I know it can be said about many areas of the law; however, the statue, regulations, and administrative caselaw governing controlled substances is truly a different animal. I frequently get calls from attorneys seeking advice on matters involving Drug Enforcement Administration investigations. Many have little to no experience with such matters. My first (and perhaps most important) reminder is that it is the Drug Enforcement Administration, not Drug Enforcement Agency – a huge pet peeve for current and former DEA employees.
Beyond that admonishment, our conversations usually involve an in-depth discussion of how DEA investigations and administrative proceedings are very different from what attorneys normally encounter with federal investigations. Not bad, just different.
This is on full display with the hearings involving the rescheduling of marijuana. If you haven’t done so, I would encourage you to read the pleadings and watch the videos.
Conversations with DEA registrants tend to go the same way, especially with pharmacy owners and pharmacists. The concepts of corresponding responsibility and “red flags” remain widely misunderstood (for a refresher course on the topic, read this, this, this, and this). As DEA has stated in its administrative caselaw, and as my friends at Hyman, Phelps & McNamara P.C. reminded us recently, you don’t need actual diversion of controlled substances (i.e., use for other than a legitimate medical purpose) to run afoul of DEA’s requirements and potentially lose your registration.
Failure to detect and resolve red flags is sufficient to demonstrate a failure to exercise “corresponding responsibility” regardless of whether the prescriptions were issued for a legitimate medical purpose. Moreover, post-hoc justifications will not save your registration. Scrutinizing prescriptions before they are dispensed (with proper documentation) and routinely reviewing your pharmacy’s dispensing data will go a long way to ensuring your pharmacy keeps its DEA registration and is able to service patients in your community.
Visit https://cssolutionsusa.com/ and learn how you can confidently identify and investigate red flags to mitigate your compliance risks.