6 th Annual Science and Standards Symposium January 16, 2013 Istanbul USP Compendial Updates

1. 6th Annual Science and Standards SymposiumJanuary 16, 2013Istanbul USP Compendial Updates Angela G. Long, M.S.Senior Vice President, Global Alliances and Organizational Affairs/Executive Secretariat

2. Topics • USP Mission and Overview • USP Council of Experts • USP’s Core Compendia and Reference Materials • Compendial Updates • USP in the World • How to Get Involved with USP

3. USP’s Mission To improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

4. USP – An Overview • Since 1820, nonprofit, private, independent, and self-funded • Headquartered in Rockville, Maryland; 700+ employees; facilities in India, China, Switzerland, Brazil, and Ethiopia • Expert volunteers are scientific decision-makers • Internationally recognized and globally focused

5. USP’s Statements on Standards • Modern public standards should exist for all medicines and foods • Public standards play a key role in ensuring quality, safety and benefit by allowing independent testing • USP standards are science-based and data-driven • USP is not involved in market access or regulatory approval decisions • USP RS may have multiple compendial uses, and are made available to the public without restriction • USP works in many ways to promote harmonization • USP partners with pharmacopeias and regulatory authorities throughout the world to support their work and increase availability of public standards

6. USP and NF are Official Compendia USP is cited in law… • 1848: Drug Import Act • 1906: 1906 Pure Food and Drugs Act • 1938: Food, Drug and Cosmetic Act • Definition of a drug • Adulteration • Misbranding • Drug product name • 1994: Dietary Supplement Health Education Act • 2003: Medicare Modernization Act (Model Guidelines for Medicare Formularies)

7. 2010–2015 USP Council of Experts

8. 2010-2015 Council of Experts - Demographics • 861 expert volunteers serving on 24 Expert Committees and 65 Expert Panels • 366 Expert Committee members • 372 Expert Panel members* • 123 Government Liaisons • 111 FDA Liaisons • CDER: 76 ─ CVM: 6 • CFSAN: 13 ─ORA: 3 • CBER: 12 ─CDRH: 1 • 3 Chinese Pharmacopoeial Commission Representatives • 1 European Food Safety Authority Representative • 2 Health Canada Representatives • 1 Indian Pharmacopoeial Commission Representative • 1 NIST Representative • 3 Brazil (ANVISA, Brazilian Pharmacopoeia, INCQS) • 1 CCAYAC/COFEPRIS (Mexico) * This number does not include Expert Committee members also serving on Expert Panels.

9. 2010-2015 Council of Experts - Demographics • 738 Expert Committee and Expert Panel members • 216 (29%) international experts from 34 countries: • Argentina 2 • Australia 3 • Austria 2 • Belgium 4 • Brazil 8 • Canada 25 • Chile 2 • China 32 • Colombia 2 • Costa Rica 1 • Denmark 7 • France 10 • Germany 20 • India 42 • Israel 2 • Italy 4 • Japan 1 • Jordan 2 • Mexico 4 • Netherlands 3 • Peru 2 • Portugal 2 • South Africa 1 • Saudi Arabia 1 • Scotland 1 • South Korea 1 • Spain 1 • Sweden 2 • Switzerland 8 • Taiwan 1 • Ukraine 1 • United Kingdom 21 • Uruguay 1 • Venezuela 1

10. Core USP Compendia • The United States Pharmacopeia • National Formulary (USP–NF) • Food Chemicals Codex (FCC) • USP Dietary Supplements Compendium (DSC) • USP Medicines Compendium (MC) • USP on Compounding • Coming soon: Herbal Medicines Compendium (HMC) • Other Resources • Pharmacopeial Forum (PF) • FCC Forum (FCCF) • USP Dictionary • Chromatographic Columns

11. USP Reference Standards • Trusted for pharmaceutical quality control worldwide • Over 2,900 Reference Standards now available • Support FDA-enforceable standards and tests in the USP–NF • Highly pure, with purity values provided for quantitative standards • Stocked and ready to ship same day (2-day delivery within U.S.)

12. USP–NF Translations Spanish Translation Russian Translation In the works…Chinese Translation

13. USP Medicines Compendium: www.usp-mc.org

14. Unique Aspects of the Medicines Compendium • Web-based, online only; open access to documentary standards, including general chapters • Performance Based Monographs with USP-developed Reference Procedures • Use of Certified Reference Materials for assays; Reference Standards for Impurities • Public availability of the validation data • Monographs for some medicines that have never before had public monographs • MC Expert Committees meet in USP global regions • MC Expert Committee adopts USP-NF general chapters including some general chapters that are planned or proposed in USP-NF but not yet official, e.g., <232> and <233> for elemental impurities • Simplified, easy to access

15. Compendial Updates • Elemental Impurities (General Chapters <232> and <233>) postponement • Other USP Key Issues • Proposed Changes to General Notices • USP Response to the Compounding Crisis in the US—methylprednisolone acetate • Monograph Naming Policy • Publications Enhancements • Searchable Errata • Future: Publications 2.0

16. Elemental Impurities Postponement http://www.usp.org/usp-nf/official-text/revision-bulletins/elemental-impurities-limits-and-elemental-impurities-procedures

17. Watch for Updates on the Key Issues Page http://www.usp.org/usp-nf/key-issues/elemental-impurities

18. USP’s Key Issues http://www.usp.org/usp-nf/key-issues

19. Proposed Revisions to General Notices http://www.usp.org/usp-nf/notices/proposed-revisions-general-notices-and-requirements-published-comment-pharmacopeial-forum-391-jan-feb-2013

20. USP’s Response to the Compounding Crisis http://www.usp.org/usp-healthcare-professionals/compounding

21. Monograph Naming Policy, May 1, 2013 http://www.usp.org/usp-nf/development-process/compendial-nomenclature/monograph-naming-policy

22. Monograph Naming Policy, Official May 2013 • Drug product monograph titles will include only the active moiety • Strength also will be expressed in terms of the active moiety • The names and strengths of both the active moiety and specific salt form (where applicable) are provided elsewhere on the label • Included in General Chapter <1121> NomenclatureFinalized 2007; Official May 1, 2013

23. Improvement: Searchable Errata http://www.usp.org/usp-nf/official-text/errata

24. Pubs 1.0 Delivery USP Multiple delivery platforms, but optimized for print. Forum is independent. Feedback through private email to liaison. All customers and staff see the same thing.

25. Pubs 2.0 Delivery USP Food Chemicals Codex xml USP Delivery optimized for each of multiple platforms. Forum is integrated. Feedback can be private or public. Different customers may see different content, dependent on subscriptions or personalization.

26. PF Publications • Currently • A PF issue is published every 60 days and has a 90-day public review and comment period • Current publication schedule results in overlapping comment periods (i.e., the first 30 days and last 30 days overlap with other issues of PF) • For USP staff, there are overlapping deadlines with no room for adjustments • Proposed Change • Change from six to four PF issues per year, each with its own 90-day comment period: Feb, May, Aug and Nov • Implement in 2014 at the earliest • Benefits • Eliminates overlap allowing each PF to have its own uninterrupted comment period • Eases internal processes

27. Official USP-NF Publications • Current • USP-NF Book and two Supplements are published each year based on six PF issues • Takes 16 to 18 months for a PF proposal to reach the official date of the original target publication (assuming no deferral) • Proposed Change • Online USP-NF becomes the primary publication and consider options for print publication(s) • Change from six to four PF issues each year and ballot Expert Committees after each PF therefore four official updates per year • Incorporate Accelerated Revisions into the four official publication • Implement in 2014 at the earliest (change to PF schedule); details are evolving regarding the changes to the official publication schedule • Benefits • Shorten time from initial PF proposal to official date estimate is about 13 months, assuming no deferral • Will eliminate looking for new official text in multiple places; needs of print customers to be considered

28. USP World Regions

29. USP Global Sites

30. New USP-India Site Inauguration September 2, 2011

31. China Expansion—Fall 2013 Building Today Architect’s Rendering

32. Opportunities to Get Involved with USP • Comment on proposed revisions through the online Pharmacopeial Forum • Participate in Expert Committees, Expert Panels • Calls for Candidates for Expert Panels ongoing • Call for Candidates for the 2015-2020 Council of Experts coming Fall 2013 • USP-sponsored Regional Laboratory Networks • Visiting Scientist Program • Global Fellowship Award Program • International Training Program • Science Meetings

33. Visiting Scientist Program Promotes the scientific exchange Hosts scientists from other countries at USP to strengthen the alignment of the participants’ technical competence and experience with USP’s technical needs and objectives. The program typically a three-month visit to USP’s headquarters in Rockville, Maryland or to one of USP’s international sites, where participants work hand-in-hand with USP scientific and technical staff on projects of mutual interest. Participants are selected via a competitive nomination process. For more information, please contact Nilsa Esters at: nbe@usp.org

34. Global Fellowship Awards Program Provides support to students whose research directly addresses specific USP scientific or research needs. Awards three $50,000 Fellowships to students who have been accepted for full-time study in a Ph.D. or Pharm.D. program or medical or dental school, or have been awarded a postdoctoral research (non-faculty) appointment. The program allows for subsequent yearly- funding for up to three years. USP Research Fellows are selected through a review process to ensure the alignment of the proposed research with specific areas of USP research needs. Fellows work closely with USP scientific and technical staff throughout the academic year and present their research results to USP standards-setting bodies. For more information, please contact Helen Kharab at: hk@usp.org

35. International Training Program Promotes the exchange of scientific expertise between global organizations committed to the quality of medicines and foods. Strengthens, expands, and enhances existing compendial and regulatory knowledge base. Participants receive training with USP scientific and technical staff on compendial topics. Curriculum includes classroom study supplemented by laboratory learning.

36. International Training Program Two-week program at USP headquarters in the United States. Priority is given to USP global collaborators established through agreements and activities as part of USP’s strategic efforts in regions and countries. Participation is open to national and regional OMCL’s, pharmacopoeias, and other government agencies. For more information, please contact Linda Stelling at ljs@usp.org.