The DEA routinely conducts audits of practitioners and pharmacies in order to ensure their compliance with the CSA, and these audits may be conducted at the request of the US Attorney’s Office. The US Attorney’s Office may also request audits in cases where unlawful prescribing or unlawful dispensing of controlled substances is suspected.
During an audit, practitioners and pharmacies will be asked to produce records for review, and these records may include, but are not limited to, the following:
In addition to audits, the DEA may also conduct inspections of medical practices, and these inspections are conducted to ensure compliance with the CSA. During an inspection, the DEA will review the following:
The DEA may also open investigations into medical practices where the unlawful prescribing or unlawful dispensing of controlled substances is suspected, and these investigations may be opened as a result of a complaint. The DEA may conduct interviews during an investigation and may request records for review, and these records may include, but are not limited to, the following:
The DEA may also interview the medical staff during an investigation.
Medical Providers’ Rights During a DEA Audit, Inspection, or Investigation
Medical providers have rights during a DEA audit, inspection, or investigation, and they should take the following steps to ensure their rights are protected:
1. Do Not Speak With the DEA Before Speaking With an Attorney
As soon as a medical practice receives a request for an audit, inspection, or investigation, it should seek legal counsel. Medical practices should not provide documents to the DEA without first consulting with an attorney, and medical staff should not speak with the DEA about the audit, inspection, or investigation without first speaking with an attorney.
2. Do Not Allow the DEA to Search the Medical Practice Without a Subpoena
The DEA cannot search a medical practice without a warrant or a subpoena, and medical providers should not allow the DEA to conduct a search of the medical practice without a warrant or a subpoena. If a medical practice receives a warrant or subpoena, it should provide the warrant or subpoena to legal counsel.
3. Do Not Allow the DEA to Interview the Medical Staff Without an Attorney Present
The DEA cannot interview the medical staff without an attorney present, and medical providers should not allow the DEA to conduct interviews without an attorney present.
4. Select a Designated Representative
Medical practices should designate a representative to speak with the DEA, and this designated representative should be an attorney. The designated representative will be responsible for coordinating with the DEA, and the designated representative will be responsible for ensuring that the medical practice is in compliance with the requests of the DEA.
5. Cooperate With the Request of the DEA
Medical practices should cooperate with the request of the DEA, and medical practices should provide the DEA with any documents that are requested. Medical practices should also provide the DEA with any information that is requested, and medical practices should allow the DEA to interview the medical staff. Medical practices should not provide the DEA with any information that is not requested.
6. Review the Results of the Audit, Inspection, or Investigation
Medical practices should review the results of the audit, inspection, or investigation, and medical practices should take corrective action if any deficiencies are found.
7. Seek Legal Counsel
Medical practices should seek legal counsel when an audit, inspection, or investigation is conducted, and medical practices should seek legal counsel when the results of the audit, inspection, or investigation are reviewed.
If the medical practice is found to be in violation of the CSA, the medical practice may be subject to sanctions, and the medical practice may be required to take corrective action. If the medical practice is found to be in violation of the CSA, the medical practice may also be required to submit to an audit on a regular basis.
Medical Providers Who Fail to Comply With the Request of the DEA
Medical providers who fail to comply with the request of the DEA may be subject to sanctions, and medical providers may be required to take corrective action. Medical providers who fail to comply with the request of the DEA may also be required to submit to an audit on a regular basis.
Contact an Experienced Healthcare Attorney
If your medical practice receives a request for an audit, inspection, or investigation, you need to seek legal counsel immediately. Our experienced healthcare attorneys can help you protect your rights and ensure that you are in compliance with the request of the DEA. For more information, contact our experienced healthcare attorneys today.
If a registrant has questions about the audit, the investigator will refer him or her to a supervisor. The supervisor will answer the registrant’s questions and, if appropriate, provide him or her with a list of the required records. The registrant is not required to provide any information to the DEA that is not listed on the Notice of Inspection, and the registrant has the right to have an attorney present during the audit.
The records requested on a Form 82 will be based on the type of registration. The records that must be made available for review include:
The records must be made available for inspection at the registered location or at another location approved by the registrant. The inspection should not interfere with the normal operation of the registered location.
The inspector will take the time needed to examine the required records. The registrant will be given an opportunity to explain how the records are maintained and how the
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