Expert Details
DEA Regulatory Compliance
ID: 739977
Connecticut, USA
Expert's private sector experience includes two years as the Assistant Director of Compliance for a DEA registered pharmaceutical distributor. This position included directing the day-to-day operation of the Compliance Department, supervising and conducting due diligence investigations of customers as well as monitoring the Suspicious Order Monitoring (SOM) system. Additionally, he investigated independently owned pharmacies for compliance with US Department of Justice/DEA guidelines for dispensing controlled substances. Prior to this, Expert was a Diversion Group Supervisor at the Drug Enforcement Administration from October 2010 - January 2014. Here he was responsible for managing a diversion group of 11 employees including 6 diversion investigators, 4 registration program specialists, and an office assistant within DEA's largest field office. This position entailed the enforcement of the Controlled Substances Act, Code of Federal Regulations, part 1300 to end, as well as implementing DEA policies and procedures. This was accomplished through the direction and oversight of approximately 200 regulatory investigations annually, administrative investigations, due diligence investigations as well as civil complaint and criminal drug diversion cases resulting in successful prosecutions. Expert was also a Senior Diversion Investigator at the Drug Enforcement Administration from April 1987 - October 2010.
RDC 2018-2020 Directed the day-to-day operation of the DEA Compliance Department of a DEA registered distributor, supervised, and conducted due diligence investigations of customers, monitored the Suspicious Order Monitoring (SOM) system, among other responsibilities.
PCG 2014-2018 Conducted investigations of DEA registrants incorporating skills acquired through many years of experience as a DEA regulatory investigator and supervisor in order to fulfill clients' obligations for controlled substance due diligence in dispensing or distribution. Investigated independently owned pharmacies for compliance with US Department of Justice/DEA guidelines for dispensing controlled substances. Provided consultation services for clients such as hospital pharmacies, manufacturers, and wholesalers of controlled substances on DEA regulatory matters.
DEA GS 2010-2014 Group Supervisor responsible for managing a diversion group of 11 employees including 6 diversion investigators, 4 registration program specialists, and an office assistant within DEA's largest field office. This position entailed the enforcement of the Controlled Substances Act, Code of Federal Regulations, part 1300 to end, as well as implementing DEA policies and procedures. This was accomplished through the direction and oversight of approximately 200 regulatory investigations annually, administrative investigations, due diligence investigations as well as civil complaint and criminal drug diversion cases resulting in successful prosecutions. Supervised and provided oversight for the civil investigation of a DEA registered chemical exporter resulting in a civil fine of $420,000.00 which was the second highest civil fine in DEA history for that registrant class. Frequently assumed the position of Acting Diversion Program Manager which provides oversight for the Diversion Program throughout the New York Division. Additional responsibilities included establishing and maintaining liaison and relationships with various federal and state agencies such as the U.S. Attorney's Office, FBI, New York Medical and Pharmacy Boards, and New York Bureau of Narcotic Enforcement.
DEA DI 1987-2010 Senior Diversion Investigator responsible for conducting numerous DEA regulatory investigations, administrative investigations, due diligence investigations as well as civil complaint and criminal drug diversion cases which resulted in successful prosecutions. Civil prosecutions resulted in civil fines amounting to approximately $500,000.00. Criminal investigations resulted in numerous arrests. Administrative actions resulted in several hundred surrenders of DEA registrations and an Order to Show Cause proceeding resulting in revocation of DEA registration. Frequently assumed the position of Acting Group Supervisor for extended time periods up to several months. Established and maintained liaison and relationships with various federal, state, and local agencies, especially the U.S. Attorney's Office, New Haven, Connecticut, and the Connecticut Drug Control Division, Department of Consumer Protection.
Education
Year | Degree | Subject | Institution |
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Year: 1981 | Degree: MS | Subject: Criminal Justice | Institution: Northeastern University |
Year: 1980 | Degree: BS | Subject: Criminal Justice | Institution: Bryant College |
Work History
Years | Employer | Title | Department |
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Years: 2020 to Present | Employer: Undisclosed | Title: DEA Compliance/Diversion Consultant and DEA Opioid Litigation Consultant/Expert Witness | Department: |
Responsibilities:• Provides compliance consultation services in DEA regulatory matters for DEA registrant clients such as pharmaceutical manufacturers, distributors, and pharmacies.• Conducts investigations and/or audits of DEA registrants incorporating skills acquired through many years of experience as a DEA diversion investigator and supervisor, as well as private sector experience as an Assistant Director of Compliance and a senior DEA compliance consultant. • DEA Opioid litigation consultant and expert witness. • Provide consultation services to assist clients in fulfilling their obligations to conduct required controlled substance due diligence in dispensing or distribution of controlled substances, as well as providing expert opinion advice and reports to attorneys involved in controlled substance litigation. |
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Years | Employer | Title | Department |
Years: 2018 to 2020 | Employer: Rochester Drug Cooperative (RDC) | Title: Assistant Director of Compliance | Department: Compliance |
Responsibilities:• Directed and managed the controlled substance compliance department for a pharmaceutical wholesale distributor.• Reported directly to the CEO, board advisors, and legal counsel. • Directed the weekly Compliance Management Meeting and reported Compliance Department metrics to the CEO, board advisors, and legal counsel. • Determined and resolved DEA Red Flag issues presented by customers based on dispensing analyses and in conjunction with the company’s suspicious order monitoring (SOM) system. • Authority included decisions on whether to suspend or terminate the controlled substance ordering privileges of customers’ accounts. • Documented DEA Red Flag Determinations, reports, and data in the company’s central electronic filing system. • Supervised and conducted due diligence on site pharmacy visits and investigations. • Investigated flagged orders of interest. • Functioned as the main adjudicator for controlled substance purchasing increase requests. • Insured compliance with Title 21 of the Federal Code of Regulations, Part 1300 and DEA requirements pertaining to the handling of control substances. • Assisted in establishing and implementing due diligence and DEA compliance policy and standard operating procedures. |
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Years | Employer | Title | Department |
Years: 2014 to 2018 | Employer: Pharma Compliance Group (PCG) | Title: Senior Compliance/Diversion Consultant | Department: DEA Regulatory Compliance |
Responsibilities:• Reported directly to the President of the Company, focusing on investigations incorporating skills acquired through many years of experience as a DEA regulatory investigator and supervisor.• Conducted investigations to fulfill clients’ obligations for controlled substance due diligence in dispensing or distribution. • Investigated pharmacies for compliance with US Department of Justice/DEA guidelines for dispensing controlled substances. • Gathered facts based on interviews of supervising pharmacists. • Prepared objective and concise written reports of investigations. • Obtained evidence to support investigations. • Established and maintained professional working relationship with corporate elements and government oversight bodies. • Managed and prioritized workload with minimal supervision. • Provided consultation services for clients on DEA regulatory matters including review and evaluation of the SOM system for a pharmaceutical wholesaler and review of a manufacturer’s SOPs. |
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Years | Employer | Title | Department |
Years: 2010 to 2014 | Employer: Drug Enforcement Administration, Department of Justice (DEA) | Title: Diversion Investigator/Group Supervisor | Department: Diversion |
Responsibilities:• Managed a group of 11 DEA regulatory investigators and support staff.• Directed and provided oversight for 200 DEA regulatory, civil complaint, criminal, administrative, and due diligence investigations on an annual basis. • Established and maintained professional working relationships with various federal and state agencies such as the U.S. Attorney’s Office, FBI, New York Medical and Pharmacy Boards, and New York Bureau of Narcotic Enforcement. • Acted as Diversion Program Manager with oversight of regulatory and drug diversion matters for the State of New York. |
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Years | Employer | Title | Department |
Years: 1987 to 2010 | Employer: Drug Enforcement Administration, Department of Justice (DEA) | Title: Senior Diversion Investigator | Department: |
Responsibilities:• Conducted and led numerous DEA regulatory, civil complaint, criminal drug diversion, administrative, and due diligence investigations with positive results.• Gathered facts based on interviews of corporate officials and other witnesses. • Prepared objective and thorough written reports of investigations. • Obtained evidence to support investigations. • Ascertained if all regulatory and compliance standards were met as mandated by DEA. • Managed and prioritized workload with minimal supervision. • Received numerous awards for sustained outstanding performance. |
Government Experience
Years | Agency | Role | Description |
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Years: 1987 to 2014 | Agency: Department of Justice, Drug Enforcement Administration | Role: Diversion Investigator/Group Supervisor | Description: DEA GS 2010-2014 Group Supervisor responsible for managing a diversion group of 11 employees including 6 diversion investigators, 4 registration program specialists, and an office assistant within DEA's largest field office. This position entailed the enforcement of the Controlled Substances Act, Code of Federal Regulations, part 1300 to end, as well as implementing DEA policies and procedures. This was accomplished through the direction and oversight of approximately 200 regulatory investigations annually, administrative investigations, due diligence investigations as well as civil complaint and criminal drug diversion cases resulting in successful prosecutions. Supervised and provided oversight for the civil investigation of a DEA registered chemical exporter resulting in a civil fine of $420,000.00 which was the second highest civil fine in DEA history for that registrant class. Frequently assumed the position of Acting Diversion Program Manager which provides oversight for the Diversion Program throughout the New York Division. Additional responsibilities included establishing and maintaining liaison and relationships with various federal and state agencies such as the U.S. Attorney's Office, FBI, New York Medical and Pharmacy Boards, and New York Bureau of Narcotic Enforcement. DEA DI 1987-2010 Senior Diversion Investigator responsible for conducting numerous DEA regulatory investigations, administrative investigations, due diligence investigations as well as civil complaint and criminal drug diversion cases which resulted in successful prosecutions. Civil prosecutions resulted in civil fines amounting to approximately $500,000.00. Criminal investigations resulted in numerous arrests. Administrative actions resulted in several hundred surrenders of DEA registrations and an Order to Show Cause proceeding resulting in revocation of DEA registration. Frequently assumed the position of Acting Group Supervisor for extended time periods up to several months. Established and maintained liaison and relationships with various federal, state, and local agencies, especially the U.S. Attorney's Office, New Haven, Connecticut, and the Connecticut Drug Control Division, Department of Consumer Protection. |
Career Accomplishments
Awards / Recognition |
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Earned DEA performance awards for Dedication to Duty and Outstanding Contribution in 1995, 1998, 2000, 2003, and 2005 Earned a DEA performance award for Sustained Superior Performance in 2013. DEA Take Back Coordinator for the State of New York in 2011 Guest inspector for the Puerto Rico Diversion Offices (May 2011) |
Additional Experience
Expert Witness Experience |
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Expert has served as an expert witness and litigation consultant in the area of DEA regulations and compliance since 2020. He has experience reviewing thousands of records, authoring multiple expert reports, and testifying during multiple depositions. Expert provides consultation in DEA compliance and due diligence to DEA registrants. Expert has been deposed nine times and has experience testifying at trial. |
Training / Seminars |
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Numerous training courses in DEA, Washington, D.C.; FBI Academy and DEA Academy, Quantico, VA; Federal Law Enforcement Training Center, Glynco, GA. |