DEA, Your Registration and How to Lose It

Why Should You Attend:

Understanding the DEA "Know Your Customer Policy" is important and the steps suggested in this training will give you a better insight as to what steps should be taken to prevent the illicit use or diversion of any controlled substance and regulated chemical products purchased by a customer.

What the presentation does is that it gives participants a better understanding of how the suggested regulatory compliance should look like in order to identify those customer orders that should be classified as suspicious in nature and what actions they can take to prevent the diversion of their products by their customers.

This training will cover several recommendations to improve the Corporate Due Diligence when distributing Schedules I through V controlled substances and regulated chemicals to their customers and what steps can be taken to detect and prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered Manufacturer or Distributor when a customer’s order becomes an order of interest or identified as a suspicious order.

Areas Covered in the Webinar:

• DEA OFFICE OF DIVERSION CONTROL – This section will familiarize you with the authority given to the Diversion Group when enforcing the laws and regulations pertaining to controlled substances and regulated chemicals.
• DEA REQUIRED RECORDS – This section covers the requirement differences between the DEA Field Offices and their Headquarter requirements.
• DUE DILIGENCE – This section provides some suggestions on improving the regulatory compliance of a firm handling Schedules II through V controlled substances and regulated chemical products. It also covers the registrant’s responsibilities to assure that customers are compliant with DEA regulations.
• DEA "KNOW YOUR CUSTOMER POLICY" – This section provides a better understanding of what DEA requires from registrants in order to maintain an effective suspicious ordering process and steps for compliance with regulations.
• DEA RECORDKEEPING REQUIREMENTS – This section covers the required records to be maintained in order to comply with DEA regulations. Records include receiving/shipping order forms and invoices, inventories, ARCOS, Quotas, drug destructions, and theft/loss reports.
• CUSTOMER FILES RECORDS – This section provides suggestions on what information should be in a Customer’s File in order to maintain the necessary documentation especially for a customer whose orders have been identified as an Order of Interest or a Suspicious Order.

Who Will Benefit:

Target audience for this training are Manufacturers and Distributors registered with DEA to handle Schedules II through V controlled substance.

The presentation is tailored for corporate leaders, their regulatory compliance and key employees responsible for required records and security.

• Regulatory Affairs/ Compliance
• Quality Assurance
• Documentation
• Senior Management
• In-house Counsel

Carlos M Aquino
Consultant, PharmaDiversion, LLC

In January 2009, Carlos M. Aquino retired from the DEA Diversion and founded PharmaDiversion, LLC as a pharmaceutical consultant specializing in DEA controlled substance issues. His other work experience in the field includes 12 years with the Philadelphia Office of DEA and assigned to their diversion group (eight years as a diversion investigator and four years as a group supervisor).

Mr. Aquino has also served 24 years with the Philadelphia Police Department, after which he retired with the rank of police sergeant. During his tenure with them, he served the last ten years assigned to the Philadelphia DEA task force as a street supervisor and an undercover agent conducting illicit and pharmaceutical drug investigations.

Mr. Aquino graduated from Temple University with a BA in Criminal Justice and has also done an instructor’s development course at the DEA Training Center, Quantico, VA.

Topic Background:

The Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion) is responsible for the enforcing federal laws and DEA regulations pertaining to the handling of controlled substances and regulated chemicals in order to detect and prevent the diversion of controlled substances and regulated chemicals into the illicit market.

The DEA "Know Your Customer Policy" is the Due Diligence that is required from DEA registered Manufacturers and Distributors handling Schedules I through V controlled substances and regulated chemical products in order to detect and prevent diversion of these products into the illicit market.

Since the passage of the Controlled Substances Act, more emphasis has been placed on Manufacturers and Distributors, registered with DEA, to design and operate a system that will disclose suspicious orders of controlled substances and regulated chemical products by their customers.

The responsibilities by DEA registered Manufacturers and Distributors is to assure DEA that all purchased and dispensed controlled substances and regulated chemical products are done for legitimate use. The responsibility is not only for their customer but their customer’s customers.

Any violation of federal laws and DEA regulations may lead towards a civil action through the U.S. Attorney’s Office which may result in fines ranging from $10,000 to $25,000 for each violation. It can lead to an administrative action including the modification of the drug schedules or revocation of a DEA registration. In many cases, the civil fines may amount in millions of dollar for the failure to maintain Due Diligence for improperly handling these products.

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