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Joint Commission of Pharmacy Practitioners Tuesday, August 25, 2015Alexandria, Virginia

Ronald T. Piervincenzi, Ph.D. Chief Executive Officer

USP: Update

‣ Overview of USP

‣ USP’s 2015–2020 Strategy

‣ USP program highlights

‣ Conclusion

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From 11 Founders with Bold Vision in 1820… to Today

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From 11 Founders with Bold Vision in 1820… to Today

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Almost 200 Years of Building and Advancing the Founder’s Vision

USP Governing and Advisory Bodies

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450+ Organizations

Academic Institutions and Associations Thereof

Health Practitioner Professional and Scientific Associations

Manufacturer, Trade, and Affiliated Associations

Governmental Bodies, Divisions and Associations Thereof

Consumer and Other Organizations Representing the Public Interest

Non-governmental Standards-setting and Conformity Assessment Bodies

‣ Meets every 5 years to: Elect officers and trustees

Elect the Council of Experts (Expert Committee Chairs)

Adopt resolutions

Adopt changes to Bylaws

USP Convention Membership

USP Board of Trustees 2015‒2020

PresidentJesse L. Goodman, M.D., M.P.H.

TreasurerJohn E. Courtney, Ph.D.

Past PresidentTimothy R. Franson, B.S. Pharm., M.D

Pharmaceutical Sciences TrusteeGregory E. Amidon, Ph.D.

Public TrusteeLaura S.L. Herman, M.B.A., M.A.

Medical Sciences TrusteeStephen P. Spielberg, M.D., Ph.D.

At-Large TrusteeSusan C. Winckler, R.Ph., J.D.

Pharmaceutical Sciences TrusteeMarilyn K. Speedie, Ph.D.

At-Large TrusteeThomas R. Temple, B.S. Pharm., M.S., FAPhA

At-Large TrusteeGail R. Wilensky, Ph.D.

Chief Executive OfficerRonald T. Piervincenzi, Ph. D

Medical Sciences TrusteeRobert J. Meyer, M.D.

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2015–2020 Council of Experts - Demographics

1. Argentina 2

2. Australia 1

3. Austria 1

4. Belgium 3

5. Brazil 3

6. Canada 22

7. China 7

8. Czech Republic 1

9. Denmark 3

10.France 5

11.Germany 11

12. India 12

13. Ireland 2

14. Israel 3

15.Japan 2

16.Jordan 1

17.Netherlands 1

18.New Zealand 2

19.Portugal 1

20.Russian Federation 1

21.Spain 3

22.Sweden 1

23.Switzerland 4

24.Taiwan 1

25.United Kingdom 9

• 398 members and chairs serving on 24 Expert Committees

– 102 (26%) international experts from 25 countries:

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USP Operations Globally

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USP Global Laboratory Capacity

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USP Compendia and Reference Standards

USP Compendia Over 5,900 monographs covering:• Pharmaceuticals• Food ingredients• Herbal medicines• Dietary supplements

USP Reference Standards Over 3,400 Reference Standards now available:

– Support FDA-enforceable standards and tests in the USP-NF

– Highly pure, with purity values provided for quantitative standards

FDA reviews proposed standards in PharmacopeialForum and provides comments

Participates as delegates, provides resolutions, provides members to the council of the Convention and other Convention committees

Provides FDA liaisons to USP’s expert committees

Participates in workshops and stakeholder forums

Works with USP through cooperative research and development agreements

Collaborates with USP through quarterly meetings, pharmacopeial discussion group and special topics such as OTC monograph modernization, compounding, structured product labeling, pharmacologic classes

USP and the FDA: FDA engagement goes beyond enforcing our standards

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‣ Overview of USP

‣ USP’s 2015–2020 Strategy

‣ USP program highlights

‣ Conclusion

Celebrating AccomplishmentsLooking to the Future

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New Strategy Aligned with Existing Mission

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New Strategy Aligned with Existing Mission

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New Strategy Aligned with Existing Mission

‣ Overview of USP

‣ USP’s 2015–2020 Strategy

‣ USP program highlights

‣ Conclusion

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USP and Dietary Supplements – driving awareness and adoption

What we offer: • Official and FDA recognized

standards for manufacturers to adopt in order to ensure that the supplements they make adhere to the strictest quality and purity standards

• A voluntary verification program for manufacturers to join provide the customer the assurance that what is on the label is in the bottle

Our goal: Better quality of dietary supplements and impact on public health through increased adoption of USP public standards

• Raise awareness of USP among policy makers

• Educate consumer groups and healthcare practitioners and engage them as advocates

• Encourage industry adoption of our standards

Convention Resolution VI. USP will promote alignment with stakeholders to develop quality standards for biological medicines, ensuring that innovation and availability are facilitated and complemented

Our strategy and plan: Continue to develop and improve USP’s portfolio of quality standards for biological medicines:

• Continue to modernize standards for legacy products• Continue to eliminate animal-based bioassays• Grow portfolio of ancillary and raw materials standards• Grow portfolio of procedural and system suitability tools for

the analysis of all biologics• Development new standards for biologics based on broad

understanding of public health, regulatory, and technology impact

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USP and Biologics – investing to grow our impact and maintain future relevance

Endorsed

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The Medicare Modernization Act of 2003 codified USP role in defining formulary categories and classes and updating them on a regular basis

These USP Medicare Model Guidelines are now being used to inform the ACA*’s “Essential Health Benefit” (EHB) categories, for which a minimum prescription coverage is mandatory

23*Affordable Care Act

USP and Healthcare Quality Standards: a legal mandate to set and update Medicare formulary categories and classes

USP and Compounding: Impacting day-to-day practices in many pharmacies

Chapter 795: Pharmaceutical Compounding – NonsterilePreparations: Guidance on good compounding practices for nonsterile formulations for humans or animals

Chapter 797: Pharmaceutical Compounding – Sterile Preparations: Practice and quality standards for compounded sterile preparations to prevent harm, including death, to patients that could result from contaminants or variablity of intended strength In revision and targeted for publication on September 25, 2015

Chapter 800 (proposed): Hazardous Drugs – Handling in Healthcare Settings: Define processes to protect personnel and environment when handling hazardous drugs Currently proposed – to be balloted by EC prior to publication

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USP’s Global Public Heath Program

Objective 1: Ensure the availability of relevant public standards for the world’s most essential medicines

Objective 2: Support the global manufacturing sector to increase the supply of quality assured medicines

Objective 3: Strengthen regional regulatory systems and improve quality control laboratory capacity

Medicines Quality Monitoring

90% of Oxytocin and Ergometrin failed quality specifications

High failure rate in public sector

90% of products not registered

Over 80% of products not stored properly

Power of Post market Surveillance–Case study Ghana

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‣ Overview of USP

‣ USP’s 2015–2020 Strategy

‣ USP program highlights

‣ Conclusion

USP’s mission is: “To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods”

We will continue to seek to maximize our mission impact and relevance through:– Investing in USP NF Up to Date – Growing awareness and adoption of our standards in dietary supplements – Further strengthening our work in healthcare quality standards and compounding – Continuing to build our biologics program – Growing our global public health programs

Effectively engaging our volunteers, member organizations and other constituents is critical to our success

Pharmacists play a special role as we champion, together, the shared objective of improving the quality, safety and benefit of medicines

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Conclusions