How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

Why Should You Attend:

It is important to understand stringent DEA regulations required of a research lab. This training session will give attendees a better insight into steps to take to maintain required record-keeping and effective security in order to prevent illicit use or diversion of any controlled substance.

The presentation will provide effective record-keeping for purchasing and dispensing of controlled substances for testing or research purposes. Inventory, dispensing, usage and disposal records are part of the accountability process in order to comply with stringent DEA regulations.

The presentation is tailored for senior and mid-level management, scientists, chemists and other key employees responsible for required record-keeping, effective security and due diligence policies in order to comply with DEA regulations.

Areas Covered in the Webinar:

• Role of DEA – Familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.
• Civil Actions – Briefly describes the civil actions and fines imposed by the U.S Attorney’s office on a DEA registered research lab for failures to comply with DEA record-keeping and security regulations.
• Administrative Actions – Provides an insight into the administrative actions that results from violations of stringent DEA regulations imposed on a research lab facility.
• DEA Computation Chart – Understanding how the audit process performed by DEA 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: inventory, order forms, invoices, dispensing, usage and disposal in testing, thefts and losses, power of attorney, and drug destructions.
• Security Requirements – Covers stringent security requirements in order to prevent the diversion of any controlled substance.
• Sending Documents to DEA – Learn the methodology and requirements for mailing documents to the local DEA office.

Who Will Benefit:

• Senior and mid-level managers
• Scientists
• Chemists registered with DEA as a research facility in a facility doing research with controlled substances
• Research lab facility and researchers registered with DEA to handle Schedules I through V controlled substance for testing and research

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 on your competitor’s research lab facility and found several violations of stringent DEA regulations pertaining to the record-keeping and security of their 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 stringent DEA regulations.

Any violation of DEA regulations may lead DEA towards a civil action through 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 scheduled privileges or revocation of your DEA registration. In all cases, the violations leading towards civil fines are failures to maintain required records and lack of effective security. The actions may lead to more often inspections not only from DEA but other federal or state regulatory entities who communicate daily with DEA inspectors.

Knowing what is required of a DEA registered research facility will help the registrant prepare for that unannounced DEA inspection. Knowing stringent DEA record-keeping and security regulations is important and what is expected from your employees is essential in order to avoid the negative impact on the reputation of your business.

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