Pharmaceutical Regulation and Compliance


Cadwalader’s White Collar Defense and Investigations group, which includes a former Chief of Staff of the Drug Enforcement Administration (DEA), has extensive experience advising and assisting clients on compliance with DEA requirements for controlled substance manufacture, distribution and dispensing, as well as the import and export of controlled substances.

The group has represented pharmaceutical manufacturers, distributors, retailers, pharmacies and other entities holding DEA licenses in civil, criminal and regulatory actions involving suspicious order monitoring, theft and loss, physical security, and pharmacy dispensing issues.  In addition, the group has regularly counseled clients on developing procedures and processes to comply with DEA regulations.

  • Represented a major generic drug manufacturer and distributor in defending a civil action by the DEA in federal court
  • Developed DEA compliance policies for a large national generic drug manufacturer
  • Represented several national wholesale distribution companies in litigation with the DEA in federal court and before an administrative law judge
  • Designed and implemented a DEA compliance plan for a large wholesale distribution company
  • Counseled a chemical manufacturer and broker relating to compliance with DEA domestic sales and export regulations
  • Counseled an international manufacturer regarding import and production quota issues
  • Represented a national retail chain pharmacy regarding dispensing practices in a DEA investigation
  • Advised a national retail chain pharmacy regarding its DEA anti-diversion compliance policies
  • Represented numerous employees of an international shipping company involved in the shipment of controlled substances in a federal criminal action



1 Attorneys

Avergun, Jodi L. Senior Counsel Washington
T. +1 202 862 2456