The Drug Enforcement Administration (DEA), which was established in 1973, is the federal agency that is responsible for the enforcement of laws and regulations related to narcotics and controlled substances. Pharmacies and other businesses that administer, dispense, or supply controlled substances are required to register with the DEA.
Periodically – and at random – the DEA will conduct an inspection of a pharmacy in order to ensure the pharmacy is compliant and following required regulations under the Controlled Substances Act (CSA). These inspections – referred to as audits – typically take place every three years or so. However, there are situations where the DEA may decide to conduct an audit, such as receiving information of potential irregularities.
If you have been notified that your pharmacy is under a DEA audit, the following steps can help you prepare.
Preparing Your Pharmacy
One of the most important steps you can take is to always make sure you are compliant with the CSA. This way, your pharmacy will always be prepared for an audit, even a surprise one.
Some of steps every pharmacy should put in place include the following:
Have detailed policies and procedures in place for responding to a DEA audit.
Have controlled substances policies in place to ensure your business is in DEA compliance. Make sure to review those policies on a regular basis.
Have one employee, along with a backup employee, that is in charge of managing controlled substances policies.
Keep all controlled substances in one, easy-to-access and secure location. All controlled substances should be returned to this secure area at the end of the business day.
Make sure that all controlled substances that will be destroyed are properly recorded.
Make sure to conduct regular inspections of all security measures involving the storage of controlled substances.
Make sure to report any suspicious customer orders.
Conduct mock DEA audits in order to identify any compliance issues that could impact the result of an actual audit.
Where Will the DEA Look?
Many DEA inspectors are laser-focused on a pharmacy’s recordkeeping and security measures during an audit. When it comes to recordkeeping, ensure that all of your pharmacy’s inventories, invoices, logs of use and disposal, and Form 222’s (DEA form used when transferring Schedule II Drugs) are complete and accurate.
Your pharmacy’s security measures that will be examined include how the controlled substances are stored and who has the authorization to access them.
Contact an Illinois Pharmacy Audit Attorney for Legal Help
If you have been notified of an upcoming DEA audit or have been notified that thee were issues with an audit already done, contact an Illinois DEA pharmacy audit attorney right away. Call The Law Offices of Joseph J. Bogdan, LLC at 630-310-1267 to schedule a free and confidential consultation.