DEA audits are a routine affair for every registrant. However, the risks should a non-compliance come to light are very high. It pays to be aware of what the DEA will check and stay prepared accordingly.
Every healthcare practitioner, pharmacy or distributor that is registered with the Drug Enforcement Administration (DEA) for handling controlled substance drugs is well aware that they will face a surprise DEA audit sooner or later.
The terms DEA audit and inspection are used interchangeably on most occasions. They involve an unannounced visit by the DEA authorities to review locations where the controlled substances are stored, dispensed or administered. The overarching aim is to determine whether the facility is in complete compliance with the Controlled Substances Act (CSA) or not.
This is a routine practice and the DEA generally inspects the registrants at random once every three years. They may be more frequent if the provider prescribes buprenorphine and/or has a Drug Addiction Treatment Act of 2000 waiver. Certain non-prescriber facilities are audited once in five years. A tip or suspicion of controlled substance deviation or other malpractice can also invite a DEA inspection.
The fallout of failing a DEA audit can be very severe – from losing the license for administering controlled substances to even a prison sentence. The proactive approach is to understand what to expect during a DEA audit and stay prepared for the same.
What will the DEA Diversion Investigator Look For?
- Review copies of federal and state licenses of the registrant.
- Request updated information about the registrant’s operations, responsible employees, corporate structure, controlled substances handled, and hours of operation.
- May ask for personal information of management and employees with access to controlled substances like home addresses, dates of birth, and social security numbers.
- Security details like who has access to the vault, cage, and safe, system components and specifications, internal inspection results, alarm test results, and central station monitoring contracts.
- May request a list of the registrant’s suppliers and customers.
- May ask for a copy of the registrant’s policies and procedures.
- Check records of at least two drugs in each schedule for a minimum one year period – this will cover the movement of the controlled substances from receipt to sale/transfer/disposal from the facility.
- Controlled substance records and reports for the last two years along with initial or biennial inventories and even year-end inventories on occasion.
- Review invoices, packing slips, patient records, prescriptions, administration/dispensing records, destruction and disposal records, etc. to ensure that they are complete and accurate.
- Review the registrant’s Powers of Attorney to ensure that individuals ordering Schedule I and II substances are properly authorized to do so.
- May even attempt to interview the registrant and/or their staff
Knowing the DEA controlled substance regulations and preparing for the DEA inspection is a tall order. It is considered prudent to engage the services of DEA compliance professionals who will not only ensure that complete and accurate records and reports are ready at all times, but also train the staff to handle a DEA audit.
