How to Survive a DEA Inspection Series - For Manufacturers and Distributors

Duration: 60 Minutes
The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
DEA Record Keeping
Instructor: Carlos M. Aquino
Product ID: 500003
Why Should you Attend:
How to Survive a DEA Inspection Series: For Manufacturers and Distributors Only” will focus on DEA record-keeping and security requirements and will prepare your company for that DEA inspection.

The presentation will cover all elements of a DEA inspection and all the stringent record-keeping and security requirements that are expected from manufacturers and distributors. It will provide you a better understanding of the inspection process.

Objectives of the Presentation:
The following areas are covered:
  • 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.
  • DMINISTRATIVE 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 the audit process is 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: biennial inventory, order forms, invoices, quota letters, ARCOS reports, thefts & drugs, power of attorney, and drug destructions.
  • SECURITY REQUIREMENTS – Covers stringent security requirements in order 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 can Benefit:
Corporate members and regulatory compliance personnel of DEA registered manufacturers and distributors who handle controlled substances.

$375
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carlos M. Aquino brings 36 years of experience of handling illicit and pharmaceutical controlled substances and regulated chemicals. His testimonial ability, both in federal and state courts, is proof of his investigative experience and skills. Carlos has 12 years of experience working for Philadelphia DEA Diversion Group, which is responsible for initiating prosecutions of those DEA registrants who violate the federal Controlled Substances Act or DEA regulations pertaining to handling these substances. This has included eight years as a Diversion Investigator and four years as a Group Supervisor. During his time at the DEA, he performed numerous regulatory inspections of manufacturers, distributors, importers/exporters, physicians, researchers, and pharmacies in order to determine their compliance with the federal laws and DEA regulations pertaining to controlled substances in Schedules II through V and regulated chemicals.
In addition to the above, Carlos has over 20 years of experience working for various law enforcement agencies including the Philadelphia Police. Carlos has a BA in Criminal Justice and has taught numerous courses during his time at the DEA.He is skilled in interpreting the Controlled Substances Act (CSA) and the Code of Federal Regulations (CFR), assisting the pharmaceutical industry with compliance, and preparing and submitting Drug Enforcement Administration (DEA) Forms 41, 104, 106, 222, 236, 486.
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