It’s no secret that the alphabet soup of regulatory agencies can intimidate veterinary professionals. In the ’80s and ’90s, OSHA (Occupational Safety and Health Administration) was a four-letter word that terrified the industry. When practice owners started to feel safe again, another regulatory shark entered the waters. Today, the DEA (Drug Enforcement Administration) and the potential for a surprise visit are what cause practice owners to have sleepless nights and panic-filled days. Why? The fear of the unknown.
When DEA regulations were written in the 1970s, the primary focus was on controlled substances in human health care, leaving certain aspects in veterinary medicine vague, unclear or unaddressed. Interpreting DEA regulations in veterinary medicine is an ongoing area of debate and confusion.
The questions I often hear are:
- What is the difference between a DEA audit and an inspection?
- How does the DEA select registrants to visit?
- Does the DEA share information with state veterinary medical boards?
- What are the differences between a letter of admonition, a memorandum of agreement and DEA administrative actions?
- How are penalties assessed, and can they be negotiated?
- Can you challenge violations and penalties?
- When do you need an attorney?
Here’s what I know as a DEA and regulatory compliance expert.
DEA Inspections and Audits
Those terms are often used interchangeably but are not synonymous.
DEA inspections are routine visits that primarily involve reviewing records and security measures to ensure adherance to regulatory requirements. The agency typically conducts inspections during the registration approval process. Follow-up inspections are common at registered premises.
DEA audits are in-depth reviews focused on accounting for controlled substances. The audits can be random or triggered by DEA-acquired information. If a registrant is noncompliant, the consequences can range from formal warnings and corrective action to fines, suspensions or a registration’s revocation. In some circumstances, criminal prosecution is possible.
The DEA uses data to select and prioritize which veterinary practices to visit. High-volume prescribers in certain states are more likely to be inspected or audited. Currently scrutinized states include Arkansas, Alabama, West Virginia, Mississippi and Louisiana.
Anonymous calls by disgruntled current or former employees might trigger unannounced visits. The DEA also works with state boards. Therefore, if you violate state drug laws and a state board cites you, there’s a good chance the DEA is aware.
When Do You Need an Attorney?
Always seek legal counsel at the start of a DEA inspection or audit or upon receipt of a DEA warrant or administrative action. I recommend hiring an attorney specializing in DEA and Department of Justice matters.
Letter of Admonition
A letter of admonition is at the lower end of the DEA audits and inspections scale. Its receipt means the DEA found cause to believe you are not fully compliant. The letters are frequently associated with minor violations that do not warrant civil or criminal liability. They warn that issues were identified and must be corrected. Don’t take the notice lightly. Failing to address issues outlined in the letter can escalate the matter. Ignorance is not bliss.
Memorandum of Agreement
If the DEA alleges noncompliance, a corrective action plan might include a memorandum of agreement setting forth specific expectations regarding the ongoing management and handling of controlled substances. When negotiating the memorandum’s terms, documentation supporting your defense is critical to ensure the expectations and penalties aren’t excessive. Again, I recommend consulting an attorney with expertise in DEA and Justice Department matters.
DEA Search Warrants
In certain situations, the DEA might arrive with a warrant, though the agency generally doesn’t need one to inspect a controlled substance inventory and records at a DEA-registered premises. On the other hand, searching private property requires a warrant from a magistrate or judge.
Two types of DEA search warrants exist.
1. ADMINISTRATIVE INSPECTION WARRANT
If a registrant refuses to sign DEA Form 82, which acknowledges informed consent to inspect a registered premises, the agency can obtain an administrative inspection warrant. The document allows agents to return and identify violations of administrative regulations. The DEA also may access patient records.
The DEA is not required to obtain an administrative inspection warrant when:
- The DEA issued an administrative subpoena for inspection of the registrant’s books and records.
- The target applied for an initial DEA registration.
- An imminent threat to public health or safety is present, and the DEA lacks sufficient opportunity to obtain a warrant.
2. CRIMINAL SEARCH WARRANT
If the DEA shows up with a criminal search warrant, the situation is extra serious. Criminal search warrants obtained from a federal judge require a higher level of probable cause and are typically part of a larger DEA investigation. Federal criminal search warrants are subject to other requirements and limitations, such as Rule 41 of the Federal Rules of Criminal Procedure.
To demonstrate probable cause, the DEA usually submits an affidavit with underlying facts, which is why the agency often gathers preliminary evidence before planning a formal search or seizure.
Does the DEA show up with search warrants at veterinary practices? Speaking from firsthand experience, I know the answer is yes.
True story: Upon returning home on a red-eye flight from back-to-back client stops, my phone buzzed once, twice, three times.
- Text 1: “HELP!!!!”
- Text 2: “HUGE DEA ISSUE!!!”
- Text 3: “PLEASE CALL!!!”
That morning, the DEA arrived unannounced with search warrants and a law enforcement task force. Carried out in boxes were all controlled substances in the hospital’s inventory, records and other items. The registrant’s personal belongings were searched and seized. Team members and pet owners arriving for work or appointments were directed to the parking lot.
I repacked my suitcase and was on the next flight out. I spent a week helping the client and legal counsel navigate the issues.
If the DEA shows up with a warrant, contact your attorney immediately.
Order to Show Cause
An order to show cause is the start of formal proceedings to revoke, suspend or deny a DEA registration. The agency may suspend or revoke a registration upon finding that someone has:
- Materially falsified an application.
- Been convicted of a felony under the Controlled Substances Act or any federal or state law relating to controlled substances or a listed chemical. (Remember that marijuana remains a Schedule I controlled substance.)
- Had a state license or registration suspended, revoked or denied and is no longer authorized by state law to manufacture, distribute or dispense controlled substances.
Immediate Suspension Order
An immediate suspension order may be served with an order to show cause. It allows the DEA to circumvent due process and restrict a registrant’s registration pending a hearing if imminent danger to public health and safety is alleged. If you receive such an order, you cannot dispense controlled substances while the case is pending.
Fines Will Cost You
Monetary penalties may be assessed. Notification will arrive in a Justice Department letter that encourages the registrant to obtain legal counsel.
DEA registrants should not contact the agency or Justice Department on their own because missteps could result in additional consequences. Make sure an attorney experienced in defending cases of civil monetary penalties handles negotiations on your behalf.
The DEA may assess fines of up to $15,691 per violation. During my visits to over 800 hospitals for routine assessments, I found an average of 11 violations that would warrant a fine.
Can you challenge DEA findings and get fines reduced or waived? Depending on the circumstances and with a good attorney, yes. The deciding factors can be:
- The defendant’s level of culpability.
- The public harm caused by the violations.
- The defendant’s profiting from the violations.
- The defendant’s ability to pay.
Understand that mishandling controlled substances can be costly. Failing to prioritize DEA compliance will only increase the financial penalties, and the consequences tend to compound.
If you find yourself in the DEA’s crosshairs, don’t try to navigate your way out on your own. You need the right attorney and other experienced professionals.
REAL-LIFE CASES
Here are two recent examples of DEA inspections and audits in veterinary medicine.
- A Maine veterinarian agreed to pay $145,360 to resolve claims that he violated the Controlled Substances Act due to improper drug storage and recordkeeping violations.
- A New Hampshire veterinary hospital agreed to pay $53,500 to resolve allegations of failing to keep accurate records of controlled substances, including opioids.