The Drug Enforcement Agency is tasked with ensuring compliance of the Controlled Substances Act and a variety of other laws. Your pharmacy is subject to an audit or inspection at any time to ensure compliance. An audit or inspection can understandably be a stressful time for a pharmacist. Concerns about facing civil or criminal penalties related to errors, the possible revocation of your subscription and other matters are common. What should you know about DEA audits?
The DEA’s Primary Focus
The United States is in the midst of an opioid epidemic, so curbing the epidemic is a top priority of the DEA. As a result, the typical DEA pharmacy audit will involve close examination of related controlled substances. Some of these are hydrocodone, oxycodone, clonazepam, codeine, morphine, lorazepam and others. While these controlled substances will receive ample attention from the DEA, they are not the only focal point of a DEA audit. In fact, these are a few of the leading issues that are identified during a pharmacy audit.
1. Intentional or negligent non-compliance with Schedule II controlled substances like methadone, fentanyl, methamphetamine and others
2. Intentional or negligent non-compliance with Schedule III controlled substances like ketamine, Vicodin, anabolic steroids and others
3. Intentional or negligent non-compliance with Schedule IV controlled substances like triazolam, clonazepam, midazolam and others
4. Suspicious dispensing patterns related to statistics for new patients, patients with frequent refills, chronic pain patients, cash-paying patients and others.
5. Relationships with physicians who are suspected of violating regulations related to controlled substances.
6. The pharmacy’s business practices related to why patients fill their prescriptions there, how far they travel and who their referring physicians are
7. Poor compliance controls for drug ordering, packaging and transferring controlled substances, keeping records, preventing theft, dispensing and more
Best Practices During a DEA Pharmacy Audit
The Drug Enforcement Agency has extensive power and reach, and they have the right to audit any pharmacy at any time. Generally, these audits are routine, but the DEA will actively look for red flags that signal the need for a deeper investigation. One of the best steps that you can take to protect your business and yourself is to consult with an experienced legal team. Without representation, individuals may make innocent mistakes that can lead to large investigations and allegations that have far-reaching consequences. With this in mind, the best time to consult with a lawyer is as soon as an audit begins.
The Need for Representation for Routine Audits
If you believe that you have done nothing wrong, you may not see the reason for hiring an attorney. However, even something as simple as a clerical error or a misstatement from one of your staff members could trigger a much more in-depth investigation and the potential for serious allegations. A minor mistake could have significant consequences, and you want to have full legal representation before issues arise. In some situations, legal representation may actually help you to avoid significant issues from developing at all.
A Search Without a Warrant
While other law enforcement agencies are required to obtain a search warrant before proceeding with an investigation in your place of business, this is not the case with the DEA. The DEA is only required to obtain a search warrant if it is participating with other law enforcement agencies. For a general or routine audit, a warrant is not needed. However, this does not mean that the DEA will not find evidence of criminal activity. If a warrant is not obtained, the DEA will use a Form 82, which is a Notice of Inspection of Controlled Premises. Without a warrant, the DEA will need to obtain your informed consent. With this in mind, receipt of notification is the time to consult with an attorney.
Schedule a Legal Consultation Today
Whether you have received a Form 82 or a search warrant has been issued, the time to request legal counsel is now. Contact our law firm today to learn more about your rights and to obtain the representation that you need.
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