Pharmacies, hospitals and any other registrant of the DEA who handles controlled substances could be subject to an audit by the DEA. When a registrant fails such an audit, it could be subject to administrative actions, criminal prosecution and more. The DEA registration can be lost if any violations of the Controlled Substances Act (CSA) are discovered. The impact of mistakes or not understanding regulations can be severe. It is recommended that an attorney is contacted immediately when notification of a DEA audit has been received. This proactive approach is an effective way to avoid problems that could result from such an audit.
Chances Of Audit
There are a number of factors that will contribute to DEA registrant receiving an audit. There are some situations that get more attention than others. The list of registrants to be audited is determined annually by the DEA. These lists can be quite extensive. It is the goal of every local DEA office to complete their audit list by the end of the year. The local DEA office is evaluated by the Office of Diversion Control for their rate of audit completions. There is an unwritten prioritization when it comes to determining who should receive an audit. Any registrant who has previous issues with DEA noncompliance will receive serious consideration for an audit. The DEA will focus on those who prescribe high amounts of buprenorphine and other specific drugs. A physician who utilizes drugs to help patients addicted to opioids will also get attention. The next type of registrant to get attention is someone involved in a practice that involves providing pain medication. Another are physicians who have a practice that involves dispensing or administering drugs instead of just prescribing them. Registrants who don’t prescribe buprenorphine and only write prescriptions for it could get the less attention from the DEA.
Warrants and Notices of Inspection
These are not searches designed to contribute to criminal proceedings. The DEA is not required to have a search warrant to conduct a DEA inspections or confirm compliance with the CSA. Should the DEA inspection be part of a criminal investigation against another governmental agency, a search warrant will be required. The inspections conducted by the DEA are done by diversion investigators. They work in different field offices around the United States. They are usually part of the Diversion Control Program operated by the DEA. An audit starts when a company is presented with DEA form 82, Notice of Inspection of Controlled Premises or an administrative inspection warrant.
Essential Record Keeping
One of the best way to avoid any type of problem when a DEA audit is to make certain all records that must be kept are in compliance with applicable regulations. These records and how they are to be maintained are explained in detail in the regulations. When is comes to a dispensing physician, it includes a dispensing log that contains the names and addresses of patients being given or prescribed medication. The amount of drugs dispensed as well as the date they were dispensed. The original acquisition invoices involving controlled substances that a registrant has taken into their office used as stock as well as the date the controlled substances were received must be recorded. The beginning inventory of all controlled substances available in an office, and any new inventory for the past two years needs to be recorded. Should a registrant be dispensing or prescribing buprenorphine, the registrant must maintain a separate patient specific record. They must also maintain copies of all of applicable written prescriptions. All of these records and more must be properly maintained for a minimum of two years from their creation.
The DEA is very dedicated to making certain regulations are followed. There is no level of leeway and every detail is examined. Should a registrant discover records that are not properly maintained, they can issue an audit report showing noncompliance. This could result in recommendations for disciplinary actions to be taken. It could involve a referral to the United States Attorneys Office for fines as well as criminal prosecution. Should a registrant knowingly not keep, make or furnish any record required by regulation, they could be given up to a year in prison as well as a fine of up to $100,000. Should the failure be determined to be negligence and a civil violation, it could be punished with $10,000 for each occurrence. The consequences for failing a DEA audit will vary based upon the determined level of noncompliance.
There is nothing a registrant can do to prevent a DEA audit. It’s possible for an audit to be initiated randomly or because of a complaint. It is recommended a registrant contact legal counsel when notified of an impending DEA audit. These legal professionals will know how to answer questions and make certain records are properly maintained. Legal counsel will help protect a registrant’s rights during the entire audit process and more.
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