DEA Inspection and Administrative Search

What is a Drug Enforcement Administration Administrative Inspection?

You may be the subject of a DEA inspection or an administrative search if there are allegations of a violation of the Controlled Substance Act. The Drug Enforcement Administration, through its Office of Drug Diversion Control, has steadily increased its administrative inspections of pharmacies and physician offices.

An inspection is a visit by a group of Drug Enforcement Administration agents. The Drug Enforcement Administration has the legal authority to conduct an unannounced inspection of a person holding a DEA registration to assure that the person being inspected is complying with laws related to the dispensing, prescribing, sale, destruction, record-keeping, etc. of controlled substances.

Why is the Drug Enforcement Administration Conducting an Administrative Inspection?

There may be several reasons that the Drug Enforcement Administration had decided to conduct an inspection. The Drug Enforcement Administration may have received information that the provider is not complying with certain laws governing controlled substances. Information may be received through data mining, review of ARCOS, review of the specific state databases, e.g., EForce in Florida, review of a provider’s order history, or through information from third parties – staff, competitors, patients, other providers, etc. Identifying the source or sources of the information leading to the inspection might permit the provider to determine precisely why the Drug Enforcement Administration is now requesting an administrative inspection.

Who Conducts a Drug Enforcement Administration Administrative Inspection?

Agents from the Drug Enforcement Administration. Determining who the agents are is critical. Agents or investigators might be from the Office of Diversion Control or agents might be Special Agents primarily responsible for investigating criminal conduct. More often than not, at least 2 agents or investigators will show up unannounced on scene to request consent for an administrative inspection.

What Can a Provider or Pharmacy Expect During a Drug Enforcement Administration Administrative Inspection?

A provider or office manager on site confronted with agents seeking to conduct an administrative inspection should expect to receive a DEA Form 832 Notice of Consent to Inspection. The Notice of Consent will tell the provider that he or she may consent to or refuse the inspection. The Notice of Consent also states that the provider may grant consent without an administrative warrant but that any incriminating evidence found during the inspection may be used in any civil, administrative, or criminal proceeding.

An agent on site may tell the provider that even if they refuse the inspection they will be able to obtain an administrative warrant as a matter of course. An agent may also request to interview certain employees or staff on site or request that the provider submit to an interview.

In some cases, an agent on site might also request that the provider sign a DEA Form 104 Voluntary Surrender of Controlled Substance Registration surrendering the DEA registration. Upon signing the DEA Form 104 and handing it to the DEA agent or investigator, the DEA registration is immediately revoked.

What Happens if a Provider or Pharmacy Agrees to a Drug Enforcement Administration Administrative Inspection?

If a provider agrees to an inspection, then agents will inspect records, patient files, etc. to determine whether the provider is compliant. Agents may also request to interview staff on site. If a provider completes Notice of Consent to Inspection, then whatever documents or records are discovered during the inspection may also be used in any subsequent administrative, civil, or criminal proceeding.

What Happens if a Provider or Pharmacy Refuses a Drug Enforcement Administration Administrative Inspection?

If a provider refuses inspection, agents should honor that refusal and the refusal should not be viewed as obstructive conduct. If a provider refuses the inspection, an agent on site might suggest that a refusal is only going to complicate the process because an agent will be able to obtain an administrative warrant as a matter of course and the requirements for obtaining an administrative warrant are not overly burdensome. Any provider confronted with a DEA Form 832 or a DEA Form 104 should contact an experienced attorney to assist the provider in reviewing their options and determine their potential exposure or liabilities if an inspection were completed.

Can a Provider or Pharmacy Challenge the Results of an Administrative Inspection?

The grounds for challenging an administrative inspection or the procedure by which an administrative inspection was conducted are limited and therefore consulting with experienced counsel before agreeing to an inspection is critical because an attorney will be able to effectively navigate this process in coordination with the provider and their staff.

What Happens if the DEA Investigators or Agents Discover Non Compliance During the Inspection?

The level of non-compliance discovered during the inspection will determine what happens following the inspection. Poor record-keeping may result in a technical violation or a private letter of Admonition but it might not rise to the level of a serious violation. On the other hand, evidence of diversion discovered during the inspection might trigger an Order to Show Cause and a probable cause hearing. During that proceeding, an administrative law judge decides whether or not to revoke or suspend the provider’s DEA registration. Evidence of diversion may also lead to a criminal referral to Special Agents within the DEA and to a U.S. Attorney’s Office resulting in a subsequent criminal investigation and prosecution.

Contact the Feldman Firm if you or your business has been the subject of an administrative inspection by the Drug Enforcement Administration.