Administrative Actions Related to State License Issues
In 2017, DEA reported forty-six (46) administrative actions against practitioners, seeking to revoke existing registrations or deny pending applications for DEA registrations. Of those 46 administrative actions reported, a surprising 37 were related to a practitioner’s loss, lack, or suspension of his state license to handle controlled substances. In other words, an overwhelming 80% of the administrative actions brought by DEA are for state license issues.
What does this tell us? Historically, DEA enforcement actions against registrants focused on prescribing outside the usual course of professional practice or for other than a legitimate medical purpose. Operation Pill Nation 1 & 2 were state and federal, multi-agency operations focused on practitioners in Florida running opioid “pill mills” and, through deliberate indifference, willful ignorance, or profound disregard for the effects of diversion of controlled substances like oxycodone, who were participants in causing what has been labelled the Opioid Epidemic.
Yet in recent years, despite the stream of news coverage related to this Epidemic, DEA has inexplicably shifted its enforcement focus almost exclusively to state licensure issues with practitioners. Perhaps a lack of funding for investigations, disinterest in revocations without the possibility of civil penalties for pharmaceutical corporations, or depleted manpower can explain the current trend. One thing is for certain: it is far easier for DEA to “passively revoke” a registration under a state licensure claim than to pursue an investigation into bad prescribing practices.
The reason state license cases at DEA are so easy to prosecute relates back to the Controlled Substances Act, which states that a DEA registration can be suspended or revoked upon a finding that the registrant “has had his State license or registration suspended, revoked, or denied by competent State authority.” In the eyes of DEA, a valid state license is considered a prerequisite to obtaining and maintaining a DEA registration.
This presents several pitfalls for practitioners. Although the statute allows for the suspension or revocation of a DEA registrant’s registration, DEA has long held that lack of a state license is ground for revocation, not suspension. The lack of a state license may take several forms: the fact that a state license is merely suspended for a defined period of time is no defense, and revocation will follow. Similarly, in states where a practitioner is required to obtain both a state medical license and a state controlled substance license, the lack of either license is enough, on its own, to justify revocation of your registration.
DEA field offices are not always in direct communication with state medical boards, therefore DEA may not immediately find out when a practitioner has lost his state license. As such, it may be tempting for a registrant not to inform DEA of the loss of a state license in the hopes that the license will be reinstated prior to DEA finding out. However, as agency case law reveals, DEA expects compliance with and respect of its authority, and will pursue a practitioner who steps even slightly out of line, including a failure to disclose the loss of a state license.
It’s important to note, DEA can and will revoke a registration on state license grounds without a hearing on the matter. This is similar in scope to a “strict liability” type of statute under the CSA and the CFR, and provides DEA with an easy, passive, nearly effortless “win.” Perhaps this explains the overwhelming number of state license cases brought by the Administration in the last few years.
As a practice, every practitioner should maintain a list of all of their state and federal registrations and keep all registrations up to date. A missed deadline due to a forgetful assistant or a change in staffing will serve as no defense in a DEA state license action. In the event that you lose your state license, on any grounds, you should inform your local DEA office immediately, and offer to turn over your current DEA registration – remember that prescribing without a state license could potentially amount to a criminal violation.
In the event that DEA initiates administrative proceedings against your registration for lack of a state license, the simplest truth is: you will almost certainly lose your DEA registration. However, there are surefire ways to begin the process of reinstating your state licensure and applying for a new DEA registration as soon as practicable.
Mr. Novak is a former attorney for the United States Department of Justice Drug Enforcement Administration. Jonathan is now working nationwide representing public entities, including counties, cities, and Native American tribes, in litigation against manufacturers and distributors of opioid controlled substances, as well as providing education and legal guidance on state and federal controlled substance regulations. If you have any questions or concerns regarding regulatory compliance, state or federal enforcement action on your controlled substance or pharmacy registration, or if you represent a public entity interested in learning more about potential litigation against opioid manufacturers and distributors, please contract Jonathan directly ([email protected] ).
This blog is for informational purposes only and meant to provide general insight and commentary; it is not meant to convey specific legal advice. By using this blog site you understand that there is no attorney client relationship of any kind. The information contained in this blog is opinion based and should not be used as a substitute for skilled legal advice from a licensed professional attorney in your state.