Join panels of key government regulators and industry experts to explore current issues surrounding the DQSA’s Title I (Compounding Quality Act) and II (Drug Supply Chain Security Act) – four years after implementation. Title I has had a significant impact in compounding pharmaceutical products by outsourcing facilities and traditional pharmacies. Review the changes in the law, FDA’s current guidance, regulatory responses and related state actions involving compounding. Title II has and will continue to have a significant impact on drug manufacturers, wholesalers and pharmacies, especially as they implement the next phases of the DSCSA and await additional FDA guidance.
Ilisa B.G. Bernstein, Deputy Director, Office of Compliance, CDER
Julie Dohm, Senior Science Advisor for Compounding, CDER
Title I – Compounding Quality Act (CQA)
Recent FDA guidances and enforcement discretion, an analysis on what’s on the horizon for compounders from a regulatory (FDA and state inspections) and legal (actions for non-compliance) perspective
Title II – Drug Supply Chain Security Act (DSCSA)
Recent FDA guidances, pilot projects, serialization and other related hot topics such as licensure of wholesale distributors and 3PL’s, and preemption issues
subject to change
Registration and Continental Breakfast
Welcome and Opening Remarks
Laura Brown, Director, Educational Programs, FDLI
Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC and Planning Committee Chair, Drug Quality and Security Act Conference
Keynote Address – Title I (Compounding Quality Act) Implementation – Pharmacy Compounding in 2017
Julie Dohm, J.D., Ph.D., Senior Science Advisor for Compounding, CDER, FDA
Introduced by Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC and Planning Committee Chair, Drug Quality and Security Act Conference
Keynote Address – Title II (Drug Supply Chain Security Act) Implementation Track and Trace Issues in 2017
Ilisa Bernstein, Pharm D., J.D. Deputy Director, Office of Compliance CDER, FDA
Introduced by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Member, FDLI Board of Directors
Concurrent Breakout Sessions
Title I (CQA) – Industry Update: FDA’s Significant Guidance Documents and Industry Actions/Reactions on Regulation of Compounding
In this breakout session, speakers will review FDA’s guidance for traditional compounders and outsourcing facilities under sections 503A and 503B, their practical applicability, and effects on both types of entities.
A.J. Day, Director of Clinical Services, PCCA
Alexander Pytlarz, Owner/Director of Pharmacy, The Compounding Center
Sara Rothman, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, CDER, FDA
Lee Rosebush, Chairman, Outsourcing Facilities Association and Partner, BakerHostetler
Moderated by Elizabeth R. Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Title II (DSCSA): – Industry Update: Recent Developments and Unanswered Questions Concerning Implementation of the DSCSA.
In this breakout session, speakers will discuss next steps in DSCSA implementation, including FDA guidance and regulatory developments and its effect on industry, the grandfather designation and product identifiers, FDA’s working groups/case studies process, and lingering questions, such as applicability of Title II to 503B repackaging facilities.
Anne Marie Polak, Senior Director, Leavitt Partners, LLC
Jennifer Zachary, Partner, Covington & Burling LLP
Scott Mooney, Vice President Distribution Operations, Supply Chain Assurance, McKesson Corporation
Moderated by Abraham Gitterman, Associate, Arnold & Porter Kaye Scholer LLP
Luncheon Presentation: DSCSA and Blockchain
Discussion of the utilization of blockchain as a possible way to address unresolved DSCSA data security issues.
Bob Celeste, Founder, Center for Supply Chain Studies
Update on states’ increased roles in the licensing and regulation of compounding and outsourcing facilities
Concurrent Breakout Sessions
Title I – FDA and Inspections: What to Consider When FDA Visits Your Facility
Panelists will discuss FDA’s inspection guidance, generally how to prepare for an inspection, what FDA may be looking for, and how to respond to Agency inquiries and observations.
Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Member, FDLI Board of Directors
Andrew Harrison, Vice President, Legal & Compliance, PharMEDium Services, LLC
Ruey Ju, Acting Senior Advisor for Compounding and Enforcement, CDER, FDA
Title II – Licensure of wholesale distributors and 3PL’s: Where does FDA stand, where do states stand, what about VAWD, and what can you to do about it?
Speakers will discuss the hurdles to licensure on the state and federal level for wholesalers and distributors, and will attempt to provide some answers.
Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General Counsel, Healthcare Distribution Management Association
Lori F. Hirsch, Managing Counsel, Merck & Co., Inc.
Moderated by Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC and Planning Committee Chair, Drug Quality and Security Act Conference
Concurrent Breakout Sessions
Title I – Enhanced Enforcement Activity in the Compounding World
In this breakout session, speakers will explore recent enforcement activities by FDA and states involving compounding pharmacies and outsourcing facilities – what FDA and states seem to consider when determining whether and how to pursue certain compounding practices – with at least one “real world” case study.
Hube Dodd, Founder, The Dodd Law Firm
David J. Horowitz, Partner, Hogan Lovells LLP
Rachael Pontikes, Partner, Reed Smith LLP
Jeffrey Steger, Senior Counsel for Complex Litigation, Consumer Protection Branch, US Department of Justice
Title II – Serialization and Enforcement
Panelists will focus on product identifiers and verification, FDA’s guidance delaying enforcement for one year, public meetings and FDA’s pilot project. Suspect packaging reporting will also be addressed.
Brent G. Eilefson, Vice President, Legal Affairs, Upsher-Smith Laboratories, LLC
Connie Jung, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, Office of Compliance, CDER, FDA
David Mason, AD Serialization ESO/Supply Chain, Sandoz
Chris Smith, Director, Federal Public Policy, National Association of Chain Drug Stores
Moderated by William Garvin, Shareholder, Buchanan Ingersoll & Rooney PC
Karla L. Palmer, Director, Hyman, Phelps & McNamara
Ilisa B.G. Bernstein, Deputy Director, Office of Compliance, CDER, FDA
William A. Garvin, Partner, Buchanan Ingersoll & Rooney PC
Abraham Gitterman, Associate, Arnold & Porter Kaye Scholer LLP
Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Rachael G. Pontikes, Partner, Reed Smith LLP
Christopher Pruitt, Associate Chief Counsel, OCC, FDA
Lee Rosebush, Partner, BakerHostetler
Continuing Legal Education
FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.
Location and Overnight Accommodations
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue, NW
Washington, DC 20005
The following hotels are within walking distance of the meeting location:
Sofitel Lafayette Square Hotel, 806 15th Street, NW
J.W. Marriott Washington, 1331 Pennsylvania Avenue NW
Grand Hyatt Washington, 1000 H Street NW
Willard Intercontinental, 1401 Pennsylvania Avenue NW
Driving, Parking, and Public Transportation
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.