How to Survive a DEA Inspection – Compliance by
Prescribers and Pharmacists
James R. Schiffer RPh, Esq. &
Carlos Aquino
9:15 am - 10:15 am
Overview
Prescribers of controlled substances and the pharmacists who fill such prescriptions will familiarize
themselves with the federal laws and regulations pertaining to Schedules II though V controlled
substances that are prescribed, administered, or dispensed for legitimate medical purposes.
Learning Objectives
-
Review recent administrative and civil actions by the Drug Enforcement Administration (“DEA”)
through their Diversion Control Division (“Diversion”) personnel on prescribers and pharmacists
who prescribes, administers or dispense a controlled substance. -
Review the responsibility of a prescribing practitioner, who prescribes a controlled substance,
and a pharmacist who fills such prescription that is required to comply with federal laws and
regulations enforced by DEA Diversion personnel. -
Review the actions of DEA Diversion personnel when they proceed with an Order to Show Cause
against a DEA registration based on allegations that controlled substance prescriptions were
prescribed or dispensed without a legitimate medical purpose. -
Discuss the severity of DEA administrative actions when evaluating if a practitioner or a
pharmacy has been maintaining complete and accurate DEA required records and inventories of
controlled substances prescribed, administered or dispensed as a part of a patient treatment
plan. -
Recognize the steps to be taken by a practitioner or a pharmacist to follow federal laws and
regulations enforced by DEA pertaining to the prescribing and or dispensing of controlled
substance for a legitimate medical purpose. -
Explain the necessity of a prescriber or a pharmacist to maintain complete and accurate records,
especially electronic medical records with a full written explanation of a patient treatment plan
requiring the prescribing of a controlled substance.
Biographies
James R. Schiffer RPh, Esq.
Jim Schiffer's law practice draws on his many years of pharmacy and business experience. Mr. Schiffer has been named by the American Druggist trade magazine as one of the nation’s most influential pharmacy leaders for his work concerning the activities of Pharmacy Benefit Management companies, and he has received several national awards from pharmacy organizations for his work on behalf of the profession. Some 25 years after he became a pharmacist, Mr. Schiffer enrolled in law school; having completed his law degree in 2003. His practice is focused on representing businesses, trade associations and individuals (many of which are health care providers) in a variety of health care related matters, including government administrative investigations and administrative law proceedings, contract and business negotiations, and litigation matters.
Since 1987, Mr. Schiffer has served as an Adjunct Professor at Long Island University’s Arnold & Marie Schwartz College of Pharmacy and Health Sciences. Additionally, Mr. Schiffer regularly presents pharmacy continuing education programs through LIU’s Arnold & Marie Schwartz College of Pharmacy, the Pharmacists Society of the State of New York, the Garden State Pharmacy Owners, and the National Community Pharmacist Association at its Annual Convention and Trade Show. Mr. Schiffer is the recipient of the 2013 Bowl of Hygeia Award in New York, in recognition of his outstanding civic leadership as a pharmacist and has received awards from the National Community Pharmacists Association for his efforts on behalf of community pharmacy.
Carlos Aquino
In January 2009, Carlos Aquino retired from DEA Diversion and founded PharmaDiversion, LLC as a pharmaceutical consultant specializing in DEA controlled substance issues. He has 12 years with the Philadelphia Office of DEA and assigned to their Diversion Group (eight years a diversion investigator and four years as a group supervisor) and 24 years with the Philadelphia Police Department He retired with the rank of Police Sergeant. The last ten years he was assigned to the Philadelphia DEA Task Force as a street supervisor and an undercover agent conducting illicit and pharmaceutical drug investigations.
Carlos graduated from Temple University with a BA in Criminal Justice. He also completed the instructor’s Development Course, DEA Training Center in Quantico, VA.