While DEA audits are routine, they can lead to criminal prosecution and administrative action against your DEA registration if violations of the Controlled Substances Act are found. Therefore, we advise DEA registrants who are subject to a DEA audit, or are aware of a DEA investigation into their practice, to contact our attorneys immediately. We can advise you of your rights and how to proceed, and represent you before the DEA during a DEA audit.
The DEA frequently conducts investigations and audits to determine compliance with the Controlled Substances Act (CSA). DEA audits, or inspections, can be conducted for a variety of reasons:
Practitioners are generally inspected once every three years; however, it may be more frequent if they prescribe buprenorphine and/or have a Drug Addiction Treatment Act of 2000 waiver. Narcotic treatment programs, distributors and other non-practitioner DEA registrants can expect a DEA inspection once every five years.
Unlike searches for criminal proceedings, the DEA does not require a search warrant to conduct a DEA inspection to determine compliance with the CSA. However, if the DEA is participating in a criminal investigation with other agencies, they must have a search warrant to search a practice/clinic. DEA inspections are conducted by DEA diversion investigators who are assigned to various field offices across the United States and are generally part of the DEA’s Diversion Control Program. A DEA audit begins when a DEA Form 82 (Notice of Inspection of Controlled Premises) or an administrative inspection warrant is presented to a DEA registrant prior to the inspection.
If a DEA Form 82 is presented, the DEA registrant must give informed consent before the DEA audit or inspection may begin. Informed consent is a written statement by the registrant stating that he or she has been informed of the constitutional right not to have an administrative inspection, that anything of incriminating nature can be used against the registrant in a criminal prosecution, and that he or she voluntarily consents.
In some cases, the DEA does not need informed consent to conduct a DEA inspection without an administrative search warrant. An administrative warrant is not required for establishments applying for initial DEA registration, for inspection of books and records pursuant to an administrative subpoena issued by the DEA’s subpoena power, or for administrative inspections where there is an imminent danger to the public health or safety and where the opportunity to apply for a warrant is lacking.
If the DEA registrant refuses to give informed consent to the DEA audit, the DEA must obtain an administrative inspection warrant from the U.S. Federal District Court. Unlike a search warrant, an administrative inspection warrant does not require the DEA to show probable cause. Rather, to obtain an administrative search warrant, the DEA is required to describe the nature and extent of the inspection and any items that they wish to seize. Courts routinely grant administrative search warrants.
If the DEA presents an administrative search warrant to conduct a DEA audit or inspection, the registrant must comply. Refusal to comply is grounds for arrest. If you receive a DEA administrative search warrant, you should contact our attorneys immediately. Our attorneys are experienced in handling DEA investigations and enforcement actions and can give you immediate advice to help protect you, your practice, and your DEA registration.
There are several reasons why a DEA registrant might refuse to give informed consent even though the DEA will likely obtain an administrative search warrant. First, the DEA conducts inspections without warning, and the DEA registrant may wish to contact an attorney before the search or DEA audit begins. We strongly advise that registrants who receive an administrative subpoena or DEA Form 82 contact our attorneys immediately. We can help determine a registrant should give informed consent for a DEA inspection. If the DEA presents an administrative search warrant and the DEA investigation is already underway, our attorneys can help ensure that the DEA does not exceed the scope of the warrant. Additionally, we can assist in identifying areas of concern and help present your practice in the best possible light before the DEA.
An administrative search warrant does not give the DEA authority to inspect everything within the practice. The statute limits what the DEA can inspect; however, a recent court decision expanded the scope to include patient records. As of the time of writing, the case is pending appeal; therefore, it is unclear whether the DEA has the authority to inspect patient records under an administrative search warrant. The DEA may attempt to interview you or your staff. Any information offered to the DEA may be used against you in an administrative or criminal proceeding. Therefore, we strongly advise that you contact our attorneys before speaking with the DEA. We can help ensure that your rights are protected and that the DEA does not exceed the scope of their search warrant or their powers under a DEA Form 82 inspection.
Following a DEA audit, if noncompliance is found, the DEA will issue a DEA audit report detailing issues considered to be noncompliant with the Controlled Substances Act (CSA). If noncompliance with the CSA is found, the DEA may refer the matter to the Department of Justice (DOJ) for criminal prosecution and/or make take administrative action against the practitioner’s or facility’s DEA registration.
Our attorneys are experienced in defending DEA registrants both during DEA investigations and in subsequent DEA actions. We are dedicated to helping practitioners, pharmacies, distributors, and other registrants protect their DEA registration. Our goal is not only to protect the DEA registration of our clients, but also to protect their other professional licenses, their career, and their reputation from damage that DEA investigations and allegations of noncompliance can cause. We know you work hard for your license and your career, and we will work hard to help you protect it.