How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

Why Should You Attend:

Understanding DEA record-keeping and security requirements will help with preparing your company for that DEA inspection. Knowing DEA record-keeping and security regulations is important and what to expect from your employees is essential to avoid the negative impacts on the reputation of your company.

The presentation will cover elements of a DEA inspection and all the stringent record-keeping and security requirements that are expected from a manufacturer. It will provide you with a better understanding of the inspection process. Knowing what is required of a DEA registered Manufacturer will help in preparing for that unannounced DEA inspection.

Areas Covered in the Webinar:

• DEA office of diversion control – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.
• Civil actions – Provides a better understanding of DEA regulations pertaining to the handling of those substances and what specific violations can result in civil actions against a DEA registrant.
• Administrative actions – Provides an insight into the administrative actions that results from violations of stringent DEA regulations imposed on manufacturers and distributors of controlled substances.
• DEA computation chart – Understanding how DEA performs the audit process is important in order for the registrant to know what is expected from employees.
• Record-keeping requirements – Covers records required by DEA during any unannounced inspection. Records include: biennial inventory, order forms, invoices, quota letters, ARCOS reports, thefts & drugs, power of attorney, and drug destructions.
• Security requirements – Covers stringent security requirements to prevent the diversion of any controlled substance.
• DEA “know your customers” policy – Covers responsibilities placed on DEA registrant when distributing controlled substances.
• Sending documents to DEA – Learn the methodology and requirements for mailing documents to the local DEA office.

Who Will Benefit:

Corporate members and regulatory compliance personnel of DEA registered manufacturers of controlled substances.

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:

DEA performed an unannounced inspection of your manufacturing facility and found several violations of stringent DEA regulations pertaining to the record-keeping and security of your handling of controlled substances. The question you need to ask yourself is “How can I prepare my facility?” Every inspection brings a new challenge depending on the DEA inspector. The focus should be compliance with DEA regulations.

Any violation of DEA regulations may lead DEA towards a civil action through the Civil Division of the U.S. Attorney’s Office. Fines range from $10,000 to $25,000 per violation of stringent DEA regulations which may add up to a substantial fine. Violations may lead to administrative actions including modification of your drug schedule privileges or revocation of your DEA registration. In all cases, the violations leading towards civil fines are failures to maintain complete and accurate records and the lack of security of controlled substances. These DEA actions may lead to more often inspections not only from DEA but other federal or state regulatory entities who communicate daily with DEA inspectors.

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