“Understanding the New Paradigms in Pharmacy Compliance with Proper Drug Distribution” Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) North Central Chapter New Jersey Society of Health-System Pharmacists April 13, 2016 Overlook Hospital Atlantic Health Systems Summit, New Jersey Presented by: James R. Schiffer, R.Ph., Esq. Allegaert Berger & Vogel LLP New York City, New York

NOTICE AND DISCLAIMER: The following presentation was prepared by the FDA and originally presented by the FDA at the National Association of Chain Drug Stores Meeting of August 2014 This continuing education program is not intended to provide legal advice but is intended to help share an understanding of the new federal regulations regarding the legal and proper distribution of prescription drugs through the United States marketplace.

The requirements to maintain records of pharmaceuticals purchased has been shifted from state requirements to a federal initiative. The concept of “Pedigrees” has been eliminated and replaced by a new term, “Track & Trace”. Requirements for maintaining such purchase records is being phased in over a number of years. Suppliers must already comply with this federal statute while pharmacies and their managers are being slowly introduced into this new process of record keeping.

Disclosures I have no financial relationship to disclose regarding the content of this presentation.

Pharmacist and Technician Learning Objectives Summarize the components of the new FDA regulations regarding pharmaceutical product integrity Identify the problems associated with counterfeit pharmaceuticals in the marketplace. Recognize the increase of criminal diversion and hijacking of pharmaceuticals and medical supplies throughout the drug distribution process. Recognize 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.

Question #1 The Drug Quality Security Act -Section II (“DQSA”) is intended to assure the legitimacy of the drug supply chain in the United States. Which of the following products are covered under the DQSA? a)Brand Name Prescription Pharmaceuticals b)Over the Counter Drugs c)Sick Room Supplies such as Blood Glucose Strips d)Nearly all Prescription Pharmaceuticals (with a few exceptions) e)None of the Above

Question #2 The process of confirming the source of pharmaceutical product under the provisions of the DQSA replaces what patchwork of prior integrity efforts? a)State laws and or regulations demanding “pedigree information” on the prior sales/returns transactions which the pharmaceutical had been transferred between b)Wholesaler voluntary tracing records to confirm the legitimacy of the pharmaceutical product being sold/acquired. c)Pharmacy benefit managers/pharmaceutical insurers requirements for documentation of authenticity of the pharmaceutical product being used for dispensed prescriptions. d)Food and Drug Administration criminal investigations of counterfeit pharmaceuticals e)All of the Above

Question #3 Which group of health care professionals are currently exempt from the provisions of the Drug Quality Security Act –Section II tracking requirements? a)Hospital based in patient pharmacies b)Mail order Pharmacies c)Retail Pharmacies d)Licensed health care practitioners authorized to prescribe or administer medications under state law or other licensed individuals under such supervision of such licensed health care practitioners e)None of the above

Question #4 Which of the following are included under the DQSA definition of Dispensers: a)Retail Pharmacies b)Chain Pharmacies (under common ownership/control that are not a wholesaler) c)Hospital Pharmacy d)Any other person authorize by law to dispense or administer Prescription Drugs (and affiliated warehouses or distribution centers of such persons) e)All of the above are included

Question #5 Which of the following pharmaceuticals has NOT been subject to verifieable and reported counterfeiting circulated for distribution in the United States? a)Neupogen b)Lipitor c)Serostim d)Viagra e)Harvoni