2010–2015 Resolutions

Adopted by the USP Convention membership on April 24, 2010.

April 2012 Status Updates

Resolution 1

Grandfather Constitutionally-Named Organizations
USP resolves that all organizations that were named in the USP Constitution prior to the adoption of the Amended and Restated Bylaws shall automatically become Voting Organizational Members of the Convention under the new Bylaws. These organizations shall continue to be members until they resign or are removed for cause in accordance with the Amended and Restated Bylaws. Status

  • In October 2010, The Council of the Convention recommended to the Board of Trustees that all organizations named as members in the USP Constitution prior to the adoption of the Amended and Restated Bylaws be invited as members to the Convention, in order to fulfill the intent of this resolution. The Board approved this recommendation, and USP notified all grandfathered organizations in November 2010 of their continuing member status in the USP Convention. The letter also explained that appointment/reappointment of a delegate by November 2011 was required for continued membership, as provided in the Bylaws.
  • On February 27, 2012, 61 Voting Organizational Members were removed for cause from the USP Convention because they had not appointed/reappointed their delegates within the required timeframe. As of April 25, 2012 member appointment is at 97%—total membership is 434, and there are 11 recently-invited member organizations that have not yet appointed delegates.

Resolution 2

Strengthen Focus on Core Compendial Activities
USP resolves to strengthen its focus on core compendial activities, working collaboratively with academia, industry, regulators and other stakeholders, and utilizing a robust quality management system within USP and its Council of Experts, to ensure relevant, timely and accurate public standards. Status

  • USP has instituted a comprehensive review of its compendial processes, and has initiated several major changes using the results of the various assessments of the United States Pharmacopeia-National Formulary (USP–NF) redesign and recall as well as a staff-driven Compendial Transformation Team.
  • Redesigned monographs are being introduced in a more methodical, phased way to ensure that there is sufficient time to produce high-quality standards when USP–NF is published. This initiative will require a number of years to complete, especially for the small molecule drug monographs in the USP, which represent the bulk of USP–NF monographs.
  • USP has increased the involvement of its Quality Assurance (QA) group in its documentary standards activities to help ensure conformance to processes. Redesigned monographs are now receiving explicit QA reviews by a dedicated, trained team of QA experts on staff, separate from quality control reviews within the department that is responsible for the standards.
  • USP is continuing to increase opportunities for stakeholder involvement in its standards-setting activities by holding additional workshops and webinars, expanding participation in its Expert Panels, and providing frequent updates to stakeholders on key standards through its website and compendial notices service. For high impact standards, USP is utilizing a “design phase” approach where input from industry, regulators, and other key stakeholders is solicited prior to development of a proposed standard.
  • USP continues to explore ways to gain timely information and candidate materials to support its public standards. Further, USP is working on other approaches that allow USP to develop documentary and reference material standards for foods and drugs independent of a donor.
  • The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research has encouraged USP to update its monographs and provided USP with a list of high-priority monographs for updating. FDA has formed a monograph modernization task group to work with USP on this activity. This action is in accordance with stipulations in the U.S. Food, Drug, and Cosmetic Act that call on the Secretary (delegated to FDA) to inform USP when its standards in USP–NF are deficient. USP has responded enthusiastically to this encouragement, and is working diligently on the high priority monographs as well as collaborating with FDA on general approaches to monograph modernization.
  • USP has analyzed all of its existing monographs in the USP–NF and now is able to accurately quantify all of those that need to be updated. USP is continuing to evolve its methodology for prioritizing these monographs, and is using its own laboratory capabilities to work on modernized tests and procedures in addition to soliciting modernization proposals from industry donors.
  • USP General Chapters are undergoing systematic reviews and updates, and new chapters are being developed, as needed, to assure that the technologies and processes presented are consistent with those currently used across the pharmaceutical industry.
  • The Reference Materials Division and Documentary Standards Division have been combined to form the Science and Standards Division. This further integrates and streamlines the documentary and physical standards processes and further integrates the Quality Assurance unit into these processes.

Resolution 3

Strengthen USP's Relationship with the U.S. Food and Drug Administration
USP resolves to strengthen its relationship with the Food and Drug Administration (FDA), and work with FDA and other public and private stakeholders to explore mechanisms to enable USP to provide and maintain up-to-date national standards for legally marketed drugs and excipients in the United States. Status

  • USP’s President, Chairman of the Board of Trustees, CEO, and Chief Documentary Standards and Legal Officer met in early 2011 with the Director of FDA’s Center for Drug Evaluation and Research and her staff. The group discussed ways to strengthen relationships with greater cooperation on identifying, producing, and/or revising priority standards on which USP should focus.
  • FDA continues to be actively involved in USP standards-setting activities, with over 103 liaisons currently participating in USP Expert Committees and Expert Panels.
  • Through other formal and informal means, USP and FDA officials have elevated information sharing about issues including monograph modernization and compounded medicines standards. As noted above, FDA has formed a monograph modernization task group which provides input to USP on priorities for modernization, and USP meets regularly with the task group.
  • Special emphasis is being placed on the modernization of monographs for over the counter drug products marketed under the FDA monograph system. Collaboration is also occurring in a number of general chapter areas.
  • FDA and USP signed a 2011 Cooperative Research and Development Agreement (CRADA) that supports development of USP written and physical reference standards for the quality, identity, purity, and strength of medicines. Provisions call for: collaborative testing between USP and FDA laboratories of roughly 40 chemical reference standards each year of the agreement, primarily of controlled substances; modernization of tests and assays in USP’s written or documentary standards where needed; and developing test methods for hand-held devices that FDA inspectors can use to screen drugs in the field for adulteration or contamination. This agreement substantially expands upon a previous agreement.
  • USP is cooperating with FDA on a Substance Registration System CRADA which has been extended for four additional years to provide support for health information technology initiatives by establishing a Unique Ingredient Identifier (UNII) for substances in drugs, biologics, botanicals. Food and devices based on molecular structure and/or identifying descriptive information. The UNII has been incorporated into the FDA’s Structured Product Labeling and USP's USP Dictionary of USAN and International Drug Names and has the potential to support a number of Health Information Technology Initiatives including electronic prescribing. The UNII is also fundamental to the generation of other medication terminology including the National Library of Medicine RxNorm and is currently being considered as an International Standards Organization (ISO) standard.
  • USP is collaborating with FDA on several patient safety related projects including: establishment of a clear and recognized definition for single-dose/single-use vials, and establishing a clear understanding of how practitioners recognize the salt content and placement on the drug product label. USP has undertaken two market research projects on these issues.

Resolution 4

Support and Advance Global Public Health Initiatives
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 U.S. law. Status

  • Following Board of Trustees’ approval, USP expanded its presence in India dramatically by building a replacement site in Hyderabad that will house well over 100 staff. The new site expands laboratory capabilities for USP.
  • USP launched the Medicines Compendium (MC) in 2011 as a free, online compendium comprising quality standards for medicines moving in global commerce. The scope of medicines eligible for inclusion in the MC will be those approved for marketing by any national authority. As such, it will be devoted primarily to non-U.S. manufacturers who wish to demonstrate that they are conforming to standards established by one or more dedicated Expert Committees of the USP Council of Experts; a 21st Expert Committee was established in India to assess and approve MC standards. The MC continues to expand, with the formation of a 22nd Expert Committee in China to evaluate and approve MC standards.
  • USP explored expansion of its China site in 2011, with a potential added focus on food ingredient quality. The Board approved the expanded site, which is now under construction and expected to open mid-2013. The site will be approximately 80,000 square feet, including 40,000 square feet of new laboratory space.
  • USP conducts science and standards meetings around the globe. In 2011 such meetings included a USP-Chinese Pharmacopeia Commission meeting with more than 600 attendees (with representatives from the world’s leading pharmacopeial bodies), a meeting with the Association of Southeast Asian Nations (ASEAN), and meetings in South Asia (India), and Middle East and North Africa (Egypt, Jordan, and Turkey).
  • In 2011, USP launched a Technical Assistance Program (TAP) in Sub-Saharan Africa in support of official medicines control laboratories in five countries. The participating countries will receive a comprehensive package of pharmaceutical reference standards (pure physical reference chemicals for testing), documentary standards (written specifications), and technical training from USP at no or dramatically reduced cost. The TAP formalizes and expands upon previous contributions and subsidies USP has made around the world.
  • USP continues to carry out its expanded work with the U.S. Agency for International Development (USAID)-funded Promoting the Quality of Medicines (PQM) program. USP is registered in Ethiopia to facilitate growing work there and launched a publicly available Medicines Quality Database, which will help health authorities, manufacturers, and regulators identify poor quality medicines.
  • Overall, USP operates actively in eight regions of the world and works to build links to key practitioner, trade, academic, ministerial, and other stakeholder bodies. Many of these bodies conform to their counterparts in the U.S., and it is from these linkages that member candidates arise for consideration by the Council of the Convention.
  • In 2012, the USP Board of Trustee endorsed the creation of a new USP-Sub-Saharan Africa Center for Pharmaceutical Advancement and Training (CePAT). It is anticipated that CePAT will be located in Accra, Ghana to serve sub-Sahara Africa as an integrated platform for training, education, consulting and laboratory capabilities, offering a systematic approach to assist with the quality control of medicines in sub-Saharan Africa.

Resolution 5

Strengthen and Expand Harmonization Efforts
USP resolves to strengthen and expand its efforts to work with pharmacopeias, industry, academia, regulators, international organizations and other stakeholders around the world to develop harmonized global standards. Status

  • Although the International Conference on Harmonisation (ICH) decided in November 2010 to end formal connections with the Pharmacopeial Discussion Group (PDG), USP and its counterparts in Japan and Europe remain committed to PDG. PDG met in June 2011 to consider ways to improve and strengthen PDG collaboration, focusing on excipient standards. Meetings continue to occur twice a year, and are now hosted by each of the participating pharmacopeias (USP, EP, JP) on a rotating basis. The next meeting is in Tokyo, Japan, in June 2012.
  • USP has been working with staff of the European Pharmacopoeia Commission (EP) on a prospective harmonization pilot in which the pharmacopeias are developing monographs and reference standards for four drug substances with the goal of harmonizing these standards at the outset. These staff and the participating companies met in June 2011 to evaluate the pilot. USP and staff of the British Pharmacopoeia Commission (BP) also have been exchanging information on two drug product monographs in development simultaneously at BP and USP, and believe that such communications may help achieve greater harmonization between the final monographs. USP and EP have continued their prospective harmonization pilot into 2012 to determine the feasibility of maintaining harmonization of the four drug substance monographs included in the pilot as generic products enter the US and European markets.
  • In 2011, USP entered into “adopt/adapt” agreements with pharmacopeias in several regions, including Ukraine and Kazakhstan. The agreements allow these pharmacopeias to freely incorporate USP–NF standards into their own compendia.
  • USP’s new Medicines Compendium (See Resolution 4 status report) is an experimental step by USP to strengthen and expand efforts to work with organizations around the world to develop a single global standard. Similarly, the variety of science and standards symposia and joint agreements USP has entered into and the international visiting scientists it has sponsored since the April 2010 Convention increase the exchange of information key to harmonizing the quality standards-related work of pharmacopeias and regulatory authorities.
  • USP is assisting the ASEAN Reference Standards Working Group with its efforts to provide certified reference materials (CRMs). ASEAN comprises representatives from medicines control laboratories in the ten participating Member States of ASEAN. These ASEAN CRMs would promote harmonization within that region.
  • USP and the Chinese Pharmacopoeial Commission (ChP) co-hosted the first Global Summit of the Pharmacopeias in Beijing, China from November 17–18, 2011. Representatives from 16 pharmacopoeias (including WHO’s International Pharmacopoeia) and one regulatory authority attended this historic event. The Summit began with a general introduction of each country or region’s pharmacopeia and drug regulations. Participants of the Summit then engaged in a discussion of issues and opportunities including international pharmacopeial harmonization; strengthening collaboration among pharmacopeias; and establishing information sharing mechanisms. At the end of the Summit, a majority of the participants reached an agreement to continue pursuing global pharmacopeial collaboration to assure public health via the promotion of public quality standards.
  • USP participated in the World Health Organization's "International Meeting of the World's Pharmacopoeias" held February 28, 29, and March 1, 2012 in Geneva, Switzerland. Dr. Duane M. Kirking, Chairman of the USP Board of Trustees, attended the meeting along with Dr. Roger Williams and Ms. Angela Long. Over 20 pharmacopeias were present. The first day was devoted to the presentations of the pharmacopoeias, based on questions provided by WHO. The participating pharmacopoeias also outlined their strategies for the future and particularly emphasized the need for harmonization among pharmacopoeias. The group agreed that new platforms for the pharmacopoeial harmonization should be identified and should be open to all pharmacopoeias wishing to participate. The primary outcome was the idea to develop "Good Pharmacopoeial Practices" which would focus on prospective harmonization.

Resolution 6

Continue and Expand Commitment to Quality Standards for Food Ingredients
Working in consultation and collaboration with academia, industry, regulators, and other stakeholders, USP resolves to continue and expand its commitment to quality standards for food ingredients, working to strengthen the role of Food Chemicals Codex (FCC) as a global compendium for food ingredients, increasing the number of documentary standards and reference materials based on identified needs, and exploring the feasibility and advisability of expanding the scope of FCC. Status

  • USP has petitioned the FDA to update its references to FCC standards in the Code of Federal Regulations to ensure that the most recent versions of these standards are in effect.
  • USP has reached out to FDA’s Center for Food Safety and Nutrition to ensure that the agency is fully aware of USP’s activities and potential assistance as the agency moves to implement the Food Safety Modernization Act, which USP supported.
  • USP is advancing international cooperative efforts in its foods standards-setting areas. As an example, USP has begun Memorandum of Understanding (MOU) work with China’s National Center for Food Safety Risk Assessment (formerly the National Institute for Nutrition and Food Safety), which is part of the Chinese Ministry of Health’s Centers for Disease Control in Beijing. Translation of USP’s FCC is proceeding under the MOU.
  • In a 2011 meeting in Beijing, USP senior leadership clarified opportunities that might allow improved linkages between specifications for food additives/ingredients as they appear in Codex Alimentarius monographs, the corresponding “GB” standards in China, and FCC. Opportunities for expanding USP’s food ingredient documentary standards and reference materials are being evaluated, and potential expansion of activities at an expanded USP China site is being explored.
  • USP has developed a database to provide information that can be useful in evaluating current and emerging risks for food fraud. The new database (www.foodfraud.org) provides baseline information to assist interested parties in assessing the risks of specific products. It includes a total of 1,305 records for food fraud based on a total of 660 scholarly, media and other publicly available reports. Records are divided by scholarly research (1,054 records) and media reports (251 records).
  • The Executive Committee of Codex Alimentarius voted favorably on USP’s petition for Observer Status. It is expected that the plenary session will follow this recommendation and finalize USP’s status as an officially recognized NGO to Codex Alimentarius.
  • USP held a successful workshop on adulteration of food and dietary supplements that received considerable interest abroad; in-country follow-up workshops have been requested by regulatory authorities from Chile, China and Israel. Other high-profile activities include a workshop on probiotics and the Standard and Science Symposium on Functional Foods and Dietary Supplements.
  • Since the Convention in 2010, 40 new monographs have been published, 2 new Appendices added and numerous monographs and appendices have been modernized and revised. USP published the Food Chemicals Codex (FCC) in its Eighth Edition in March 2012. In the same period, USP released 33 new reference materials (F-lots) for use in FCC monographs.

Resolution 7

Promote Availability, Use and Recognition of Quality Standards for Dietary Supplements
Working in consultation and collaboration with academia, industry, regulators, and other stakeholders, USP resolves to continue its commitment to provide quality standards for dietary supplements, including strengthening the role of USP standards for dietary supplements products and ingredients and promoting the use and awareness of such standards. Status

  • The second edition of the Dietary Supplements Compendium will ship in April 2012. The new edition contains full, redesigned versions of the current dietary supplement monographs, 50 new monographs for dietary supplements, a section from the National Formulary dedicated to excipients in use for dietary supplements, and expanded color plates and a photographic section with 11 new plant materials.
  • USP is working in China and India to build better links between monographs and reference materials for dietary supplements, which frequently correspond to natural products in these countries—traditional Chinese medicines (TCM) in China or Ayurvedic medicines in India.
  • New Expert Panels established in India and China have produced 34 new dietary supplement monographs. In an effort to provide worldwide standards for natural products, USP has launched work on a new Traditional Medicines Compendium as a home for natural health products legally marketed outside the US. The panels in India and China will assist with this effort and report to the Dietary Supplements Expert Committee.
  • In early 2012, USP concluded the first of three reports for the Uniformed Services University of Health Sciences. Benefits and Safety of Beta-Alanine for Military Personnel reports the findings of a research project conducted under the aegis of the Dietary Supplements Expert Committee by an Expert Panel established specifically for this work.

Resolution 8

Develop, Maintain and Promote Adoption of Quality Standards for Compounded Medicines
USP resolves to continue its commitment to standards for compounding, working with the compounding community, regulatory authorities and other stakeholders to develop and maintain optimal process and preparation standards, and promote adoption of such standards by compounding professionals and regulatory authorities. Status

  • USP has begun a vigorous exchange of information and views with the FDA regarding compounded medicines standards. USP is seeking greater clarity on the best approach for developing and producing compounding-related standards in the future. USP and FDA are collaborating on a study to test compounded preparations using USP monograph methods as a way of determining regulatory suitability of the monographs.
  • In 2011, USP evaluated the feasibility and advisability of publishing a future edition of its Pharmacists’ Pharmacopeia or similar publication that could serve as a resource for practitioners.
  • As a result of its evaluation in 2011, USP has developed a new online (PDF) product, USP on Compounding, which will replace the Pharmacists’ Pharmacopeia. This new product will contain all general chapters related to compounding plus more than 50 referenced chapters and general notices. This product will be sold in the USP iStore and distributed through various pharmacy organizations such as IACP, NCPA, and APhA. A Compounding Compendium will be considered as soon as the compounding monographs have been redesigned, modernized, and new monographs developed.
  • USP continues to support the Pharmacy Compounding Accreditation Board (PCAB), which is a site accrediting activity, led by the American Pharmacists Association and other key pharmacy practitioner bodies. USP sits on the PCAB governing board and plays an active role as vice-chair of the PCAB Accreditation Committee.
  • USP has contracted with university and commercial labs to perform method development and stability studies to support the development of new compounding monographs.
  • After four years in circulation as an official standard, General Chapter <797> is being revised in an effort to reorganize and clearly define sterile compounding. The Expert Committee also will undertake two new general chapters: Compounding for Investigational Studies and Compounding with Hazardous Drugs.

Resolution 9

Explore Development of Quality Standards of Value to Practitioners and the Public
USP resolves to explore the feasibility and advisability of assisting practitioner groups and other stakeholders to develop quality standards of value to practitioners and the public. Status

  • USP released General Chapter <17> Prescription Container Labeling, a standard that optimizes label content to help ensure patient compliance and medication use safety. *This Chapter will be published in USP 36–NF 31 and become official in May, 2013.
  • USP hosted a Consumer-Patient Summit in April 2011 to better understand health-related challenges facing consumer stakeholders and where USP standards for drugs and dietary supplements could help. USP will assess options for greater or different assistance to these stakeholders.
  • In 2011, USP formed a Monograph Naming Advisory Group to develop a plan for educating practitioners about the implications of USP’s new monograph naming policy and the changes they can expect to see in the way medicines are named.
  • The Monograph Naming Advisory Group now plans to conduct outreach specifically to FDA reviewers, USP scientific liaisons, and industry beginning in late Spring 2012. The policy becomes official in May, 2013.
  • USP leadership conducted intensive outreach visits to key pharmacy associations and colleges and schools of pharmacy in 2011, including the annual meeting of the American Pharmacists Association in Seattle. USP’s CEO visited several schools of pharmacy during 2011.
  • USP launched the Academic Pharmacy Resource Program, through which schools of pharmacy can obtain access to the USP–NF on-line at no charge, and can also obtain USP reference standards at a reduced charge.
  • USP is collaborating with pharmacy organizations to offer courses on USP’s compounding general chapters that will provide continuing education credit.