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Liz at Pharmacy Compounding Symposium

Pharmacy Compounding Symposium

Thursday, November 29, 2018 – Welcome Reception & Tour

Friday, November 30, 2018 - Symposium

Hancock Daniel’s Inaugural Pharmacy Compounding Symposium will bring together regulators and industry leaders at the federal and state level to discuss emerging legal and regulatory trends in compounding pharmacy. Among other topics, discussions will include the topics of recent FDA Guidance and USP <795>, <797> and <800> and where the co-regulatory scheme conflicts.

Who Should Attend? Anyone involved in compounding pharmacy operations, compliance, or other relevant roles related to these organizations (e.g., hospital, community, retail, home infusion, long-term care, specialty, etc.) including pharmacy owners and managers, compounding technicians, and in-house counsel.

Please register by September 30, 2018 via email to This email address is being protected from spambots. You need JavaScript enabled to view it. to secure your complimentary reservation. Please provide:

• first and last name, organization and title, contact phone number,

• preferred name tag information,

• whether you will you attend the VCU welcome reception, and

• whether you will be staying at the Hilton or driving to the event.

Registrants will receive a confirmatory email. Hancock Daniel reserves the right to limit attendance.

A block of rooms has been reserved at a discounted rate of $139.00 per night. Attendees should contact the hotel directly at 804-344-4300 to secure the discounted rate.

Location: Hilton Richmond Downtown

501 E Broad St, Richmond, VA 23219

804-344-4300

This symposium will be conducted in compliance with the Accreditation Council for Pharmacy Education (ACPE) criteria for planning and implementation. More information to come on available contact hours of ACPE credit.

Questions? Please contact Wendy White at This email address is being protected from spambots. You need JavaScript enabled to view it. or 866-967-9604 x 463.

Agenda

Thursday, November 29, 2018

6:00 - 7:30 p.m. Welcome Reception

Please be sure to join us at our Welcome Reception for a tour of the Virginia Commonwealth University School of Pharmacy’s Center for Compounding Practice and Research. Joseph T. DiPiro, Pharm.D., dean of the VCU School of Pharmacy and Barbara Exum, Pharm.D., Director, Center for Compounding Practice and Research. VCU School of Pharmacy will provide insights into this state-of-the-art sterile medication compounding facility - one of only a few of its kind in the country. A shuttle will run transportation service between the hotel and the event.

Location: VCU’s Robert Blackwell Smith Building

410 N. 12th Street, 5th Floor

Richmond, VA 23284

Friday, November 30, 2018

Location: Hilton Richmond Downtown

8:00 – 8:30 a.m. Breakfast and Networking

8:30 – 9:00 a.m. Opening Remarks: The Challenge of Compliance

Presenter: Mary Malone, Esq.

9:00 – 9:30 a.m. Pharmacy Compounding: A Regulatory Overview

Presenter: Elizabeth Whalley Buono, RN, MBA, JD

Those engaged in compounding activities face unique issues as they balance federal and state regulatory requirements. This session will provide a brief history of the U.S. human drug compounding regulatory timeline and associated drivers, including the fungal meningitis outbreak from contaminated compounded drugs, FDA’s extension of authority beginning in the early 1990’s through enactment of the Compounding Quality Act (“CQA”) and more recent changes regulatory roles and engagements.

9:30 – 10:30 a.m. Panel Discussion: State Board of Pharmacy Regulatory Considerations

Moderator: Jerry Canaan, Esq.

Panelists:

• Caroline D. Juran, Executive Director, Virginia Board of Pharmacy

• W. Scott Johnson, JD, Hancock Daniel

• Patricia Crawford, President and Founder of LTCPCMS. Inc.

• Suzanne Kluge, RPh, BS Pharm, Corporate Director, Clinical Education, Option Care (national with infusion and specialty – speak to multistate issues)

This session will provide an in-depth and unique perspective into the role of the State Boards of Pharmacy in governing the practice of pharmacy compounding, coordinating with FDA, engagements with the Board from the pharmacy and counsel perspectives and recent developments in California, Texas, New Hampshire and Massachusetts. A moderated Q&A session will discuss emerging issues related to compounding, outsourcing, shared services, and technology's impact on the practice of pharmacy.

10:30 – 11:00 a.m. Break

11:00 – 12:00 p.m. Panel Discussion: Compounding Pharmacy Perspectives

Moderator: John O. Beckner, RPh, Senior Director, Strategic Initiatives, NCPA

Panelists:

• Jon Pritchett Pharm.D., RPh, Associate Director of Pharmacy, Accreditation Commission for Health Care (ACHC)

• Michael Foer, Foer's Pharmacy

• Cheri Garvin, RPh, CEO, The Compounding Center

This session will explore key issues faced by compounding pharmacies and outsourcing facilities. Topics include FDA oversight, audit processes, registration requirements, accreditation, and billing and reimbursement issues. Presenters also will highlight some of the regulatory issues related to sterile compounding and infusion.

12:00 – 1:00 p.m. Working Lunch / Panel Discussion: Hospital and Health System Perspectives

Moderator: Barbara Exum, Pharm.D., Director, Center for Compounding Practice and Research. VCU School of Pharmacy

Panelists:

• Rodney Stiltner, Pharm.D., MS, President, The Virginia Society of Health-System Pharmacists (VSHP)

• Rafael Saenz, Pharm.D., MS, FASHP, Administrator, Pharmacy Services, University of Virginia Health System, Assistant Dean, VCU School of Pharmacy – UVA Division

• Susan Kleppin, RPh, FASHP, Director of Pharmacy, Chartwell Midwest Wisconsin

Pharmacies located within a health system or standalone infusion pharmacies frequently provide compounded drug products for administration within the hospital, health system or home. Some of these pharmacies have registered with the FDA as 503B and others are state-licensed pharmacies subject to section 503A. This session will discuss critical concerns and challenges faced by licensed pharmacists, physicians or other health care practitioners in state-licensed hospitals, health system pharmacies, ambulatory infusion centers and home infusion pharmacies.

1:00 – 1:30 p.m. Break

1:30 – 2:00 Drivers of Change: Innovation, Convergence, Values and Culture

Panelists:

• Jeffrey M. Gallagher, CEO, VaBio

• Danny Barnes, Pharm.D, RPh, Chief Pharmacy Officer, Panaceutics

This session will provide insights into the drivers behind the changing context and forces in which the compounding pharmacy industry operates, specifically: scientific discovery and innovation; the convergence of disciplines leading to changes in the way therapies are developed, delivered and administered; shifting values society holds and regulators respond to, such as the “value” and price of a pharmaceutical therapy; and evolving cultural norms, such as attitudes about a patient’s “right to try” experimental medication and about access to marijuana for medical use.

2:00 – 3:00 Current Trends in Government Investigations, Suits, and Settlements

Panelists:

• Ruth A. Carter, DPM, Diversion Program Manager, Drug Enforcement Administration

• Eric Atkinson, JD, Hancock Daniel

The regulatory scrutiny by local, state, and federal government authorities is continuing to evolve. Pharmacies and others are not only defending against disciplinary claims, but recently have begun facing increasingly creative litigation claims by governmental authorities. This session will provide an overview of some of the national investigatory, disciplinary, and litigation trends; practical tips for managing governmental investigations and discovery; and examine how to best manage (and hopefully resolve) such cases.

3:00 – 3:45 p.m. Audience Open Question Session / Closing Remarks – Mary Malone, Esq.