Adopted by the USP Convention membership on April 24, 2010.
January 2013 Status Updates
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
- 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 (from among the Constitutionally-Named Organizations) were removed for cause from the USP Convention because they had not appointed/reappointed their delegates within the required timeframe. As of January 21, 2013 member appointment is at 99%—total membership is 441, and there are 5 recently-invited member organizations that have not yet appointed delegates.
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 instituted a comprehensive review of its compendial processes, and 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. With the global consolidation of the science and standards division under one leadership position, a further review is occurring to optimize USP’s global resources, minimize redundancy, and focus on core compendia activities.
- Redesigned monographs are being introduced in a methodical, phased way to ensure that there is sufficient time to produce high-quality standards when USP–NF is published. This initiative is complete for excipients and dietary supplements, but will require a number of years to complete for the small molecule drug monographs in the USP, which represent the bulk of USP–NF monographs.
- USP increased the involvement of its Quality Assurance (QA) group in its documentary standards activities to help ensure conformance to processes. New monographs, accelerated and regular revisions are sampled. All redesigned monographs receive explicit QA reviews by a dedicated, trained team of QA experts on staff, separate from the quality control review team within the department that is responsible for the standards. In 2013, QA plans to expand the QA review process for Food Chemicals Codex. QA also plans to establish a QA review process for the Medicines Compendium
- USP increased 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 utilizes a “design phase” approach where input from industry, regulators, and other key stakeholders is solicited prior to development of a proposed standard. In addition to continuing regular meetings of stakeholder forums, USP also engaged directly with key industry associations to enhance communication and collaboration.
- USP continues to explore ways to gain timely information and candidate materials to support its public standards. Further, USP worked to build approaches that allow USP to develop documentary and reference material standards for foods and drugs independent of a donor. These approaches were utilized to develop standards in USP’s Medicines Compendium and to facilitate modernization of monographs in USP–NF.
- The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research encouraged USP to update its monographs and provided USP with a list of high-priority monographs for updating. FDA 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 responded enthusiastically to this encouragement, and is working diligently on the high priority monographs and collaborating with FDA on general approaches to monograph modernization, as noted under Resolution 3 below.
- USP analyzed all of its existing monographs in the USP–NF and was able to accurately quantify all of those that need to be updated. USP continues to evolve its methodology for prioritizing these monographs. The organization uses its own global laboratory capabilities to work on modernized tests and procedures in addition to soliciting modernization proposals from industry donors.
- USP General Chapters undergo systematic reviews and updates, and new chapters are 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 were combined to form the Global Science and Standards Division. This action further integrated and streamlined the documentary and physical standards processes and further integrated the Quality Assurance (QA) unit into these processes. Key QA initiatives have included: piloting a new Reference Standards evaluation process; instituting a formalized investigation process for customer complaints, and establishing a Customer Experience Cross-Functional Group with the goal of improving interactions with its customers and providing USP with ways to continually improve its products and processes.
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 (CDER) 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 110 liaisons currently participating in USP Expert Committees and Expert Panels. FDA representatives also participate actively in USP’s scientific workshops and conferences.
- Since June 2012, an FDA representative has participated as part of the USP delegation to the Pharmacopeial Discussion Group to provide FDA’s perspective on harmonization activities with the European and Japanese Pharmacopoeias.
- USP management meets quarterly with the Office of Pharmaceutical Science within CDER to share information on topics of mutual interest and coordinate collaborations between USP and FDA.
- As noted above, FDA formed a monograph modernization task group which provides input to USP on priorities for modernization. USP staff involved in modernization meet regularly with the leadership of the task group to agree upon prioritization of monographs, provide updates on the progress of work, and explore avenues for accelerating modernization efforts.
- USP placed special emphasis on the modernization of monographs for over the counter drug products marketed under the FDA monograph system, and works to obtain FDA’s input on new approaches for modernization of these products.
- Collaboration between USP and FDA occurs in a number of general chapter areas, with ongoing communication to help ensure consensus on new and updated chapters and facilitate implementation by industry.
- FDA and USP signed a Cooperative Research and Development Agreement (CRADA) in 2011 that supports development of USP written and physical reference standards for the quality, identity, purity, and strength of medicines. Provisions call for: collaborative testing by FDA laboratories of USP reference standards, primarily 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. Pursuant to this CRADA, USP and FDA labs are working together to develop methods to support monograph modernization.
- USP and FDA also signed a Substance Registration System CRADA, (which extended through September 2014) 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 the 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 being considered as an International Standards Organization (ISO) standard.
- USP collaborated with FDA on several patient safety-related projects. The first involved establishing a clear and recognized definition for single–dose/single-use vials, and the second was to obtain a clear understanding of how practitioners recognize salt content of a drug and placement on the drug product label. USP has undertaken two market research projects on these issues.
- USP met with staff in FDA’s Office of Global Regulatory Operations and Policy to explore ways USP and FDA could work together in the world. Areas of collaboration suggested by USP included: leveraging USP’s existing work with health ministries, regulatory authorities and pharmacopoeias, participating in USP meetings and interactions with regulators and industry stakeholders in USP’s eight global regions; participating in USP’s Medicines Compendium Expert Committees; and utilizing USP’s international site laboratory capabilities for FDA purposes and/or to address emergency or public health needs.
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 currently houses nearly 135 staff with the ability to add more. The new site, which was inaugurated in 2011, expanded laboratory capabilities for USP. USP owns property adjacent to the site, which can be used for further expansion and new initiatives.
- 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 are those approved for marketing by any national authority. As such, the MC is devoted primarily to non-U.S. manufacturers who wish to demonstrate that they conform to standards established by one or more dedicated Expert Committees of the USP Council of Experts; an Expert Committee was established in India to assess and approve MC standards.
- USP expanded the MC by establishing: an Expert Committee in China to evaluate and approve MC standards for excipients (April 2012); an Expert Committee in Latin America to evaluate and approve MC standards for chemical medicines; and a third MC Expert Committee on biologics (January 2013).
- The Board approved an expanded site in China, 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 in six global regions: North America; Latin America (in Brazil and Mexico); South Asia (in India); East Asia (in China and with the Association of Southeast Asian Nations); Middle-East/North Africa (in Turkey and Jordan); and East Europe/Newly Independent States (in Russia).
- In 2011, USP launched a Technical Assistance Program (TAP) in Sub-Saharan Africa in support of official medicines control laboratories in five countries. Today, USP operates TAP in approximately twenty countries in Latin America, Sub-Saharan Africa, and South East Asia. The participating countries 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. TAP formalized and expanded upon previous contributions and subsidies USP had 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 registered in Ethiopia to facilitate growing work there and launched a publically available Medicines Quality Database, which helps health authorities, manufacturers, and regulators identify poor quality medicines.
- In 2012, the USP Board of Trustee endorsed the creation of a new USP-Sub-Saharan Africa Center for Pharmaceutical Advancement and Training (CePAT). 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. USP hopes to inaugurate the center in May 2013. A technical advisory group was formed comprising representatives from University of Ghana, regulatory authorities in Sub-Saharan Africa and other international organizations involved in global public health.
- Overall, USP operates actively in all 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.
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 remained committed to PDG. PDG routinely considers ways to improve and strengthen PDG collaboration, focusing on excipient standards and broad-based general chapters. At present, 28 of 35 General Chapters and 43 of 62 excipient monographs in the current work program have been harmonized. USP actively participates in PDG by attending meetings twice a year, which are hosted on a rotating basis by each of the participating pharmacopeias (USP, EP, JP). The next meeting is in Strasbourg, France in June 2013. PDG also meets monthly by teleconference between in-person meetings. As noted in Resolution 3, an FDA representative now participates in PDG meetings as part of USP’s delegation.
- USP worked with staff of the European Pharmacopoeia Commission on a prospective harmonization pilot. During the pilot, the pharmacopeias developed monographs and reference standards for four drug substances with the goal of harmonizing standards at the outset. This pilot was continued to determine the feasibility of maintaining harmonization of the four drug substance monographs as generic products enter the US and European markets.
- In a similar project, USP and staff of the British Pharmacopoeia Commission (BP) exchanged information on two drug product monographs, which were in development simultaneously at BP and USP. Such communications may help achieve greater harmonization between the final monographs.
- 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 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, efforts such as USP’s science and standards symposia, joint agreements, and the international visiting scientists USP has sponsored since the April 2010 Convention increase the exchange of information that is key to harmonizing the quality standards-related work of pharmacopeias and regulatory authorities.
- USP assists the Association of Southeast Asian Nations (ASEAN) Reference Standards Working Group with its certified reference materials (CRMs) by helping to procure candidate bulk substances and producing the first CRM. ASEAN comprises representatives from medicines control laboratories in the ten participating Member States of ASEAN. ASEAN CRMs help to promote harmonization within that region.
- USP and the Chinese Pharmacopoeial Commission (ChP) co-hosted two Global Summits of the Pharmacopeias in China (Beijing in November 2011 and Xi’an in September 2012). Representatives from 16 pharmacopoeias (including WHO’s International Pharmacopoeia) attended the first meeting and 11 pharmacopoeias were present for the second Summit. Participants discussed issues and opportunities including international pharmacopeial harmonization; strengthening collaboration among pharmacopoeias; and establishing information sharing mechanisms. As a result of the first two summits, the Chinese Pharmacopoeia is creating a database containing pharmacopoeial methods currently in use by seven of the pharmacopoeias. A third Summit is planned for September 2013 in the U.S. in Baltimore, MD.
- USP also participated at the Senior Management and Board level in two World Health Organization International Meeting of the World's Pharmacopoeias; one in February 2012 in Geneva, Switzerland and a follow-up meeting in Amsterdam, The Netherlands in October 2012. At the first meeting, pharmacopoeias agreed that new platforms for 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. During the follow-up meeting in October there were recommendations to consider performance based monographs and formation of a Global Pharmacopoeia Group as a more-inclusive alternative to PDG. The next WHO co-sponsored event is set for April 2013 in Delhi, India with the Indian Pharmacopoeia Commission (IPC) as co-sponsor. USP offered its assistance and co-located the USP–IPC Science and Standards Symposium with the IPC–WHO event.
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
- Since the Convention in 2010, 54 new monographs and 3 new Appendices have been added, among them one on probiotics, which expanded the scope of the Food Chemicals Codex to this important food ingredient. Another 14 monographs and 5 Appendices were modernized and others revised. At this update, 19 new and 10 modernized monographs and 2 Appendices are pending public review and comment. USP published the FCC in its Eighth Edition in March 2012. In the same period, USP released 49 new reference materials (F-lots) for use in FCC monographs and incorporated 60 existing reference materials for new testing uses.
- USP 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 reached out to FDA’s Center for Food Safety and Nutrition, its Office for International Programs and Policy, and its Office for Food Additive Safety to ensure that the agency was fully aware of USP’s activities and potential assistance as FDA moves to implement the Food Safety Modernization Act, which USP supported.
- USP supports the USDA Agricultural Marketing Service’s efforts to require in their Commercial Item Descriptions (CIDs), which lay out the specifications for government procurement, compliance with FCC and USP–NF specifications for all food additives by reviewing the CIDs and providing written comments/advice.
- To complement its standards-setting activities and aid in promoting food safety, in 2012, USP developed a database that provides information that can be useful in evaluating current and emerging risks through the fraudulent adulteration of food. The database provides baseline information to assist in assessing the risks to specific products. It includes a total of 2,000 records (up from its original 1,305 records) for food fraud based on a total of 1000 (previously 660) scholarly, media and other publicly available reports. The database attracts considerable interest from all external stakeholders (media, regulators, and industry).
- USP advanced several international cooperative efforts in its foods standards-setting areas. For example, early in the cycle, USP signed a Memorandum of Understanding (MOU) pertaining to work with China’s National Center for Food Safety Risk Assessment (CFSA) (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. In a 2011 meeting in Beijing with MOU partners, 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. Translation of USP’s FCC under the MOU is almost complete and printing is expected to begin shortly. USP and CFSA held a workshop in Beijing in 2012 that covered USP’s initiatives to strengthen identity standards for food ingredients, explored CFSA’s needs, and identified areas for further collaboration. Opportunities for expanding USP’s food ingredient documentary standards and reference materials are being evaluated, and potential expansion of activities at USP’s expanded China site is being explored.
- USP was granted Observer Status in Codex Alimentarius in 2012 and is now an officially recognized NGO to this international body. This status allows USP to fully and independently represent its interest at all relevant Codex meetings.
- In November 2011, USP held a successful workshop on adulteration of food and dietary supplements that received considerable interest abroad. In-country follow-up workshops were held in 2012 by the request of regulatory authorities in Chile and China. A similar workshop is scheduled for March 2013 in Israel. Other high-profile activities included visits to regulators and several academic institutions in Brazil, a workshop on probiotics, and the Standards & Science Symposium on Functional Foods and Dietary Supplements in 2012.
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 was published 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 works 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.
- Expert Panels established in India and China produced 34 new dietary supplement monographs. In an effort to provide worldwide standards for natural products, USP launched work on a new Herbal Medicines Compendium as a home for natural health products legally marketed outside the US. The panels in India and China 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. Another Expert Panel finished the evaluation of Arginine and the second report will be released in February 2013.
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
- In 2012, USP began a vigorous exchange of information and views with the FDA regarding compounded medicines standards. USP sought greater clarity on the best approach for developing and producing compounding-related standards. USP and FDA collaborated on a study to test compounded preparations using USP monograph methods as a way of determining regulatory suitability of the monographs. All preparation monographs tested by the FDA laboratories passed the methodology and stability procedures with few adjustments needed.
- USP contracted with university and commercial labs to perform method development and stability studies to support the development of compounding preparation monographs. A total of 27 new compounded preparation monographs will become official in 2013. Several others are in various stages of development, public comment, and approval.
- 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 this evaluation, USP developed an online (PDF) product, USP on Compounding: A Guide for the Compounding Practitioner, which replaced the Pharmacists’ Pharmacopeia. The PDF product contains all general chapters related to compounding plus more than 40 referenced chapters and General Notices. USP on Compounding is sold in the USP iStore and distributed and sold through various pharmacy organizations such as the International Academy of Compounding Pharmacists (IACP) and National Community Pharmacists Association (NCPA).
- 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.
- In 2010, after several years in circulation as an official standard, the Compounding Expert Committee began a revision of General Chapter <797> Pharmaceutical Compounding—Sterile Preparations to clearly define sterile compounding and make the chapter more user-friendly. To assist the Expert Committee in this work, an Expert Panel will be formed in early 2013, and USP plans to work closely with FDA and Centers for Disease Control and Prevention on the effort. The Expert Committee plans to develop two new general chapters: Compounding for Investigational Studies and Compounding with Hazardous Drugs.
- Sterile compounding came under scrutiny in 2012 due to more than 35 deaths reported across the US from an apparent contamination of a compounded steroid preparation prepared by a compounding pharmacy in New England. USP staff were interviewed by numerous media outlets and participated in discussions with congressional staff regarding General Chapter <797> Pharmaceutical Compounding —Sterile Preparations. These interviews were positive in nature and emphasized the important role of <797> in helping to ensure the safety and quality of sterile compounded preparations. USP also provided additional compounding resources on its website including a free download of General Chapter <797> for a limited period of time and information on USP on Compounding: A Guide for the Compounding Practitioner.
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 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.
- 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 was published in USP 36–NF 31 and becomes official in May, 2013. Considerable positive media attention resulted from the release of this general chapter.
- USP formed a Monograph Naming Advisory Group that developed and executed a plan for coordinating with FDA and informing manufacturers and 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 policy becomes official in May, 2013.
- General Chapter <1066> Physical Environments that Promote Safe Medication Use will be revised to include a broader range of environments and address multi-tasking, distractions interruptions, etc.
- Outreach to industry and practitioners about USP’s standard for cautionary statements on ferrules and cap overseals will occur in 2013 in advance of the standard’s official date of December 2013.
- In 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 continues to promote this program to schools.