WORKSHOP A — Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling

Jun 14, 2021 9:00am – 12:00pm

Tom Firestone
Partner
Baker & McKenzie LLP

Seth A. Mailhot
Partner
Husch Blackwell LLP (Washington, DC)

Get the background information you need to seamlessly  follow and engage in the more in-depth discussions that will take place during the main conference.

  • An introduction to the DEA and FDA: agency missions and organizational structures relative to controlled substance regulation
  • Understanding the intersection between FDA and the DEA jurisdiction over controlled substances
  • Defining a “controlled substance
  • Understanding drug scheduling and the potential for abuse, safety, addictive potential and whether it has any legitimate medical applications
  • Considering the process to obtain approval from the DEA for schedule I-V controlled substances
  • Understanding abuse-deterrence, its current status, and its effect on the approval process
  • Working effectively with the DEA and FDA
  • Exploring the interplay between state licensing and federal regulations as they impact the discovery, development and marketing of controlled substances.
  • Responding to DEA enforcement actions