Adopted by the USP Convention membership on April 24, 2010.
March 2014 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 February 20, 2014 member appointment is at 98%—total membership is 449, and there are 10 member organizations that do not have 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, further reviews continue 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 continues to explore ways to gain timely information and candidate materials to support its public standards. Further, USP has worked to build approaches that allow USP to develop documentary and reference material standards for foods and drugs independent of a donor. These approaches are being 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. The FDA website now includes a link to the USP modernization webpage.
- 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. In addition, an increased interaction between the responsible liaisons of both the monographs and the chapters is providing procedural advantages to work in a synchronized fashion to achieve greater standards alignment.
- The consolidation of the reference materials division and documentary standards division into a single Global Science and Standards Division streamlined the documentary and physical standards processes and further integrated the Quality Assurance (QA) department 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.
USP increased the involvement of its QA department in its documentary standards activities to help ensure conformance to processes. QA now has a sampling plan for all types of documentary standards in all compendia (see the table below). The sampling plan is based on a variation of n+1 theory except for new compendia where there is 100% review. Based on trends observed in the first six months of sampling, a new Business Process Management Cross Functional Group (BPM CFG) has mapped and redefined the documentary standards processes to simplify steps and fill in gaps where they exist. The changes have decreased observations and increased adherence to USP's documentary standards processes. 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. ADAM
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 is placing special emphasis on the modernization of monographs for over the counter (OTC) drug products marketed under the FDA monograph system, and works to obtain FDA’s input on new approaches for modernization of these standards that will complement FDA’s efforts to improve regulation of OTC 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. Under this CRADA, FDA laboratories participate in collaborative testing of USP reference standards, primarily controlled substances, and USP and FDA labs are working together to develop methods to support modernization of tests and assays in USP’s documentary standards This CRADA is being renewed in 2014 to expand the testing and other work performed by the parties and extend the term for an additional three years.
USP and FDA are also parties to a Substance Registration System CRADA 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.
Under a grant provided in 2013, USP is working to support FDA’s efforts to create a spectral library that can be used in handheld devices to detect counterfeits and substandard products. USP is providing USP Reference Standard spectra for excipients and also is collaborating with FDA on a roadmap to build a global spectral library that could be utilized by regulators, industry and others throughout the world.
USP has collaborated with FDA on several patient safety-related projects during the cycle. 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 has held meetings with staff in FDA’s Office of Global Regulatory Operations and Policy to explore ways USP and FDA can 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; and utilizing USP’s international site laboratory capabilities to assist FDA’s efforts to assure the quality of products imported to the US. There is also ongoing communication between FDA field offices and USP’s overseas sites.
In 2013, USP’s Chief Legal Officer spent six months in FDA’s Office of Global Regulatory Operations and Policy under an Interagency Personnel Agreement between USP and FDA, focusing on FDA’s implementation of Title VII of FDASIA which provides new authorities to FDA to address global supply chain challenges.
With the passage of the Drug Quality and Security Act in 2013, USP’s compounding general chapters (<795> and <797>) have taken on heightened importance in ensuring the safety and quality of compounded preparations. USP and FDA are collaborating on the revision of <797> to provide better clarity in the standard for practitioners and regulators.
Following his arrival in February 2014, USP’s new Chief Executive Officer, Ron Piervincenzi, had introductory meetings with the Directors of CDER and the Center for Biologics Evaluation and Research (CBER) and other key FDA staff to learn how USP can strengthen its collaboration with and support for FDA.
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
- USP expanded its presence in India 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).
- USP expanded its facility in Shanghai, China and inaugurated the new expanded site in January, 2014. The site is 95,000 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, Middle East North Africa (MENA), and South East Asia. The most recent additions include Thailand, the Official Medicines Control Laboratory (OMCL) in Ho Chi Minh City, Vietnam, which operates in the southern part of the country, and Cambodia. 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.
- In conjunction with TAP, USP continues to build its network of official medicines control laboratories (NOMCOL). For Asia, USP held its inaugural meeting in Cambodia in February; representatives from six national OMCLs and one from Association of Southeast Asian Nations (ASEAN) participated. For the MENA region, two new members were added, Algeria and Oman, bringing the membership in that region to seven. A NOMCOL website has been developed to facilitate communications among participating laboratories.
- 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. USAID has extended the PQM funding and cooperative agreement to 2019. 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 2013, in conjunction with Boston University, PQM supported the development of a new detection technology based on microfluidics. “PharmaCheck” is considerably smaller and more transportable than the Minilab©, which weights ~70 Kilos, and as testing requires less reference sample, should lower the cost of testing. The technology is anticipated to go for pilot field testing at USP’s newly established CePAT Center in Accra, Ghana in early 2014
- After endorsement by the USP Board of Trustee in 2012, the Center for Pharmaceutical Advancement and Training (CePAT) was inaugurated on May 13, 2013, in Accra, Ghana. Prominent national and international dignitaries as well as USP board members and staff attended the opening ceremonies. Miss Sherry Hanny Ayittey, Minister of Health for the Republic of Ghana, and The Honorable Mr. Gene A. Cretz, U.S. Ambassador to Ghana emphasized that having a well-trained workforce is crucial to combating substandard and counterfeit medicines and ultimately will help Ghana and other Sub-Saharan African nations provide access to good quality medicines to their populations.
- 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 45 of 62 excipient monographs (as of the Tokyo meeting in November 2013) 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, and JP). The next meeting is in Rockville, Maryland, June 25-26, 2014. 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.At its November 2013 meeting in Tokyo, Japan, PDG considered a request from the Indian Pharmacopoeia to join as an observer to PDG. PDG members have decided to first review PDG’s processes prior to enabling this involvement. USP will host the early discussions on this topic at the June 2014 meeting.
- USP continues to work 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. The pilot has continued with one manufacturer, and now is in its third round of activity with additional drug substance monographs.
- 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. USP has continued this activity with the same manufacturer above, with additional drug product 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 as one possible way of developing 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 assisted 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 three Global Summits of the Pharmacopeias (Beijing in November 2011, Xi’an in September 2012, and Baltimore in September 2013). Representatives from 16 pharmacopoeias (including WHO’s International Pharmacopoeia) attended the first meeting, 11 pharmacopoeias were present for the second Summit, and 16 pharmacopoeias and one regulatory authority were present for the third meeting. Participants discussed issues and opportunities for: creating optimal public standards; strengthening collaboration among pharmacopoeias; and establishing information sharing mechanisms. As a result of these summits, the Chinese Pharmacopoeia is creating a database containing pharmacopoeial methods currently in use by seven of the pharmacopoeias.USP also participated at the senior management and Board level in three World Health Organization “International Meeting of the World's Pharmacopoeias:” one in February 2012 in Geneva, Switzerland; a follow-up meeting in Amsterdam, The Netherlands in October 2012; and in April 2013 in India. 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" (GPhPs), 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 group began the drafting process in earnest after the October 2012 meeting, and discussed the first draft of the GPhPs at the April 2013 meeting. The next WHO co-sponsored event is set for April 2014 in London, UK with the British Pharmacopoeia as co-sponsor.
- In January 2014, ChP and USP agreed to combine the Global Summit of the Pharmacopoeias with the World Health Organizations “International Meeting of World Pharmacopoeias,” with the desire for the topics of the Global Summit of the Pharmacopeias to continue in the WHO meeting.
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, 89 new monographs and 7 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 54 monographs and 6 Appendices have been modernized and others revised. USP published the FCC in its Ninth Edition in March 2014. In the same period, USP released 94 new reference materials (F-lots) for use in FCC monographs and incorporated 74 existing reference materials for new testing uses.
- USP has introduced through the FCC Forum a new type of standard, the FCC Identity Standard. The FCC Identity Standards were designed to help users determine the identity or authenticity of a food ingredient (particularly those that are very close to raw agricultural materials) for which a traditional FCC monograph does not exist. The first proposed FCC Identity Standard for Pomegranate Juice is scheduled to be published in the first supplement to FCC 9 in September, 2014.
- 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’s Food Additive Petition to update the federal regulations in 21 CFR Parts 172, 173, 178, and 180 to incorporate by reference FCC 7 was published in the Federal Register as a final rule on Friday, November 29, 2013. The rule is effective on November 29, 2013. USP’s citizen petition to FDA to update the references in the GRAS sections is still pending. USP intends to again petition FDA to update all references to FCC 9.
- Since the Convention in 2010, USP has reached out to the Congress to promote awareness, appreciation, and support for food ingredient standards. USP’s food scientists have been consulted by Congressional staff on a wide array of issues, including energy drinks, the GRAS process, and intentional adulteration of food ingredients.
- USP contacted FDA’s Center for Food Safety and Applied 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 moved to implement the Food Safety Modernization Act, which USP supported. USP also submitted regulatory comments related to implementation of the Food Safety Modernization Act, including supporting verification-related activities and measures to address economically-motivated adulteration. USP continues to work closely with stakeholders to advance these important objectives, including increased collaboration with the Grocery Manufacturers Association, consumer groups, and academia.
- 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 (www.foodfraud.org) provides baseline information to assist in assessing the risks to specific products. It includes a total of 2,000 records for food fraud based on a total of 1000 scholarly, media and other publicly available reports. The database continues to attract considerable interest from all external stakeholders (media, regulators, and industry).
- USP advanced several international cooperative efforts in its foods standards-setting areas. 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 complete and the Chinese version of FCC is available for purchase. USP and CFSA held workshops in Beijing in 2012 and 2014 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 as is the potential to expand activities at USP’s expanded China site.
- 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 and September 2013, USP held successful workshops 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 and in Israel and Turkey (2013). Other high-profile activities included visits to regulators and several academic institutions in Brazil, a workshop on probiotics, and the Standard and Science Symposium on Functional Foods and Dietary Supplements in 2012.
- USP is hosting an advisory group on skim milk powder with over 50 participants from over 20 organizations. The work of this advisory group resulted in 3 peer-reviewed publications, 3 new general tests and assays, the development of 5 new Reference Standards, with more output expected in 2014 and 2015.
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 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 towards release of the next edition of Dietary Supplements Compendium in April 2015 with enhanced content.
- Since the 2010 Convention, USP has developed 62 new monographs and introduced more than 60 new reference materials. During this time, 34 additional monographs and 45 modernizations have been proposed in Pharmacopeial Forum. New and revised General Chapters provide tools to detect irradiation of dietary supplements and DNA-barcoding and chromatographic methods for botanical identification.
- 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 free online Herbal Medicines Compendium includes 15 completed/authorized monographs, 17 proposed for comment, and 26 other monographs that have been proposed for development. 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. This evidence-based review is published in the peer-reviewed journal Nutrition Reviews. Another Expert Panel finished the evaluation of Arginine and the second report was submitted in February 2013. The third project on assessing safety of multi-ingredient dietary supplements through a model-based approach is expected to be submitted in June 2014.
- USP formed an Expert Panel on Adulteration of Dietary Supplements with Drugs and Analogs to provide tools for analysis of adulteration in 3 categories that claim sexual-enhancement, weight loss, and sports / body-building. This project has high public health impact considering that these categories of dietary supplements present high regulatory concern due to safety implications.
- USP successfully organized workshops in November 2011 and September 2013 on adulteration of food and dietary supplements that received wide interest and participation from industry, regulators, and academia. USP Standard and Science Symposium in 2012 focused on Functional Foods and Dietary Supplements. Other outreach involved Stakeholder Forum meetings in August 2011, and May 2014 (planned). USP is working with US Department of Agriculture to organize a Workshop in October 2014 on DNA as a Quality Assurance Tool.
- USP is engaged with dietary supplement stakeholders through interactions with FDA (new Research Collaboration agreement; comment on proposed New Dietary Ingredient Notification Guidance), USDA (workshop on DNA as a QA tool), NIH (interactions with Office of Dietary Supplements; meetings regarding medical foods), AOAC (participation in Dietary Supplements Advisory Panel), trade associations (participation at trade shows), and manufacturers. Stakeholder outreach also involved media outreach, press releases, quarterly Dietary Supplement e-Newsletters, Pharmacopeial Education courses, and Congressional visits.
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 schools of pharmacy and commercial laboratories to perform method development, validation, and stability studies to support the development of compounding preparation monographs. Since the beginning of the cycle, 15 new compounded preparation monographs have been developed and proposed based on contract laboratory studies. Currently, there are 21 additional monograph studies in various stages of development, public comment, and approval.
- USP began a pilot project in September 2013 to evaluate the feasibility of using our internal laboratory to develop and validate stability-indicating assays and establish beyond-use dating for compounded preparation monographs proposed by the Compounding Expert Committee.
- 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). To date 569 copies have been purchased.
- USP continues to support the Pharmacy Compounding Accreditation Board (PCAB), which is a site accrediting activity, led by key pharmacy practitioner bodies. USP sits on the PCAB governing board and plays an active role as 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 was formed in early 2013, and USP is working closely with FDA and Centers for Disease Control and Prevention on the effort. The Expert Committee is developing two new general chapters: Compounding for Investigational Studies and Hazardous Drugs – Handling in Patient Care Settings.
- Sterile compounding came under scrutiny in 2012 due to more than 60 deaths reported across the US from an apparent contamination of a compounded steroid preparation prepared by a compounding pharmacy in Massachusetts. 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. USP also instituted a program offering free user licenses of USP-NF to all state compliance officers. As of March 2013, 39 states have registered for the program.
- USP worked closely with both the House and Senate staff as a resource expert on <797> as the Drug Quality and Security Act of 2013 was being developed.
- In December 2013, USP hosted a compounding meeting inviting compounders and analytical testing laboratories to discuss ways USP may be able to fill gaps and address issues in the compounding environment to support practitioners and patients.
- USP developed courses on General Chapter <795> and <797> for inspectors /surveyors. The courses have been accredited for Continuing Education (CE) credits for both pharmacists and technicians. In addition, a Compounding Course was delivered in Brazil in association with ANFARMAG (Brazil’s compounding professional association) for practitioners and regulators.
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
- In 2014, USP completed the sixth revision of the USP Medicare Model Guidelines. This standard creates categories and classes for drug coverage in the Medicare Prescription Drug Benefit (Part D), as stipulated by the Medicare Modernization Act (2003). The Therapeutic Information and Formulary Support Expert Committee has future plans to evaluate the utility of the USP MMG v5.0 as named as a benchmark in the Affordable Care Act, and consider the public health need for additional formulary standards.
- 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 continues to 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 became official in May, 2013. Considerable positive media attention resulted from the release of this general chapter. The Prescription Container Label Expert Panel continues to assess the Department of Justice Access Board’s best practices for patient centered labels to expand the standard for the visually impaired.
- 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 became official in May, 2013.
- General Chapter <1066> Physical Environments that Promote Safe Medication Use will be revised to include advancements in research regarding physical environments that promote safe medication use. Made available for public comment in Pharmaceutical Forum in early 2014, the proposed revisions included a partial reorganization of the content to present the Medication Safety Zones section earlier in the general chapter for greater emphasis. In addition, the proposed revisions provide greater detail on the human factors that affect safe medication use. New sections are proposed to this general chapter to incorporate recent research on multi-tasking, the home environment, odors, temperature and humidity, and evidence-based design of the workplace. Minor editorial changes were made to update the chapter to current USP style.
- Outreach to industry and practitioners about USP’s standard for cautionary statements on ferrules and cap overseals continues. This standard became official on December 1, 2013.
- The Substance Registration System CRADA supports the FDA database and is a long-term project that ultimately will allow identification and coding of all substances in drug products, including process and degradation impurities. Future implementation will help dispensing safety, detect interactions, and possibly aid in pharmacovigilance measures. If European organizations are on board it will truly be a global effort.
- In 2011, USP launched the Academic Pharmacy Resource Program, through which schools of pharmacy can obtain site licenses of USP-NF at no charge, and can also obtain USP reference standards at reduced rates. With 93 schools enrolled, USP continues to promote this program to schools.
- Download a copy of the March 2014 2010–2015 Resolutions Status Updates
- Download a copy of the January 2013 2010–2015 Resolutions Status Updates
- Download a copy of the April 2012 2010–2015 Resolutions Status Updates