June 18 & 19, 2013 — National Harbor, Maryland
The Drug Enforcement Administration (DEA) hosted a two-day Manufacturers/Importers/Exporters Conference on June 18 and 19, 2013. 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 the 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, ARCOS reporting, import/export permits and import/export declarations were discussed.
Cathy Gallagher, Section Chief, Liaison & Policy Section, DEA HQ, served as the Master of Ceremonies. Ms. Gallagher opened the conference by welcoming everyone to National Harbor, Maryland and providing some administrative announcements.
Alan Santos, Associate Deputy Assistant Administrator, DEA HQ, gave a presentation titled Drug and Chemical Trends which detailed the diversion trends that are emerging in the United States.
James Arnold, Unit Chief, Regulatory Unit, DEA HQ, spoke on Registrant Responsibilities – Effective Controls Against Diversion. Mr. Arnold's presentation provided information about the background of current drug control legislation and the responsibilities that DEA registrants have in knowing their customers and reporting suspicious orders.
Kyle Wright, Unit Chief, Targeting & Analysis Unit, DEA HQ presented an overview of the ARCOS Reporting Requirements. His presentation detailed ARCOS reporting requirements and proper procedures for ARCOS error corrections.
Minh Dang, Drug Science Specialist, Quotas and U.N. Reporting Unit, DEA HQ provided information on two topics during the afternoon session:
Terrence Boos, Acting Unit Chief, Drug & Chemical Evaluation Section, DEA HQ, ended the first day with a presentation on Drug and Chemical Scheduling Actions. Dr. Boos discussed the types of scheduling actions and illustrated a general scheduling flowchart.
Jorge Jimenez, Unit Chief, ODRR, DEA HQ, began the second day of the conference with a presentation titled Inventories, Records, and Reports. He provided useful information about how and when to conduct inventories, what records are required and the retention period, and what reports are required.
Mark Via, Technical Information Specialist, Import/Export Unit, DEA HQ provided information on two topics during the morning session:
Gregory Kavanagh, Drug Science Specialist, Quotas and U.N. Reporting Unit, DEA HQ ended the morning session with a presentation about "Year-End Reporting." He provided data about why year-end reporting is required, deadline dates each year, and what the data is used for.
After lunch, the attendees were able to participate in two breakout sessions which allowed them the opportunity to ask questions and participate in discussions. The two breakout session topics were Quotas/U.N. Reporting and Import/Export.
Dedra Curteman, Senior Attorney, Diversion and Regulatory Litigation Section, gave a presentation on legal issues. She talked about the CSA, effective controls, responsibilities under the law, security, and potential results for violations.
The conference concluded with a short Q&A session and closing remarks by Ms. Gallagher.