatest benefit to populations most in need? Download white paper
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