Resolutions are a unique aspect of the USP governance process. They provide a formal and institutionalized channel for USP Convention Member Organizations, Delegates, and other interested stakeholders to influence USP’s strategic direction at the beginning of each five-year cycle. They are considered by the Board of Trustees and Council of Experts, reflected in the organization’s policy and operational agendas, and used to adjust and develop new programs.
The 2015–2020 Resolutions were adopted by the USP Convention membership on April 25, 2015.
On behalf of the Board of Trustees, Convention President, and the Council of the Convention, USP is pleased to provide you with a report on the status of the 2015-2020 Resolutions, prepared as a collection of videos.
Collaboration with the U.S. Food and Drug Administration
USP will increase communication and collaboration with the U.S. Food and Drug Administration (FDA) to promote alignment with FDA’s regulatory and scientific policies from the inception of the standards planning and development process. USP will work with FDA, industry, and other stakeholders throughout the process to increase understanding of the regulatory impact of such proposals.
USP–NF Monograph Modernization
USP will meet the needs of U.S. Food and Drug Administration (FDA), industry, and other stakeholders for modern monographs within USP–NF. USP will work to eliminate the existing backlog of monographs in need of modernization and proactively evaluate and update monographs to maintain their relevance given scientific advances and evolving manufacturing and regulatory approaches. USP will work with industry and FDA to explore new strategies for sharing analytical methods and specifications needed to modernize monographs.
Globally Harmonized Standards
USP will expand its commitment to harmonization of compendial standards by working with pharmacopoeias, the World Health Organization, and other stakeholders to determine optimal ways to advance and sustain globally harmonized standards.
USP’s Quality Systems
USP will continue strengthening its quality systems to ensure the timely and accurate delivery of public standards. USP will maintain its commitment to implementing a fully integrated, global approach to quality and will monitor its progress against specified metrics and objectives to achieve continuous improvement as measured by USP performance.
Research and Innovation Within USP
USP will cultivate a collaborative, robust research and innovation culture that will allow USP to continuously assess new technologies and capabilities relevant to its standards-setting activities, and to identify, prioritize, evaluate and develop new opportunities that further USP’s mission and respond to the needs of its stakeholders.
Standards for Biological Medicines
USP will promote alignment with stakeholders to develop quality standards for biological medicines, ensuring that innovation and availability are facilitated and complemented.
Quality Standards for Compounded Medicines
USP will continue working with stakeholders to develop and maintain practice and quality standards for sterile and non-sterile compounding. USP will increase the availability of its compounding standards, expand stakeholder engagement and education, and promote adoption of these standards by compounding professionals and regulatory authorities.
Healthcare Quality Standards
USP will collaborate with stakeholders to develop, strengthen, revise, and promote adoption of healthcare quality standards that address quality and safety related to the use of medications and that are of value to patients and practitioners.
Quality Standards for Dietary Ingredients and Dietary Supplements
USP will expand development of standards for dietary ingredients and dietary supplements, focusing on new and high-impact areas, and engage with stakeholders to promote the awareness and adoption of its standards.
Food Quality and Integrity
USP will continue developing standards to improve the quality and integrity of foods and food components, including those used for vulnerable populations, and identify new products and services to meet the needs of stakeholders and increase USP’s public health impact.
USP’s Global Health Impact
USP will increase its commitment to global public health by advocating for the use of quality standards around the world, enabling access to relevant standards, and working through global partnerships to strengthen systems that ensure access to quality foods and medicine.