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

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

Topics

USP’s Mission

To improve the health of peoplearound the world through public standards

and related programs that help ensurethe quality, safety, and benefit of

medicines and foods.

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-makersInternationally recognized and globally focused

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

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)

2010–2015 USP Council of Experts

7

• 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)

2010-2015 Council of Experts - Demographics

* This number does not include Expert Committee members also serving on Expert Panels.

• 738 Expert Committee and Expert Panel members– 216 (29%) international experts from 34 countries:

1. Argentina 2

2. Australia 3

3. Austria 2

4. Belgium 4

5. Brazil 8

6. Canada 25

7. Chile 2

8. China 32

9. Colombia 2

10. Costa Rica 1

11. Denmark 7

12. France 10

13. Germany 20

14. India 42

15. Israel 2

16. Italy 4

17. Japan 1

2010-2015 Council of Experts - Demographics

18. Jordan 2

19. Mexico 4

20. Netherlands3

21. Peru 2

22. Portugal 2

23. South Africa1

24. Saudi Arabia1

25. Scotland 1

26. South Korea1

27. Spain 1

28. Sweden 2

29. Switzerland8

30. Taiwan 1

31. Ukraine 1

32. United Kingdom 21

33. Uruguay 1

34. Venezuela1

Core USP Compendia

1. The United States Pharmacopeia

2. National Formulary (USP–NF)

3. Food Chemicals Codex (FCC)

4. USP Dietary Supplements Compendium (DSC)

5. USP Medicines Compendium (MC)

6. USP on Compounding

7. Coming soon: Herbal Medicines Compendium (HMC)

Other Resources

– Pharmacopeial Forum (PF)– FCC Forum (FCCF)– USP Dictionary– Chromatographic Columns

USP Reference Standards

Trusted for pharmaceutical quality control worldwideOver 2,900 Reference Standards now availableSupport FDA-enforceable standards and tests in

the USP–NF Highly pure, with purity values provided for quantitative standardsStocked and ready to ship same day

(2-day delivery within U.S.)

USP–NF Translations

Spanish Translation Russian Translation

In the works…Chinese Translation

USP Medicines Compendium: www.usp-mc.org

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

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

Elemental Impurities Postponement

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

Watch for Updates on the Key Issues Page

http://www.usp.org/usp-nf/key-issues/elemental-impurities

USP’s Key Issues

http://www.usp.org/usp-nf/key-issues

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

USP’s Response to the Compounding Crisis

http://www.usp.org/usp-healthcare-professionals/compounding

Monograph Naming Policy, May 1, 2013

http://www.usp.org/usp-nf/development-process/compendial-nomenclature/monograph-naming-policy

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> Nomenclature

Finalized 2007; Official May 1, 2013

Improvement: Searchable Errata

http://www.usp.org/usp-nf/official-text/errata

Pubs 1.0 Delivery

USP

1. Multiple delivery platforms, but optimized for print.2. Forum is independent. Feedback through private email

to liaison.3. All customers and staff see the same thing.

Pubs 2.0 Delivery

1. Delivery optimized for each of multiple platforms.2. Forum is integrated. Feedback can be private or public.3. Different customers may see different content,

dependent on subscriptions or personalization.

USP

xml

USP Food Chemicals Codex

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

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

Official USP-NF Publications

USP World Regions

USP Global Sites

New USP-India Site

Inauguration September 2, 2011

China Expansion—Fall 2013

Building Today Architect’s Rendering

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

Opportunities to Get Involved with USP

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.

Visiting Scientist Program

For more information, please contact Nilsa Esters at:

nbe@usp.org

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.

Global Fellowship Awards Program

For more information, please contact Helen Kharab at:

hk@usp.org

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.

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.

International Training Program