If you are a health care professional who plans to prescribe or dispense controlled substances, you must have a certificate of registration from the DEA. This applies to physicians, pharmacists, dentists, nurse practitioners and veterinarians.
While obtaining a DEA registration may be straightforward for some, others have difficulty. Obstacles include prior licensing or disciplinary issues, the nature or area of practice, and lack of experience.
As professional licensing attorneys, we at Chapman Law Group are dedicated to helping prescribers obtain and protect their DEA registration. Here are answers to frequently asked questions about the DEA registration application process, and what happens when a prescriber or dispenser is denied.
The DEA’s website states that new applications (DEA Form 224) are processed within four to six weeks, while renewal applications (DEA Form 224a) are processed within approximately four weeks.
However, in our experience, the application processing can take significantly longer than the stated times. Applicants often spend months hearing little or nothing from the DEA, all the while incurring significant costs and losing income due to lack of a DEA registration.
If you find yourself in this situation, you should consider hiring an attorney, because a lawyer’s involvement often causes the DEA to take prompt action on your application.
The statutory (legal) reasons for denying an application include:
If the DEA believes that it has 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 one.
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 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 interest”:
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 order. 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.
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 health care lawyer 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 denial.
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.
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 registration. If you are dissatisfied with the final order, you may appeal the final ruling to a federal court with appellate jurisdiction.
Many regions of the United States are problem areas for pharmaceutical drug abuse. This includes large sections of Florida, the Southeastern region of the U.S., 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 overdispensed or overprescribed controlled substances in these problem regions. Consequently, practitioners in these areas often fear they will have trouble obtaining a DEA registration for themselves or their facilities.
However, a 2012 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. The federal court determined 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.”
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.
If you are having difficulty obtaining a DEA registration or were denied, our DEA regulatory attorneys can work with the DEA on your behalf to help obtain a DEA registration.
Our four national DEA matters and healthcare defense law offices are in Miami and Sarasota, Florida; Detroit, Michigan; and Los Angeles/Southern California.
Contact us today for more information about our DEA registration services, as well as other DEA matters we handle for healthcare providers.
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