Our attorneys help with DEA audits, and inspections, of pharmacies nationwide

The DEA oversees all matters related to controlled substances in the USA. It regularly conducts investigations that are intended to stop the unlawful distribution of drugs. The DEA looks at pharmacies as major hubs of drug diversion and drug trafficking. It regularly audits pharmacies in order to ensure that procedures are being followed. The DEA will investigate pharmacies based on suspicious activity, or reports, of unlawful dispensing of controlled substances. Pharmacies, and pharmacists, are advised to get the help of a DEA defense lawyer who can help them with their DEA audit/inspection/investigation.

The Spodek Law Group can help with all types of legal situations you may find yourself involving DEA registration, professional licensing, audits, and more.

There are many issues that are part of any DEA pharmacy inspection. Before the DEA does an audit, or inspection of your pharmacy, it has to receive informed consent from the holder of a DEA certificate of registration – or it has to get an administrative search warrant. Before consenting to an investigation, a registrant should speak to an attorney who can advise them of their rights – and make sure they understand what the DEA is allowed, and not allowed, to do.

DEA investigations will usually be focused on potential violations surrounding the dispensing of controlled substances. Investigations can address things such as:

• Ordering of controlled substances
• Inventory management
• Prescription fraud monitoring
• Security of the drugs at the pharmacy
• Transfer and disposal of controlled substances

Things to do when facing a DEA investigation

There are a few ways you can respond to a DEA investigation. You can ignore the DEA investigation, or comply with their demands. By hiring a DEA defense attorney, you can work to slow down the investigation – and also, ensure, that investigating agents don’t overreach. You can avoid potential pitfalls, with the DEA defense attorney acting as a barrier and preventing any acceleration in the case.

When involved in a DEA investigation, one of the most important things to do is determining the scope of the investigation. DEA investigations can target a broad array of offenses. In order to ensure your pharmacy gets the right defense, it’s important to understand the scope of the inquiry. Our defense lawyers can help you determine why the pharmacy is being targeted:

• Stark kickback statute violations
• DEA registration issues
• DSCSA violations
• Prescription fraud
• Inventory/Storage/Disposal recordkeeping violations
• Medicare/Medicaid billing fraud
• Money laundering
• Mail fraud
• Wire fraud
• Opioid diversion

It’s important to understand and identify what triggered the investigation. In addition to determining the scope of the investigation, it’s critical to determine what triggered the investigation. Is the DEA doing a routine inspection? Is there a whistleblower who contacted the agent? These are all different situations – and they require different strategies. One of the first things you should consider doing is conducting an internal risk assessment. When the DEA is looking at your pharmacy, you need to know what/if anything the DEA might find. It’s critical you conduct this audit by your pharmacy’s DEA defense lawyers so that the attorney-client privilege applies to any findings from this audit. After you conduct the audit, you have to look at the results. If there are deficiencies in your compliance efforts, then you need to fill those gaps.

The next step after reviewing the results of your internal pharmacy risk assessment audit is to formulate a strategy. Your defense strategy has to address all the allegations in the investigation. If you are the target of a DEA investigation, you have to be very careful about what you say and do. Your DEA defense attorney is critical in this process – because he/she can tell you what to do, and not to do. Once you have an understanding of the scope of the DEA’s investigation, you can then understand what potential there is for charges to be filed against you.

Once your pharmacy is in the DEA’s crosshair – the best thing you can do is hire a DEA defense attorney.