How Long Does it Take to Get a DEA License Number? - Federal Lawyer
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How Long Does it Take to Get a DEA License Number?

dea license

All healthcare providers and other entities in the U.S. that manufacture, compound, administer, or dispense prescription medications must register with the Drug Enforcement Administration (DEA). Under federal law, anyone who will dispense controlled substances needs a DEA registration. DEA licensing is mandatory, and working with prescription medications in any capacity without a DEA license can expose providers and other entities (and individuals) to substantial penalties. As the DEA’s licensing and registration regulations plainly state:

“No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.”

Given that this is the case, and given that the federal government has a tendency to move slowly, you might be wondering: How long does it take to get a DEA license number?

The short answer is, “It depends.”

Generally, obtaining a valid DEA number should take somewhere in the range of four to six weeks. This is the Administration’s stated timeframe for processing new license number applications filed using DEA Form 224. However, the process often takes significantly longer; and, to avoid unnecessary delays, healthcare providers and others should work with experienced DEA compliance counsel to ensure that they meet all applicable licensing requirements.

The Process for Obtaining a DEA License Number

Obtaining a DEA license number, or DEA registration number, is supposed to be a relatively straightforward process for eligible applicants. While the DEA has a strong interest in ensuring that controlled substance medications do not end up in the wrong hands, it also has a strong interest in ensuring that healthcare providers have access to the prescription medications their patients need. Additionally, due to the volume of new DEA registration or license number applications it receives, the DEA works to process valid applications as efficiently as possible.

For healthcare providers, completing DEA Form 224 typically takes about 30 minutes, provided that they have all necessary information readily available. But, as it is easy to make mistakes (more on this below), it is best to hire an experienced attorney to assist with preparing your license application. Many applicants seek legal representation; and, if you click through the DEA’s online application, you will see that one of the first steps is uploading a signed Power of Attorney.

It’s also worth noting that knowingly submitting false information on a DEA license number application is a serious federal crime. Under 21 U.S.C. Section 843(d), knowingly filing a DEA license number application with false information carries up to four years of federal imprisonment and a $250,000 fine. Even if you inadvertently submit false information, you may be forced to convince the DEA that your mistake was unintentional. This is another important reason to consider working with an attorney who can help guide you through the application process.

In many cases, filing DEA Form 224 is the only step in the DEA number application process. If you submit all required information and the Drug Enforcement Agency doesn’t flag any issues with your application, you may simply receive your license number in four to six weeks. But, various issues can—and do—arise, and these issues can lead to delays in registration as you work to address the DEA’s concerns.

Issues that Can Delay the DEA Registration Process

While it should typically take about four to six weeks to get a DEA license number and DEA certificate from the date that you submit DEA form 224, there are several issues that can delay the issuance of your license number—or potentially even lead to denial of your application. Some examples of these issues include:

  • Denial, suspension, or revocation of a state medical, pharmacy, or dental license 
  • Exclusion from Medicare or Medicaid due to billing compliance violations 
  • Convictions for certain felony offenses 
  • Submitting a DEA license number application with false information 
  • Omitting required information from a DEA license number application (DEA Form 224)

The DEA can also deny a license number application if it determines that granting a license number would be “inconsistent with the public interest.” The DEA makes this determination pursuant to 21 U.S.C. Section 823, which provides that granting a license number may be “inconsistent with the public interest” if the applicant has:

  • Failed to maintain effective diversion controls; 
  • Failed to comply with state or local law; 
  • A prior conviction related to the manufacture, distribution, or dispensing of controlled substances (regardless of whether the conviction was for a felony offense); 
  • Insufficient prior experience with the distribution of controlled substances; or, 
  • Any other relevant history that warrants denial. 

If the DEA identifies an issue with your registration application, instead of issuing a license number it will issue a “show cause” order. This means that the applicant’s request for a license number will be denied unless the applicant can affirmatively demonstrate (or “show cause”) why denial is unwarranted. The issuance of a “show cause” order can substantially increase how long it takes to obtain a DEA license number—and, at this stage, it is vital to work with experienced counsel who can communicate effectively with the DEA on your behalf.

The Timeline and Process if Your DEA License Number Application is Denied (if You Receive a “Show Cause” Order)

If the DEA issues a “show cause” order in response to your license number application, it will be up to you (and your counsel) to convince the DEA to reverse its provisional denial. The “show cause” order should state the basis for the provisional denial, and it should outline your options for responding. These options are:

  • Submit a corrective action plan; and/or 
  • Attend a hearing before the Attorney General at the time and place stated in the order (the hearing will be scheduled within 30 days). 

Corrective action plans can take various forms; and, if you need to submit a corrective action plan, you will need to work with your counsel to determine what is necessary and appropriate. While 21 U.S.C. Section 824(c)(3) provides that, upon submission of a corrective action plan, “the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan,” DEA license number applicants should seek to submit corrective action plans that do not require modification, amendment, or clarification. Not only will this help to maximize the chances of securing a DEA license number, but it will also help to minimize the overall timeline of the process. At this stage, the timeline can become significantly protracted, and it is up to applicants (and their counsel) to seek to resolve the DEA’s concerns as efficiently as possible.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd
Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara
Linda Julin McNamara

Federal Appeals Attorney

Aaron L. Wiley
Aaron L. Wiley

Former DOJ attorney

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (DOJ)

Chris Quick
Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow
Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

5 Tips for Minimizing the Processing Time of a DEA License Number Application

While there are several issues that can delay (or prevent) the issuance of a DEA license number, there are also several steps that healthcare providers and other applicants can take to help minimize the processing time of their applications. Some examples of these steps include:

1. Identify (and Address) Any Issues that May Render Your Application “Inconsistent with the Public Interest”

If there is a chance that the DEA may deem your application “inconsistent with the public interest,” addressing the DEA’s potential concerns proactively can help you avoid unnecessary delays. Depending on the circumstances, this may involve taking corrective action before you file your application, or it may involve gathering the documentation you will need to respond to a “show cause” order if necessary.

2. Identify (and Address) Any Other Potential Grounds for Denial

Along with proactively addressing any issues that may render your application “inconsistent with the public interest,” you will also want to proactively address any other potential grounds for denial. Here, too, putting in additional effort up front can help minimize the time it takes to obtain your DEA license number.

3. Ensure that You Include All Required Information in Your DEA License Number Application

When you submit your DEA license number application, you need to make sure that it includes all required information. Omitting required information is among the most common reasons for unnecessary delays and provisional denials.

4. Keep All Documentation that Supports Your DEA License Number Application Readily Available

To ensure that you are prepared to respond to a “show cause” order if necessary, you should keep all documentation that supports your DEA license number application readily available. Hopefully this won’t be necessary; but, if it is, being prepared will help to facilitate an efficient and favorable resolution.

5. Work with Experienced DEA Compliance Counsel

Engaging experienced DEA compliance counsel to help you file your DEA license number application will help you avoid inadvertent mistakes that result in unnecessary delays. Experienced DEA compliance counsel will also be able to assist with proactively addressing any concerns with your application, and will be able to work with the DEA and Attorney General efficiently on your behalf if necessary.

Get Help from the DEA Compliance Lawyers at Consultants at Oberheiden P.C.

Are you preparing to submit a DEA license number application? If so, we invite you to contact us for a free, no-obligation consultation. Call 888-680-1745 or get in touch online to schedule an appointment with a DEA compliance lawyer at Oberheiden P.C. today.

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