The Controlled Substances Act of 1970 authorizes the Drug Enforcement Administration (DEA) to deny, suspend, or revoke a DEA registration. However, the Attorney General may limit discipline to the controlled substance or chemical list that is the subject of the discipline. A DEA registration is required for any health care professional who prescribes or dispenses controlled substances.
The DEA’s disciplinary process works as follows. First, the DEA will serve an Order to Show Cause or an Immediate Suspension Order upon its registrant, such as a physician, nurse practitioner, dentist or pharmacist. The order will contain a statement of facts, the legal reason for the discipline, and a time and place for a hearing on the matter. Despite having a hearing date provided, the registrant still must file a formal request for a hearing within 30 days or they will have waived their right to present their evidence and their case is sent to the DEA Administrator for the final decision. If the DEA does not receive a formal request for hearing, the outcome is usually revocation of the registration.
If a hearing is requested, the case is assigned to a federal administrative law judge (ALJ). The ALJ’s first step is typically to require both parties to file prehearing statements that address the issues that will be raised at hearing and the documents and witnesses that will be presented at hearing. The prehearing statements are formal pleadings drafted in accordance with the federal Administrative Procedure Act. These statements are then discussed at a prehearing conference with the ALJ, which can also serve as an opportunity for settlement. The hearing date is confirmed at that time (typically the hearing date is extended out from the first date listed in the order).
The hearing is held either in person or through video teleconferencing, usually in a venue in a major city in the same area as the registrant. Following the hearing, both parties are offered the opportunity to file post-hearing briefs, which should also list the proposed factual findings and legal conclusions. After receiving those briefs, the ALJ will issue a recommended decision. Both parties receive the decision and are offered the opportunity to file exceptions to the ALJ’s recommendation if they believe it contains errors. After waiting at least 25 days from when the recommended decision is issued, the ALJ certifies the case record and sends it to the Office of the Administrative for final review. That record, along with the recommended decision, are reviewed and either adopted or non-adopted by the Administrator.
We represent healthcare professionals in proceedings before the Drug Enforcement Administration. If you are facing discipline, we can help with experienced administrative law representation.