Getting a registration and maintaining it can take just a few simple steps, but seems to be at the core of many practitioner’s questions and concerns.
Titan’s clients are reminded regularly that having a DEA registration is a privilege, not a right: there is no law that says as a veterinary professional you have the right to a DEA registration. When you register with the DEA to handle controlled substances, you are granted legal authority to prescribe, administer and dispense these potent medications. But you are also accepting full legal responsibility for all aspects of how you and your practice work with those powerful drugs. If you fail badly enough to meet your legal obligations, the coin can flip and your registration could be revoked.
Heads – Getting and Keeping Your DEA Registration
Under the federal Controlled Substances Act (CSA), veterinarians (along with physicians, dentists, scientific investigators, pharmacies, hospitals and certain mid-level practitioners) who wish to handle controlled substances must be registered with the DEA or have some type of official, legal exemption from registering. Keep in mind, as a DEA-registered practitioner you may only engage in activities with controlled substances that are authorized under your state’s laws, where your practice is located. If federal regulations differ from your state’s regulations, you must follow whichever is more stringent.
So, how do you apply for a DEA registration? Just submit DEA Form 224 online or via hard copy (see below for online resources). Be sure you have all required state licenses and certifications (some states have a separate controlled substance license) before you apply for the DEA registration.
How many DEA registrations do you need? This is one of the most common points of confusion, especially for veterinarians who work at multiple clinics. It comes down to where you fall under the following conditions:
- If you have only one clinic/office where you practice, you only need one registration.
- If you have multiple clinics/offices in one state and you only prescribe controlled substances at those multiple locations, you only need one registration.
- If you have multiple clinics/offices in one state and you have supplies of controlled substances to administer or dispense at those multiple locations, you need a separate DEA registration for each location.
- If you practice in multiple states, you need a DEA registration for each state where you practice.
When you apply for your DEA registration, be sure to keep an important concept in mind: the “registered location.” The business address you provide on your DEA application is considered your “registered location” — the primary place of business where your DEA certificate, all required records and controlled substances must be kept and readily retrievable for DEA inspections. The big mistake veterinarians make? Listing their home address as the registered location. While the law does not prohibit using your home address, when your home is listed as the registered location you automatically give DEA investigators permission to come there, enter the premises and request required records. If the required records are not in the registered location (your home), you now have a legal violation.
The DEA registration does, however, allow for a separate “mail to” address where all official correspondence (including renewal reminders) will be sent. Using a home address as your “mail to” is allowed and does not have the legal entanglements of a registered location.
Don’t forget to renew your registration before the deadline. Your DEA registration renews every three years using Form 224a on the DEA registration page (see below). But the DEA has changed its approach to renewals in a crucial way! Unlike the old days where there were multiple reminders and grace periods to complete the renewal, today if you miss the renewal deadline, your DEA number is removed and cannot be retrieved. You will have to get an entirely new DEA registration. Don’t delay or your number goes away!
If you move your practice to a new physical location, you must request a modification of your registration either online or in writing to your local DEA field office. If your address change involves moving to another state, you must be sure to have all required state licenses and state-controlled substances registrations before requesting the DEA registration modification.
Tails – Losing Your DEA Registration
There are two basic ways in which your DEA registration can be removed:
- Voluntary actions – When you retire, close your practice or for any other reason choose not to handle controlled substances professionally, you can simply contact your local DEA office to terminate your registration. You send a letter notifying the DEA of your desire to terminate your registration, along with your DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222). Done!
- Nonvoluntary actions – DEA takes violations of the CSA by professionals such as veterinarians very seriously. When you seek the privilege of having a DEA registration, you are committing to follow all relevant state and federal laws. If you have a record of noncompliance and violations, DEA has the discretion and authority to take action against you and your registration in several ways.
- Letter of admonition – A written warning documenting your violations. You will have 30 days to respond with a plan of correction. Failure to respond or to implement the promised corrections can lead to civil fines of up to $14,500 per violation as well as additional sanctions.
- Memorandum of agreement (or memorandum of understanding) – A contract between you and the DEA, requiring specific actions you must take within a specific time frame to be considered in compliance. Failure to abide by the terms of the agreement may result in more severe, restrictive sanctions.
- Request for voluntary surrender – If your violations are serious enough, the DEA may ask you to voluntarily surrender and terminate your registration. Be warned, a voluntary surrender does not necessarily stop other disciplinary or legal actions against you by the DEA or other entities.
- Order to show cause/denial, suspension or revocation of registration – Considered the most serious of actions against a registrant, you would be served an order to show cause (OTSC) to revoke, suspend, or deny your registration if you:
- Materially falsified an application
- Were convicted of a felony relating to a controlled substance or a List I chemical
- Had your state license or registration suspended, revoked or denied
- Committed an act which would render your DEA registration inconsistent with the public interest
- Were excluded from participation in a Medicaid or Medicare program
Online resources: The DEA has online information, forms, and tools to make managing your DEA registration easier.
- www.deadiversion.usdoj.gov –The DEA’s Diversion Control Division, the unit responsible for managing all aspects of your DEA registration.
- www.deadiversion.usdoj.gov/drugreg –The DEA registration resource center contains all forms, rules, regulations and FAQ’s regarding registrations.
- www.deadiversion.usdoj.gov/pubs/manuals – The DEA’s manuals, containing controlled substances rules and regulations in plain English. All of the manuals are PDFs for easy download and distribution to your staff.
- Telephone resources – Contact your local DEA office if you are having problems with your registration application or renewal. Larger offices may have registration pro- gram specialists who can answer questions and process your applications. You can also call and ask to speak with one of the on-duty diversion investigators — they can answer questions and help resolve registration problems. There are also employees available at the national Registration Call Center at 1 (800) 882-9539 (weekdays 8:30 a.m. to 5:50 p.m., Eastern Time). During non-business hours, some in- formation is available through prerecorded menus.
The Magic Coin – No Heads or Tails
There are actually two basic situations where you do not need to have your own personal DEA registration at all:
- You are not handling controlled substances. Maybe retirement is on the horizon (or already here), the therapies you choose for your patients only require non-controlled substances or you have some other reasons to avoid controlled substances altogether. Whatever your situation, if your practice does not need controlled substances, you do not need a DEA registration. (Sorry, you will still need a state veterinary license!)
- You work under another veterinarian who purchases all of the controlled substances for the practice. If Dr. Smith uses her DEA registration number to purchase the controlled substances for everyone to use, Dr. Jones can administer them to his own patients (with the permission of Dr. Smith, of course, and proper record keeping). Be aware, if Dr. Jones wants to prescribe controlled substances, he will still need his own DEA registration.
The rules for getting and keeping your authority to use controlled substances for treating your patients are very clear — as are the penalties for abusing that privilege. Of course, every person’s situation is unique and different, so if you need help, be sure to ask — whether from your attorney, the DEA or a reputable compliance consultancy. Because it can go either way, depending on whether you make smart, informed choices or take poor shortcuts.
So, which way will your coin toss land?
I must make a disclaimer: I have been using drugs, buying drugs, investigating drugs and studying drugs for the past 32 years. I am a self-professed expert in all things drugs. Twenty-six years with the DEA, combined with personal experience taking pain pills for a bad back, gives me a perspective that is quite unique. Nothing in books or on TV can prepare one to deal with the devastating issues that surround drug addiction. Titan’s mission is to educate not only doctors and pharmacists, but the other side as well, in hopes that together we can end the story of opioid addiction once and for all.
A few insider tips for DEA registration success:
- Get your state licenses and certifications fully approved before applying for your DEA registration. Your DEA registration is tied to the existence of a legitimate state license. If you apply for a DEA registration without a state license you will be rejected, and your application fee forfeited.
- Liability 1 – Read the liability questions carefully and answer them honestly. The DEA asks about any legal issues involving your handling of controlled substances (arrests, disciplinary actions, license surrenders, etc.). False answers — or failing to answer them if you have sanctions in your history — could be grounds for immediate revocation of existing DEA registrations.
- Liability 2 – If you have criminal sanctions or disciplinary actions related to controlled substances in your background, consult with an attorney who is familiar with licensing issues before applying, to be sure your past cases are adequately resolved. You should be prepared for the DEA to conduct a liability investigation before deciding whether or not to approve your application.
- If someone completes your paperwork for you, read over it carefully before submitting it. They may fill out the forms, but you are held responsible for what is submitted.
- Don’t wait until the last minute to renew. Online systems break down, schedules get busy and many other glitches can delay a renewal. If you fail to renew in time, you will lose your existing DEA number and never get it back.
- Keep your registration information (e.g., addresses, telephone number, email) up to date via the DEA’s online registration website to avoid lost correspondence and hassles in contacting you for renewals or other official business.