Non-Compliance with the DEA’s Registration Requirements Can Have Severe Consequences for Physicians. So, Can You Continue to Prescribe While Your Registration is Pending Renewal?
As a physician, your ability to prescribe medications is fundamental to your ability to practice. It is also subject to the authority of the U.S. Drug Enforcement Administration (DEA). The DEA requires all physicians to register before prescribing, and physicians must keep their registrations active at all times.
So, what happens when your DEA registration renewal is pending?
The DEA registration renewal process takes time. It normally takes about four to six weeks; and, if the DEA initiates an inspection or investigation, it can potentially take a year or longer to work through the process. As a result, it is not unusual for physicians to find themselves in the position of being past their expiration date with their DEA renewal applications still pending. If you find yourself in this position, here is an overview of what you need to know:
The 45-Day Rule for DEA Registration Renewals
When filing for DEA registration renewal, the implications of passing your current expiration date depend on two key factors. The first is when you file your renewal application.
The DEA has established a 45-day rule for determining the impact of registration expiration on a physician’s ability to prescribe controlled substance medications. Under 21 C.F.R. Section 1301.36(i):
“In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the [DEA] has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the [DEA] so issues [its] order.”
In other words, as long as a physician files for renewal at least 45 days prior to the expiration date of the physician’s current registration, the physician’s registration will remain active. The DEA grants an “automatic extension” that allows for continued prescribing during the pendency of the physician’s renewal application (provided that the DEA has not expressly revoked the physician’s privilege to prescribe).
However, if a physician files for renewal fewer than 45 days before the physician’s current registration expires, then the physician does not receive an automatic extension. Instead, whether the physician may continue prescribing is subject to the DEA’s discretion. As 21 C.F.R. Section 1301.36(i) goes on to state:
“The [DEA] may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the registrant, if the [DEA] finds that such extension is not inconsistent with the public health and safety.”
While the DEA may grant an extension in this scenario without a request, as a physician, you do not want to be waiting for a letter from the DEA to find out if you will be able to continue prescribing. As a result, if you are not able to file your DEA registration renewal application more than 45 days prior to the expiration of your current three-year registration, you will want to work with your lawyer to submit a timely and appropriate request to the DEA.
DEA Orders Prohibiting the Prescription of Controlled Substance Medications
The second key factor is whether the DEA has issued an order prohibiting you from prescribing controlled substance medications (i.e. a DEA registration revocation or suspension). If the DEA has revoked or suspended your registration, then you may not continue to prescribe—even if you file your renewal application more than 45 days prior to your current expiration.
Facing a DEA Inspection or Investigation During the Registration Renewal Process
As noted above, the DEA registration renewal process typically takes about four to six weeks. This means that if you file your DEA 224a form 45 days before your current registration expiration date, then your automatic extension should last no more than a couple of weeks.
If it takes more than six weeks to receive approval for your DEA registration renewal application, this could mean that DEA agents have decided to conduct an inspection or investigation. In this scenario, you will still be able to continue prescribing under the automatic extension (if you filed for renewal at least 45 days prior to expiration)—unless the DEA says otherwise.
In any case, if you are facing a DEA inspection or investigation, you need to take your situation very seriously. These inquiries have the potential to lead to several adverse outcomes. For example, one possibility is that the DEA could issue a “show cause” order requiring you to provide justification for why your renewal application should not be denied.
If a DEA inspection or investigation uncovers evidence of violations of the Controlled Substances Act (CSA), Drug Supply Chain Security Act (DSCSA), the DEA’s Electronic Prescriptions for Controlled Substances (EPCS) regulations, or any other pertinent sources of statutory or regulatory authority, the DEA may ask you to surrender your registration. It may also suspend or revoke your registration outright. These types of violations can potentially lead to civil or criminal charges as well—and DEA violations can also trigger disciplinary action by a physician’s state medical licensing board.
Protecting Your DEA Registration and Ability to Prescribe Controlled Substance Medications
With these risks in mind, as a physician, it is important to take proactive steps to protect your ability to prescribe during the DEA renewal process. Some examples of these steps include:
- File Your DEA Renewal Application At Least 45 Days Before Your Current Registration Expires – As long as you file your DEA 224a form 45 days (or more) before your current registration expires, you will receive an automatic registration extension in the event that it takes more than 45 days for the DEA to approve your renewal.
- Consult with a Lawyer if You File for Renewal Fewer Than 45 Days Before Your Pending DEA Expiration Date – If you file for renewal fewer than 45 days before your pending DEA expiration date, you will not receive the automatic extension. This means that you could lose your ability to prescribe when your current registration expires. In this scenario, you will want to hire a lawyer to request an extension from the DEA.
- Consult with a Lawyer if the DEA Renewal Process Takes More Than Six Weeks – Since the DEA registration renewal process usually takes about four to six weeks, you should consult with a lawyer if the process extends beyond this time period. Even if you received an automatic extension that allows you to continue prescribing, you will want to address any issues with your renewal—and you will also want to find out if the DEA is conducting an inspection or investigation.
FAQs: Protecting Your Ability to Prescribe During the DEA Renewal Process
Do I Need to Be Concerned About Losing My Ability to Prescribe During the DEA Renewal Process?
While most physicians won’t lose their ability to prescribe during the DEA renewal process, this is a possibility with every renewal. If you wait too long to file your renewal application, or if the DEA rejects your renewal application for any reason, you could lose your ability to prescribe—either temporarily or permanently.
How Can I Avoid Losing My Ability to Prescribe During the DEA Renewal Process?
One of the simplest ways to avoid losing your ability to prescribe is by filing your renewal application at least 45 days before your current registration expiration date. This provides an automatic extension in the event that the renewal process takes more than 45 days. But, you must be sure to properly complete the renewal application as well, and you must be prepared to promptly address any inquiries from the DEA.
Why is the DEA Conducting an Inspection or Investigation During My Renewal?
The DEA conducts inspections and investigations to assess prescribers’ compliance with the Controlled Substances Act and other pertinent sources of authority. In some cases, it chooses prescribers at random. In others, it chooses to conduct an inspection or investigation based on information contained in a prescriber’s renewal application or received from third parties.
Do I Need a Lawyer to File for DEA Renewal?
While many physicians handle their DEA renewals on their own, hiring a lawyer helps to mitigate the risk of unnecessary delays and denials. Additionally, in the event that the DEA conducts an inspection or investigation, having a lawyer who is familiar with your renewal application and registration history can help facilitate a swift and favorable resolution.
Do I Need a Lawyer for a DEA Inspection or Investigation?
If you face a DEA inspection or investigation during the registration renewal process, you should contact a lawyer right away. These inquiries present several significant risks, and it will be important for you to have experienced legal representation.
Speak with a DEA Compliance and Defense Lawyer at Oberheiden P.C.
Do you have questions or concerns about the DEA registration renewal process? If so, we invite you to get in touch. Please call 888-680-1745 or contact us online to arrange a complimentary consultation.