New Developments in the Drug Supply Chain Security Act

The Drug Supply Chain Security Act outlines critical steps to building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will have new and significant responsibilities under the Act. The development of the system will be phased in with new requirements over a 10-year period. However, several of these provisions will begin in 2015.  In this program, Angelo Cifaldi and Satish Poondi of Wilentz, Goldman, and Spitzer, P.A., discuss these new provisions and the legal impact they will have on the pharmaceutical industry and the individual pharmacy.  

Learning Objectives: 

I.    Grasp the history of the Act and  the new requirements imposed by the Act 

II.   Define key terms, including “pedigree,” “Drug Supply Chain Integrity,” and “product tracing”

III.  Comprehend the gray market that has emerged and its meaning in the legal and ethical contexts 

IV.  Identify good practices to prevent legal issues in the purchase of medications 

V.   Recognize the clinical and economic impact of drug shortages

VI.  Understand the impact of the Act as it relates to the pharmacy’s relationship with vendors, patients, and third party insurances