The DEA conducts regular inspections to check the compliance practices of registrants that are licensed to have controlled substances in their possession. Find out what to expect during such an audit.

The U.S. Drug Enforcement Administration (DEA) is charged with executing the provisions of the Controlled Substances Act to ensure that the scheduled drugs are handled appropriately and there is no diversion, trafficking or other illicit use. Accordingly, it is empowered to make periodic unannounced inspections to audit pharmacies, laboratories and other locations that are registered for storing controlled substances.

The inspection officers will scrutinize everything from the controlled substance license registration, security, storage and recordkeeping to how the facility transfers and disposes off the scheduled drugs.

How it works?

The registrant is presented with a DEA Form 82 which requires giving informed consent before the inspection can begin. In case of refusal, this can be followed by an inspection warrant. During the audit, the DEA can check any of the following:

• Controlled Substances license and DEA Registration certificate
• Authorized personnel log including screening statements. They may even interview the staff about the policies and activities at the location.
• Procedures regarding security, ordering, storage and administration of controlled substances.
• Procedures for checking if the prescriptions are valid and investigating illegitimate or unnecessary prescriptions before dispensing the scheduled drugs. Even patterns of filling prescriptions for controlled substances may be investigated in detail.
• Records of purchase and other invoices including the proper forms for ordering from licensed or registered distributors and suppliers.
• Making appropriate and timely response to any concerns of counterfeit medications or unlawful diversion of controlled substances.
• Reports of breakage/spillage and theft/significant loss of scheduled drugs. Particular attention will be paid to documented discrepancies.
• Latest inventory statements as well as general and usage logs, etc. They will track usage from the last inventory check or purchase invoice by physically counting or weighing the drugs that are on the site.
• Transfer procedures and disposalrecords. Improper drug disposal is considered a serious offence by the facility even if it has been outsourced to another party.
• Who has access to controlled substance storage locations and how it is monitored.

In case the DEA audit returns a non-compliance report, it can lead to administrative action or even criminal prosecution. This can culminate in a letter of admonition, hefty monetary fines, revoking the license or even a prison sentence.

This is why DEA registrants should always be prepared for an audit inspection and know their rights during the same. They are advised to consult an attorney before consenting to the inspection and understand the legal scope of the audit.

Yet, undergoing a DEA inspection is quite an intimidating and challenging experience. And the consequences of even an unintentional violation can be disastrous. This is why pharmacies will be better off engaging professional experts who will not only prepare the facility for the audit but also streamline the processes, take care of the, say, veterinary DEA license and other requirements, etc. It makes sense to connect with a service provider right away!