Navigating the Labyrinth of DEA Regulations as a Prescribing Physician

Jonathan P. Novak

As a former DEA litigator, Jonathan Novak has seen first-hand the complexities of the Controlled Substance Actand the Code of Federal Regulations, and how a failure to fully understand the obligations and duties of a DEA Registrant can lead to unexpected trouble.  In this 7 week blog series, Mr. Novak will explore the intricacies of Prescribed Controlled Substances and the best practices any DEA-registered practitioner can implement in order to safely navigate the course between good patient care and compliance with the law.

The Controlled Substances Act

The Controlled Substances Act opens with the following Congressional statement:
“Many of the drugs included within [the Controlled Substances Act] have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.”
21 USC §801(1).  This opening line sets the tone for the entirety of the CSA: to protect the health and welfare of the people of the United States of America, it is hereby acknowledged that the majority of the controlled substances enumerated within have a legitimate medical purpose, and should be utilized as such.

Many practitioners today are afraid that by prescribing a patient certain controlled substances on the DEA’s radar; the practitioner will put themselves under the intense and often unfair scrutiny of the Drug Enforcement Administration.  Yet here, in its opening lines, the CSA establishes that its primary purpose is to protect the health and welfare of the people, and to acknowledge the benefits that many controlled substances offer.
No practitioner should be forced to choose between providing a patient with legitimate medical care or allowing a patient to suffer in order to protect herself.  However, every practitioner should always work with an understanding of the potential dangers patients face with controlled substances.

This blog will provide interpretation and analysis for the everyday practice of medicine, and for maintaining a tight ship in regards to providing care for your patients while simultaneously acting within the sometimes blurred lines of what DEA considers compliance.

Mr. Novak is a former attorney for the United States Department of Justice Drug Enforcement Administration.  He 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 contact 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.