Physicians, pharmacists, dentists, nurse practitioners, veterinarians, and other prescribers and dispensers who plan to prescribe or dispense controlled substances must have a Certificate of Registration from the Drug Enforcement Agency. While obtaining a DEA registration may be straightforward for some, others have difficulty due to various issues including prior licensing or disciplinary issues, the nature or area of their practice, lack of experience, etc. Our professional licensing attorneys are dedicated to helping prescribers obtain and protect their DEA registration. We assist prescribers with applications for DEA registration, denials, appeals, and DEA show cause hearings.
The following questions address issues that prescribers and dispensers should consider when applying for a DEA Registration.
The DEA’s website states that new applications (DEA Form 224) are processed within 4 to 6 weeks, while renewal applications (DEA Form 224a) are processed within approximately 4 weeks.
However, it is our experience that application processing can take significantly longer than the stated times. Applicants often spend months hearing little or nothing from the DEA while incurring significant costs and losing income due to the lack of a DEA Registration.
If you find yourself in this situation, you should consider hiring an attorney. Chapman Law Group has experience working with administrative agencies. An attorney’s involvement often causes the DEA to take prompt action on your application.
The statutory (legal) reasons for denying an application include the following:1
If the DEA believes that they have valid reasons to deny your Registration, they will issue you a show cause order. The law states that before denying any application, the DEA Administrator must issue an order to show cause and must hold a hearing if the applicant requests one22.
A hearing to show cause is a complicated legal proceeding that determines your substantive rights. You should immediately hire an attorney experienced in administrative proceedings, like the Chapman Law Group, to argue your case at your hearing.
The DEA considers the following factors when determining whether your Registration would be considered “inconsistent with the public interest3.”
An order to show cause gives you the opportunity to appear before the DEA Administrator not less than 30 days after your receipt of the order4. The order to show cause will contain a statement of the legal basis for the hearing, the reason(s) for the denial, and a summary of the matters of fact and law asserted. Upon receipt of an order to show cause, you must file a request for a hearing. Failure to request a hearing will result in waiver of your right to a hearing.
You have 30 days from the time you are served with a show cause order to respond. Within those 30 days, either you or your attorney must request a hearing or submit a written statement in lieu of a hearing.5.
If you fail to respond within 30 days, an administrative law judge (ALJ) could find that you waived your rights to a hearing or to submit a written statement. Further, the ALJ could accept the DEA’s request for final agency action to deny your application for Registration.
As soon as you receive a show cause order, it is crucial that you hire an experienced attorney, like Chapman Law Group, who is knowledgeable in preparing you for and defending your rights at a show cause hearing.
The purpose of a show cause hearing is for an ALJ to review factual evidence regarding the issues involved in your registration denial6. Parties to the hearing present their case or defense by oral and documentary evidence, submit rebuttal evidence, and cross-examine adverse witnesses. Arguments are offered into evidence and presented in opening and closing statements of counsel. The ALJ also reviews memoranda of proposed findings of fact and conclusions of law. The burden of proof is on the DEA to show, by a preponderance of the evidence, that a violation occurred and that your application for Registration should be denied.
A hearing to show cause is a complicated legal proceeding where your substantive rights are determined. You should retain an attorney experienced in administrative proceedings, like the Chapman Law Group, to argue your case at the formal hearing.
As soon as practicable at the conclusion of your show cause hearing, the ALJ will certify the record and issue his/her final order granting or denying your DEA Registration7.If you are dissatisfied with the final order, you may appeal the final ruling to a federal court with appellate jurisdiction.
A professional licensing attorney can assist you in all aspects of your application for DEA Registration. Chapman Law Group’s professional licensing attorneys are available to answer any of your questions and to provide legal assistance when necessary.
Many regions of the United States are problem areas for pharmaceutical drug abuse including large sections of Florida, the Southeastern region of the United States, and the Upper Peninsula of Michigan. The media pays a great deal of attention to DEA enforcement actions including investigations of “pill mills” and practitioners who have over-dispensed or over-prescribed controlled substances in these problem regions. Consequently, practitioners in these problem areas often fear that they will have trouble obtaining a DEA Registration for themselves or their facilities.
However, recently a federal court decision held that “a rampant pharmaceutical drug abuse problem” in the region was not a valid reason for denial of an applicant’s Registration 3. The federal court said that “nothing in the law allows the DEA to deny an application for registration based on its assessment of the nature and amount of diversion of controlled substances in a geographical area”.
If the DEA tells you that they will not approve your Registration due to the extent of prescription drug abuse in your geographic area, then you should hire an experienced attorney, like the Chapman Law Group, to assert your rights.
Our attorneys assist prescribers with various DEA registration matters, including: application for DEA registrations, DEA registration denials and appeals, DEA show cause hearings, DEA registration revocation, DEA investigations and inspections, and DEA enforcement actions. If you are having difficulty obtaining a DEA registration or were denied, our professional licensing attorneys can work with the DEA on your behalf to help obtain a DEA registration. We recognize that the ability to prescribe controlled substances is an essential element to your practice and your career, and we want to help you obtain and protect your DEA registration.
1. 21 USC § 824
2. 21 CFR § 1301.35
3. 21 USC § 823
4. 21 CFR § 1301.37
5. 21 CFR § 1301.43(a) & (c)
6. 21 CFR § 1301.42
7. 21 CFR § 1301.46
8. Physicians Pharmacy, L.L.C.: Decision and Order, Federal Register Volume 77, Number 152 (2012)