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Last Updated on: 28th July 2023, 07:23 pm
Being audited by the Drug Enforcement Administration is every pharmacy owner’s nightmare. Unfortunately, it’s a scenario that’s become increasingly common as the DEA cracks down on controlled medication dispensing.
While these in-depth audits are undoubtedly stressful, the worst case scenario is facing severe criminal charges or losing your DEA registration entirely. Here’s an in-depth look at how to navigate a DEA audit to avoid the most serious consequences.
When the DEA shows up to perform an intensive inspection, they are looking for any potential violations of the Controlled Substances Act. Here are some reasons this strikes fear into the hearts of pharmacy owners:
You likely have violations – Even the most diligent pharmacies have likely committed some record-keeping or procedural violations due to the complex regulations.
Mistakes can be deemed criminal – Even accidental errors in dispensing controlled substances could potentially lead to criminal charges.
Penalties are severe – Possible outcomes range from huge fines to federal prison time to losing your DEA registration – essentially killing your business.
The stakes are high – Your personal and business reputation, financial security, and freedom are all on the line.
For these reasons, it’s critical to secure legal guidance when facing an impending DEA audit. Experienced counsel is key to avoiding the worst case scenarios.
Your typical healthcare or business attorney is likely not sufficient in this scenario. You need counsel specifically experienced with DEA matters. Here’s how to find the right lawyer for a DEA inspection:
Search for “DEA audit defense attorney” or “DEA compliance lawyer”. You want someone well-versed in the Controlled Substances Act and DEA enforcement procedures.
Look for former federal prosecutors or DEA agents. Their inside knowledge of the DEA is invaluable in mounting your defense.
Find lawyers located in your state. DEA regulations can vary based on the jurisdiction, so local counsel is key.
Consider boutique healthcare and DEA specialty firms. Unlike massive firms, they offer experienced, personalized guidance through the audit process.
Vet several options. Schedule intro calls with a few qualified lawyers before deciding. Ask detailed questions and go with your gut.
With potential criminal charges looming, diligently researching to get the best defense attorney is a must. Don’t cut corners or try to go it alone.
As you evaluate lawyers, keep these top factors in mind:
1. Specific DEA defense experience. Ask how many DEA cases they have handled and what results they’ve obtained for pharmacies. Look for substantial experience representing pharmacies in your state.
2. Familiarity with pharmacy operations. They must fully understand day-to-day pharmacy workflows, record-keeping, and standard procedures to build the best defense.
3. Negotiation skills. Ideally, they can negotiate with DEA agents directly during the audit to minimize potential penalties. Ask about examples of past settlements they’ve achieved.
4. Trial experience. In worst case scenarios, you want counsel prepared to vigorously defend your case in court if necessary.
5. Comfort level. You need an attorney you feel truly comfortable confiding in, given the risks involved. Trust your gut.
6. Passion for client advocacy. They should demonstrate a sincere commitment to protecting pharmacy clients’ rights and reputations.
Investing time to find the right DEA audit lawyer pays off exponentially in the long run. Don’t wait – get specialized representation on your side immediately.
While extremely stressful, understand that most pharmacies complete DEA audits without facing severe penalties or criminal charges. Still, you should be prepared for various worst case scenarios:
Criminal charges – If serious violations are uncovered, you or key staff could face criminal prosecution. Charges may include drug diversion, health care fraud, misbranding drugs, etc. Your lawyer’s defense and negotiation skills are critical to avoid prison time.
License revocation – The DEA may threaten to revoke your pharmacy’s registration and ability to dispense controlled medications. Fight this aggressively, as it likely will kill your business.
Exclusion from insurance networks – If violations appear intentional, insurance payors may terminate your network contracts. This also harms business dramatically.
Multi-million dollar fines – Even civil fines can become excessive – sometimes millions for large chains. Your lawyer can possibly minimize fines through savvy negotiation.
While daunting, understand these are worst case scenarios. With an experienced attorney’s counsel, most pharmacies can reduce penalties and avoid criminal charges or losing their DEA registration.
To most effectively partner with your lawyer throughout the DEA audit process, remember:
1. Be proactive. Don’t wait for DEA agents to show up unannounced. Have your lawyer do an internal review first to get ahead of potential issues.
2. Be honest. Your lawyer needs to know about any legitimate problems or violations identified internally so they can properly advise and defend you.
3. Follow their lead. During the on-site audit itself, let your counsel take the lead in directly engaging with DEA investigators.
4. Have procedures in order. Make sure your compliance policies, procedures, and record-keeping are as robust as possible before the audit.
5. Prepare staff. Have your lawyer help educate employees on responding appropriately to DEA inquiries.
6. Keep communicating. Maintain constant open communication with your attorney before, during, and after the DEA pharmacy audit.
Remember, your lawyer is there to shield you from the most serious repercussions. So cooperate fully and rely on their counsel every step of the way.
Being targeted for a DEA audit strikes fear into every pharmacy owner. But with an experienced DEA defense attorney guiding you through the process, the worst case scenarios can often be avoided.
Work diligently to secure the right lawyer for your situation before DEA agents show up. Then rely on their strategic guidance and expertise to help control the outcome. While certainly stressful, having strong legal advocacy on your side can make all the difference.
So take a deep breath, do your research, and contact qualified DEA audit defense counsel right away. With their help, you can likely navigate through this challenge and come out intact on the other side. Don’t wait – connect with savvy legal representation now before issues spiral. With the right lawyer by your side, you can overcome this hurdle.
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