The Drug Enforcement Administration (DEA) regulates manufacturers, distributors, pharmacies, and practitioners authorized to handle prescription drug controlled substances. The revocation of an existing DEA registration, or the denial of an application for registration, can significantly impact the livelihood or business of an affected party. Under the Controlled Substances Act (CSA) and DEA’s implementing regulations, such parties are entitled to a full administrative hearing before DEA’s administrative law judges.
Revocation and denial hearings are complex and require detailed knowledge of DEA hearing procedures, as well as agency interpretation of the CSA and the DEA’s implementing regulations. This course, taught by Karla Palmer of Hyman, Phelps & McNamara P.C., will present a general background of the Controlled Substances Act and its implementing regulations, and recent legislation affecting DEA registrants such as the SUPPORT Act, enacted in late 2018, and new proposed rules for suspicious orders. The program will also provide an overview of the hearing process, an introduction to the statutory basis for revocation or denial, and a discussion of recent “hot” issues in DEA administrative decisions. Finally, the presenter will address recent DEA administrative actions, with a focus on the ongoing opioid crisis and the DEA’s increased focus on the diversion of opioid medications.
- Review the basics of the DEA and CSA, including 2018 amendments to the CSA (SUPPORT Act), as well as the DEA’s healing process and procedures
- Identify what steps to take when facing a DEA administrative action (order to show cause or immediate suspension order)
- Apply relevant statutory and regulatory provisions, as well as agency precedent contained in prior decisions, to your matter