September 23 & 24, 2015 — National Harbor, Maryland
The Drug Enforcement Administration (DEA) hosted a Manufacturer/Importer/Exporter Conference on September 23-24, 2015. The conference was held at the Gaylord National Resort and Convention Center, National Harbor, Maryland. The purpose of this conference was to provide a forum to present federal laws and regulations that affect pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices to prevent diversion while minimizing the impact on legitimate commerce. In addition, topics such as quotas, year-end reporting, Automation of Reports and Consolidated Orders System (ARCOS) reporting, import/export permits and declarations were discussed.
Ruth A. Carter, Section Chief, Liaison & Policy Section, DEA HQ, served as the Master of Ceremonies. Ms. Carter opened the conference by welcoming everyone to National Harbor, Maryland and providing some administrative announcements.
Tom Prevoznik, Unit Chief, Liaison Unit, DEA HQ, spoke on "Manufacturer Trends and Updates". Mr. Prevoznik's presentation provided information regarding DEA's Role and Response to the National Pharmaceutical Epidemic, and a National Distributor Initiative pertaining to suspicious orders.
Kristin Fitzgerald, Office of Resource Conservation and Recovery, U.S. Environmental Protection Agency, talked on "Understanding How EPA's New Proposed Rule for the Management of Hazardous Waste Pharmaceuticals Will Affect Healthcare Facilities and Reverse Distributors".
Ed McGinley, Executive Director, National Association of Boards of Pharmacy presented on the "Stakeholder Consensus Report".
Captain Valerie Jensen, RPH, Associate Director, FDA, CDER, Drug Shortage Staff, spoke on "Drug Shortages and Role of FDA and Manufacturers".
Stacy Harper-Avilla, Unit Chief, Quota & UN Reporting Section, DEA HQ, presented on "Quota Overview Drug and Chemical".
Dedra Curteman, Senior Attorney, Office of Chief Counsel, DEA HQ, presented on "Administrative Diversion Cases".
Gregg Sullivan, Assistant United States Attorney, Chattanooga, Tennessee talked on "Criminal Diversion Cases".
Les Hollie, Assistant Inspector General, HHS/OIG/OI, spoke on "Pharmaceutical Diversion in Medicare/Medicaid".
Cathy Gallagher, Section Chief, Regulatory Section, DEA HQ and Mark Via, Technical Information Specialist, DEA HQ, spoke on "Import and Export Drugs and Chemicals".
Christine Sannerud, Section Chief, Quota & UN Reporting Section, DEA HQ and Stacy Harper-Avilla, Unit Chief, Quota & UN Reporting Section, DEA HQ presented an overview on "Quota Application for Drug and Chemicals, and Year End Reporting".
Kyle Wright, Unit Chief, Pharmaceutical Investigations Section, DEA HQ and Alan Drumheller, Unit Chief, ARCOS, DEA HQ, presented an overview of the "Automation of Reports and Consolidated Orders System (ARCOS)".
Claire Brennan, Staff Coordinator, Synthetic Drugs & Chemical Section, DEA HQ and Tony Guzman, Staff Coordinator, Synthetic Drugs & Chemical Section, DEA HQ, discussed "Chemical Manufacturers, Importers and Exporters".
Cathy Gallagher, Section Chief, Regulatory Section, DEA HQ and Michele Herron, Unit Chief, spoke on "Regulatory Matters".
Ruth Carter, Section Chief, Liaison & Policy Section and Erika Gehrmann, Section Chief, Registration Section, DEA HQ, facilitated a session on "General Questions".
Both days of the conference concluded with a short Q&A session and closing remarks by Ms. Carter.