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For a pharmacy or pharmacist, few things are more stressful than a DEA pharmacy audit. When this happens, individuals who are in charge often ask what the worst-case scenario is for such an audit. The short answer is that it is possible to lose a license and spend time in prison. However, that is not always the case. There are often other outcomes instead, which will be discussed shortly.
The outcome of each case depends on a variety of factors, including how well a pharmacy cooperates with a defense attorney who handles the matter. Since the DEA is a federal entity, it is important to quickly find an attorney who works with federal matters and understands federal drug laws that relate to running a pharmacy.
Some people mistakenly think that an investigatory visit from the DEA is simply a minor investigation or involves the DEA asking a few questions. Unfortunately, it means that the DEA is there to conduct a full investigation with the intent of uncovering any and all statutory violations. If the investigators find any, they will certainly take them seriously. These are some potential outcomes of a DEA pharmacy audit.
This is the and most desirable outcome. If a pharmacy is not violating any laws and passes the audit, the DEA ends the investigation. However, it is still wise to retain legal counsel during the investigation.
When there is a significant error rate or suspicious activity, the DEA may ask the pharmacy to surrender its license voluntarily. This often happens when there are suspicious activities involving opioids. In some cases, it may not be advisable to surrender the license. This does not apply in all cases, and it is essential to have an attorney who understands the laws provide direction in such a matter.
If the errors that were made were not severe, a letter of admonishment may be issued. The letter highlights the errors or problems and notifies the licensee of a probationary period. While on probation, a pharmacy must ensure full compliance of all regulations. The DEA will return to conduct a follow-up assessment after it issues a letter of admonishment. Unless it finds additional or more severe problems, there are no suggestions of criminal or civil charges. If no improvements are made during probation, the DEA may revoke the pharmacy’s registration.
When the DEA’s investigation findings show that a pharmacy or pharmacist may pose a danger to the public by staying in operation, it may suspend a license. This may happen when there are large volumes of substances with a high potential for abuse missing.
If the DEA requests that a pharmacy voluntarily surrender its license, and the pharmacy does not comply, it may revoke the registration. In some cases, this process is more beneficial to the licensee since it provides time to argue a case and present information. However, that is not always the case. It is imperative to have a good federal defense attorney handle matters when the DEA tries to revoke a license forcibly.
One of the most important reasons to retain an attorney as soon as there is an investigation is because the DEA will not tell a pharmacy that it is filing criminal charges. If the DEA finds evidence or reasonable suspicion of criminal activity, it will seek criminal prosecution. This typically only happens in extreme cases.
If there is no criminal activity, but there is significant enough evidence of other violations, the DEA may seek civil litigation. There are typically fines involved as penalties. Civil litigation that involves a pharmacy staying in operation during litigation is rare.
If you or your pharmacy is facing a DEA audit, we are here to assist you. Our attorneys know how to help you through the investigation and deal with any outcome appropriately. Please contact us for a consultation.