Hancock Daniel joins VCU and Virginia Bio for an Inaugural Pharmacy Compounding Symposium in November
Richmond, VA, October 19, 2018– This Inaugural Pharmacy Compounding Symposium will be held on Friday, November 30, 2018, with a Welcome Reception and Pharmacy Tour kicking off the event on Thursday, November 29, 2018. Virginia Commonwealth University, as well as Virginia Bio will join Hancock Daniel to bring together regulators and industry leaders at the federal and state level to discuss emerging legal and regulatory trends in pharmacy compounding. 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.
Attendance at the event (including CE credit) is free of charge to the first 150 registrants. Content will be relevant to anyone involved in pharmacy compounding operations (e.g., hospital, community, retail, home infusion, long-term care, specialty), including pharmacy owners and managers, compounding technicians, and in-house counsel. The symposium will be conducted in compliance with the Accreditation Council for Pharmacy Education (ACPE) criteria for planning and implementation. Space is limited and those who plan to attend should register by November 5, 2018, by sending an e-mail to wwhite@hancockdaniel.com.
“Current market drivers including improved life expectancy and increasing drug shortages are anticipated to further accelerate the growth of the pharmacy compounding market,” says Mary Malone, a founding partner at Hancock Daniel. “Today, there are a record number of compounding pharmacies that supply customized drugs to patients whose needs are not met by commercially available drugs. This is a highly regulated industry at both the state and federal level and navigating those sometimes-divergent regulatory landscapes can be tricky.”
Elizabeth Whalley Buono, Director at Hancock Daniel says, “We are optimistic that this symposium will provide the most up-to-date information about a broad array of important issues including how the FDA is working with state partners to assure that they are able to address the risks that may be presented by compounded drugs. We anticipate informative dialogue among this region’s leaders in compounding practice, regulation and counsel, and we are very pleased that we have received conditional approval from the APCE to be able to offer continuing education credits for the attendees.”
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A formal agenda for the event can be found below:
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:
- Lori A. DeVito, RPh, Compounding Pharmacy Specialist, 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.
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If you would like more information about this topic, please contact Adrian Robinett at 866.967.9604 or email at arobinett@hancockdaniel.com.
