How to Survive a DEA Audit - Webinar By MentorHealth January 10, 2013

Overview: This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these products, you will get a better understanding of what is required from a DEA registered manufacturer or distributor.

Why Should You Attend: When DEA Diversion personnel conducts an unannounced inspection to perform an audit on a premise that is registered as a manufacturer or distributor, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the registrant is not aware of what information they will need until they ask the registrant. In so many cases, the lack of record-keeping and security requirements will lead to some type of actions from an administrative violations to a civil action that may result in the firm paying thousands of dollars to settle any allegation that were uncovered by DEA personnel. This presentation will cover all the elements of a DEA inspection and all the record-keeping and security requirements that are expected during that unannounced inspection and will place you in a better situation to understand all the areas of the inspection. By following the outline, you can prepare your firm for that unannounced inspection.

Areas Covered in the Session:
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.
Federal Civil Actions - Provides a better understanding of the laws and regulations pertaining to the handling of these substances and what specific violations can result in civil actions against a DEA registrant.
Administrative Actions - Provides a better insight into the administrative actions that can result from a violation of federal laws and the regulations imposed on the handling of controlled substances and regulated chemicals.
DEA Computation Chart - Understanding how an audit is performed by a Diversion Group is very important for any DEA registrant when they arrive at their facility to conduct an unannounced audit and inspection.
Record-Keeping Requirements - Covers the records required by the Diversion Group 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 all the elements of effective security requirements in order to prevent the diversion of any controlled substance and regulated chemical.
DEA "Know Your Customers" Policy - Covers the responsibilities placed on a registrant when handling controlled substances and regulated chemicals.
Sending Documents to DEA - Learn the methodology and requirements for mailing documents to the local DEA office.

Who Will Benefit: All regulatory and quality assurance personnel of a manufacturer or distributor registered with DEA to handle controlled substances and regulated chemicals.
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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