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Last Updated on: 28th July 2023, 07:21 pm
The Drug Enforcement Administration (DEA) is the primary federal agency responsible for investigating illegal drug activity, including trafficking Schedules I and II substances such as heroin or cocaine. DEA Audit and Investigation They routinely conduct audits on pharmacies to ensure compliance with the Controlled Substances Act (CSA), which is why healthcare business owners must always stay prepared for a potential DEA pharmacy audit. Due to the opioid crisis, pharmacies are increasingly “red-flagged” by the DEA for investigations over opioid transactions. You could lose your license or face felony federal criminal charges if you discover intentional or unintentional wrongdoing.
The DEA is relentless in their pursuit of ensuring pharmacies comply with the CSA, and it’s no secret that they conduct routine inspections and audits to ensure adherence. With the opioid crisis in full swing, pharmacies have become a prime target for investigations over opioid transactions. The stakes are high, and a violation can result in severe consequences, including the loss of your license, hefty fines, and even federal criminal charges.
If you’re under investigation by the DEA, you must retain experienced legal counsel to guide you through the process. It would be wise to have counsel for help with audits and inspections. By getting legal representation early in the process, you are increasing your chances of a favorable outcome. Our California criminal defense lawyers will examine this topic further below.
WHAT SPECIFICALLY HAPPENS DURING A DEA AUDIT? The DEA performs routine inspections and audits of medical and pharmaceutical practitioners to ensure they comply with the CSA. These audits are regular, but administrative action can be taken against you for any violations. When this happens, your DEA registration may be negatively affected, which is why you need to ensure you comply with federal laws and regulations. These inspections usually happen once every couple of years or more often if the medical practitioner prescribes buprenorphine or other drugs to treat heroin addictions. A pharmacy must meet the requirements of the DEA audit to keep operating its business.
DEA diversion investigators perform DEA inspections and audits, usually part of the DEA’s Diversion Control Program. A DEA audit will begin when a DEA Form 82, a “Notice of Inspection of Controlled Premises,” or an administrative inspection warrant is given to a DEA registrant before the inspection. Suppose the DEA audits your prescribing or dispensing records. In that case, you should expect a request for a significant amount of documents, such as patient files, medical records, or financial records dating back many years. The DEA investigators could interview you and your staff about prescribing or dispensing practices. If they discover CSA violations, they could take administrative or criminal action.
ADMINISTRATIVE SEARCH WARRANT – EXPLAINED If you decline to submit to the inspection, the DEA will secure an administrative search warrant from a Federal District Court even without probable cause. If they are investigating suspected criminal activity, then they have to obtain a search warrant before they can search for your practice. DEA Administrative Search Warrant To get an administrative search warrant, they must describe in detail the nature and extent of the inspection and any items seized. Federal court judges offer little to no resistance and routinely grant administrative search warrants.
Once the DEA presents an administrative search warrant for an audit or inspection, then you must comply. If you decide to refuse, you could face arrest. Readers should note that an administrative search warrant doesn’t give the DEA authority to inspect all aspects of your practice, but they are allowed to interview employees, which could be used against you. If they discover non-compliance, they will write up and issue an audit report with the details.
When it comes to prescribing and dispensing controlled substances, the DEA is always on the lookout for anomalies or “unusual” activities that may be in violation of the United States Controlled Substances Act (CSA). But what exactly could trigger a “red flag” and lead to increased scrutiny and potential legal action?
Some common red flags include a doctor prescribing an excessively high amount of Schedule II prescriptions compared to other types of drugs, a pharmacist filling a large number of opioid prescriptions from the same doctor, a high number of cash payments for opioid prescriptions, inventory irregularities, and failure to follow proper security protocols for storing or disposing of certain controlled substances. Even something as seemingly insignificant as failing to bill insurance companies for your services or having patients routinely travel long distances to visit your medical practice could raise red flags.
But there are steps you can take to minimize your risk of being flagged or investigated by the DEA. For example, keeping detailed records of all your opioid transactions, regularly examining your prescribing and dispensing practices, training your employees on CSA compliance, reporting suspicious activity to the DEA, and conducting regular “self-audits” for CSA compliance can all help you stay on the right side of the law.
If you do find yourself facing a DEA audit or investigation, it’s crucial to consult with a qualified lawyer as soon as possible. The DEA takes these matters very seriously and even accidental violations can result in significant penalties. A lawyer seasoned in DEA defense can significantly reduce your risk of further punitive actions and ensure that your rights are protected throughout the process.
So, whether you’re worried about being flagged by the DEA or you’ve already been notified of non-compliance or indicted for CSA violations, don’t hesitate to contact our law firm for expert legal guidance and representation. We are experienced in handling DEA investigations and enforcement actions and will work tirelessly to protect your rights and defend your interests. Don’t speak to the DEA without contacting us first, we can ensure that the DEA investigators don’t exceed the scope of their search warrant or legal authority under a DEA Form 82 inspection.
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