Controlled Substances 101: Introduction to the Fundamentals

May 28, 2019 9:00am – 12:30pm

Ronald Friedman
Karr Tuttle Campbell (Seattle, WA)

Daniel Kracov
Arnold & Porter Kaye Scholer (Washington, DC)

This workshop provides a basic overview of controlled substance regulations and will set the stage for the main conference by helping attendees thoroughly comprehend the structure and authority of the DEA and FDA in this area while walking through the evergreen and recent challenges that arise when working with controlled substances. Get the background information you need to flow seamlessly into the more in-depth discussions that will take place during the main conference. Topics include:
  • Introduction to the DEA and FDA: agency missions, authority and organizational structures
  • History of controlled substances regulations
  • Intersection between FDA and the DEA: how to work effectively with both agencies
  • Reviewing the drug scheduling process and effects on approval
    • How to de-schedule a drug or move to a different schedule
    • Applying for a schedule I license, including for research purposes
  • Registration requirements for a DEA number and DEA X number
  • Understanding abuse-deterrence, its current status, and its effect on the approval process
  • Responding to DEA audits, investigations, and enforcement actions
  • State licensing and the interplay with federal regulations
  • Advertising and promotion of controlled substances