The Drug Enforcement Administration (DEA) administers a portion of the Controlled Substances Act (CSA) that requires (i) all businesses that import, export, manufacture, or distribute controlled substances; (ii) all health care practitioners entitled to dispense, administer, or prescribe controlled pharmaceuticals; and (iii) all pharmacies entitled to fill prescriptions to register with the DEA. See 21 U.S.C. § 801 et seq. and 21 C.F.R. § 1300 et seq. If the DEA finds a registrant has violated the CSA, it has two tools in its arsenal to take administrative action, an order to show cause and an immediate suspension order.
Bases for Administrative Action
An order to show cause essentially asks the registrant to explain why the DEA should not revoke, suspend, or deny their registration to import, export, manufacture, dispense, prescribe, administer, fill, or otherwise distribute controlled substances. In contrast, in the event an alleged violation appears to pose an imminent threat to the public health, the DEA may issue an immediate suspension order prohibiting the registrant to deal in controlled substances immediately. 21 U.S.C. §§ 823 and 824. Both actions trigger the right to a hearing for the registrant.
The CSA authorizes the DEA to deny, suspend, or revoke a DEA registration in the following instances:
- the registrant has materially falsified any registration application filed
- the registrant has been convicted of a felony relating to a controlled substance or a chemical important to the manufacture of a controlled substance
- the registrant had its state license or registration suspended, revoked, or denied
- the registrant committed an act which would render the registration inconsistent with the public interest
- the registrant has been excluded from participation in a Medicaid or Medicare program
21 U.S.C. § 824(a).
Litigation Process Overview
To suspend or revoke a registration, the DEA first serves the order (i.e. to show cause or immediate suspension) on the registrant. The order will set forth the details regarding the right to a hearing. However, to obtain a hearing, the registrant must file a formal request within 30 days of being served with the order. 21 C.F.R. § 1301.43(a). Once a request for hearing is filed, a federal administrative law judge (ALJ) is assigned to resolve the case. If a registrant fails to file the request, the right to a hearing is deemed waived, and the case will be fast tracked to a federal ALJ for a final decision. 21 C.F.R. § 1315.56(e).
For registrants that request a hearing, the process starts with the ALJ issuing an order setting forth the initial deadlines for prehearing discovery and written briefs. First, the parties will be required to file a written prehearing statement (DEA first then the registrant) identifying the issues they intend to litigate in the hearing and the documents and witnesses they plan to introduce. Once the statements are filed, the ALJ conducts a prehearing conference to discuss the possibility of settlement and sets a hearing date. 21 C.F.R. § 1316.54. The hearing is held either in person or through video teleconferencing and subsequently, the parties are required to file post-hearing briefs containing proposed findings of fact and conclusions of law. 21 C.F.R. § 1316.64. Finally, the ALJ will issue a recommended decision that will be forwarded to the Office of the Administrator for final review and issuance of a decision either adopting, modifying, or rejecting the ALJ’s recommended decision. 21 C.F.R. §§ 1301.46 and 1316.67.
Appeal Rights
Registrants have the right to appeal the decision to a U.S. Court of Appeals. If the decision is not appealed, the administrative action is final.
If you have any questions regarding the DEA registration process, hearings, and/or appeals, please do not hesitate to contact attorney Matthew M. Fischer (matt@fischerlawpa.com). Matthew specializes in health law related issues and is a former Assistant General Counsel at the FBI and Senior Attorney Advisor at the U.S. Department of Health and Human Services.