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DEA Investigations Against Doctors and Pharmacies DEA Letter of Admonition

April 6, 2022 Federal Criminal Attorneys

The DEA typically issues a Letter of Admonition after auditing or inspecting a pharmacy and finding one or more compliance issues. If the issue is minor, the DEA may simply issue a verbal warning. However, if the issue is more serious, it will be memorialized in writing in the form of a Letter of Admonition.

As mentioned above, a Letter of Admonition does not impose any penalties on the pharmacy that receives it. However, it does serve as notice that there are compliance issues that need to be addressed before DEA auditors return for another audit or inspection. The letter also provides an opportunity for pharmacies to respond to any specific concerns raised by the auditors.

What Are Some Examples of Issues That Might Lead to a Letter of Admonition?

There are many different types of compliance issues that might lead to a Letter of Admonition from the DEA. Some examples include:

Failing to keep accurate records; Failing to maintain adequate security; Failing to follow proper dispensing procedures; Failing to follow proper storage procedures; Failing to properly dispose of controlled substances; and/or Failing to comply with state laws and regulations regarding controlled substances.

The specific compliance issue(s) identified in each individual case will determine whether or not a Letter of Admonition is appropriate. In some cases, multiple issues may be identified during an audit or inspection, which could lead to multiple Letters of Admonition being issued at once. However, even if only one minor issue is identified, it could still result in a formal reprimand from the DEA if it is deemed serious enough by auditors or inspectors.

What Are the Consequences of Receiving a Letter of Admonition?

As mentioned above, a Letter of Admonition does not impose any penalties on the pharmacy that receives it. However, it does serve as notice that there are compliance issues that need to be addressed before DEA auditors return for another audit or inspection. The letter also provides an opportunity for pharmacies to respond to any specific concerns raised by the auditors.

If a pharmacy fails to address the compliance issues identified in a Letter of Admonition, it could face more serious consequences in the future. For example, if auditors or inspectors identify the same issue during a subsequent audit or inspection, they may issue a Notice of Violation (NOV). A NOV is a formal notice from the DEA that outlines specific violations and provides an opportunity for pharmacies to correct them within 30 days. If pharmacies fail to correct the violations within this timeframe, they could face civil or criminal penalties.

How Should Pharmacies Respond to Letters of Admonition?

Pharmacies that receive Letters of Admonition from the DEA should take them seriously and respond appropriately. In most cases, this will involve conducting an internal review of all policies and procedures related to controlled substances and making any necessary changes or corrections. It may also involve retraining employees on proper procedures for handling controlled substances and keeping accurate records.

After completing this internal review and making any necessary changes, pharmacies should provide written documentation to the DEA indicating that they have addressed all compliance issues identified in the Letter of Admonition. This documentation should be submitted within 30 days of receiving the letter, and it should include specific details about what changes were made and how they will prevent similar issues from occurring in the future.

What is the Process for a Letter of Admonition?

The process for a Letter of Admonition is fairly simple. The Board will send a letter to the pharmacy that has been accused of violating one or more laws or regulations. The letter will include:

A description of the alleged violation(s) and how they were discovered; A request for an explanation from the pharmacy; and A request for any additional information that may be relevant to the case.

The pharmacy will then have 30 days to respond to the Board’s letter. Once the Board receives this response, it will decide whether or not to issue a formal complaint against the pharmacy. If no formal complaint is filed, then no further action will be taken against the pharmacy. However, if a formal complaint is filed, then there will be an administrative hearing before an Administrative Law Judge (ALJ). This hearing is similar to a trial in court, and both sides can present evidence and argue their cases before an impartial judge who will make a final decision on whether or not there was any wrongdoing on behalf of the pharmacy.

What Are Some Possible Outcomes?

As mentioned above, if no formal complaint is filed after receiving a Letter of Admonition from the Board, then no further action will be taken against you or your business. However, if you do receive a formal complaint after responding to your Letter of Admonition, then there are several possible outcomes:

The Board may dismiss the complaint; The Board may issue a formal reprimand; The Board may issue a fine; or The Board may suspend or revoke your license.

What Are Some Possible Defenses?

There are several possible defenses that you can use to defend against any accusations of wrongdoing in your Letter of Admonition. Some of these defenses include:

You did not violate any laws or regulations; You did not know that you were violating any laws or regulations; You did not intend to violate any laws or regulations; There was no actual harm caused by your actions; and/or There were extenuating circumstances that prevented you from complying with the law.

If you have been accused of violating one or more laws or regulations, then it is important to speak with an experienced attorney as soon as possible. Your attorney will be able to help you understand the charges against you, investigate the facts of your case, and develop a strong defense on your behalf.

What Are Some Possible Penalties?

As mentioned above, there are several possible penalties that you may face if you are found to have violated one or more laws or regulations. These penalties include:

A formal reprimand; A fine; Suspension of your license; and/or Revocation of your license.

If you have been accused of violating one or more laws or regulations, then it is important to speak with an experienced attorney as soon as possible. Your attorney will be able to help you understand the charges against you, investigate the facts of your case, and develop a strong defense on your behalf.

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