How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

Why Should You Attend:

Understanding DEA method of audit and their computation chart is important to prevent the diversion of purchased controlled substances and List I regulated chemical products used for manufacturing purpose.

The presentation gives participants a better understanding of how DEA will determine the unaccounted loss that could be interpreted as diversion of product. The presentation will provide a method for your facility to explain those unaccounted losses.

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.
• Actions by DEA - Discuss administrative/civil actions for failure to maintain proper record-keeping and the civil fine attached to negative findings.
• Computation Chart – Discuss in detail the elements of a DEA Computation Chart and what records will be needed to be presented to DEA personnel.
• 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.

Who Will Benefit:

Manufacturers registered with DEA to handle Schedules I through V controlled substance and List I regulated chemical products.

Carlos M Aquino
Consultant, PharmaDiversion, LLC

Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC . In January 2009, Carlos M. Aquino founded PharmaDiversion, LLC as a compliance consulting firm assisting DEA registrants, who handle controlled substances and regulated chemicals, with compliance of federal laws and regulations that are enforced by DEA through the Office of Diversion Control. This is done through a “Mock” audit and inspection equivalent to a DEA Diversion on-site inspection. The firm also provides in-service training on various areas pertaining to compliance with federal laws and DEA regulations for handling controlled substances.

Consultant Carlos M. Aquino brings 36 years of experience on handling illicit and pharmaceutical controlled substances and regulated chemicals. This includes 12 years with the Philadelphia DEA Diversion and 24 years with the Philadelphia Police Department. During the last 10 years, he was assigned to the Philadelphia DEA Task Force as a street supervisor, undercover agent and case agent investigating the distribution of illicit drugs and the diversion of pharmaceutical drugs.

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 List I regulated chemical products. Their goals are to detect, prevent, and investigate the diversion of controlled substances and List I regulated chemicals into the illicit market.

Understanding what steps are taken by DEA investigators, their methods of audit and computation is important for registrants to know. Generally, record-keeping violations are found through their computation chart used to determine any shortages (potential diversion) or overages (record-keeping errors) of controlled substances handled by the registrant.

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 dollars for failure to maintain Due Diligence for improperly handling these products.

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