Understanding the New Paradigms in Pharmacy Compliance with Proper Drug Distribution
This will cover the FDA Drug Supply Security Act
At the completion of the activity, the participant will be able to:
List the components of the new FDA regulations regarding pharmaceutical product integrity
Identify the problems associated with counterfeit pharmaceuticals in the marketplace.
Describe the increase of criminal diversion and hijacking of pharmaceuticals and medical supplies throughout the drug distribution process.
List the sources of product integrity confirmation by use of various pharmaceutical manufacturers and distributors web tools.
Identify the differences between the old process of confirming pharmaceutical integrity under the "pedigree" concept versus the new FDA "Track and Trace" procedures.
Jim Schiffer’s law practice draws on his many years of pharmacy and business experience. Mr. Schiffer has been named by American Druggist 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 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.
His experience includes representing clients in audits, investigations and proceedings before the U.S. Food and Drug Administration; Drug Enforcement Administration; the Centers for Medicare and Medicaid Services; the New York State Attorney General’s Office Medicaid Fraud Control Unit; various agencies within the New York State Department of Health, including the Office of Health Insurance Programs, the Bureau of Narcotic Enforcement, and the New York Office of the Medicaid Inspector General; the New York Board of Pharmacy’s Office of Professional Discipline; the New Jersey Board of Pharmacy; the New Jersey Department of Banking and Insurance; and the New Jersey Office of the Medicaid Fraud Control Unit. Mr. Schiffer similarly represents pharmacy clients with respect to audits and investigations conducted by and on behalf of commercial insurers and their associated pharmacy benefit managers. Mr. Schiffer also regularly advises clients in connection with negotiating and drafting stockholders’ agreements, stock purchase agreements, and asset purchase agreements.
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.
ACPE UAN # 0042-0000-21-037-H03-P
- 1.00 ACPEThe Arnold & Marie Schwartz College of Pharmacy and Health Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.