Supply Chain Due Diligence for Manufacturers and Distributors: A Deep Dive into Satisfying DEA Diversion Obligations and Streamlining Suspicious Order Monitoring

March 14, 2023 2:15pm

Hunter G. DeKoninck
Attorney
Quarles & Brady LLP

Cory Kopitzke
Assistant General Counsel, Regulatory
Cardinal Health

Todd Prough, Ph.D
Controlled Substance Monitoring Program
AmerisourceBergen
Former Head of Pharmaceutical Investigations, DEA

Sarah Pechnick
Senior Director
Guidepost Solutions

  • Unpacking Suspicious Order Monitoring (SOMS) parameters:
    • What exactly constitutes a “suspicious order” (SO) and a “order received under suspicious circumstances” (ORUSC) and what does that mean in practical terms for distributors
  • Learning how to design and operate a system to identify SOs and ORUSCs
    • What information must you include when you report a suspicious order or ORUSC to DEA?
  • Understanding the benefits of an ERP system and knowing the legal and compliance aspects of utilizing technology to fulfill diversion obligations
  • Training employees to comply with SOMS requirements
  • Best practices for conducting virtual and onsite visits with prospective customers
    • Knowing where to search for relevant information and knowing the right questions to ask
    • Identifying the common and lesser-known red flags according to industry practice, legislative guidance and case law
    • Considering the unique due diligence for international supply chains