What Should I Do if I Receive a DEA Notice of Inspection?

 Posted on January 15,2021 in Pharmacy License Defense

Medical providers that prescribe, dispense, or handle controlled substances are required to follow all applicable laws and regulations related to these drugs. The Drug Enforcement Administration (DEA) monitors providers to ensure that controlled substances are being used correctly, and it may take action to address any potential violations of the law. As part of its ongoing efforts, the DEA often conducts audits and inspections, and providers who have received a Notice of Inspection from the DEA will want to understand their rights and how they can protect themselves from consequences that could affect their DEA registration or their professional license.

Understanding DEA Inspections

The DEA performs regular, routine audits of medical providers that have a controlled substance registration. Inspections may also be performed as part of a larger investigation related to possible drug diversion, including in cases involving reports or claims of unlawful prescribing, unlawful dispensing, or conspiracy to possess or distribute controlled substances.

While the DEA may obtain a search warrant before performing an inspection, in most cases, a provider will receive a Notice of Inspection. This notice will follow a standard form (DEA Form 82), and it will include the name and address of the premises being inspected, the name and title of the owner or operator in charge of the premises, the date and time when the inspection will be performed, and the signature of the person performing the inspection. Typically, a registrant must provide informed consent before an inspection can be performed, and they have the constitutional right to refuse an inspection. Informed consent is given by signing a written statement in which a provider will verify that they understand that the results of an inspection could be used as evidence if the DEA or other law enforcement officials decide to pursue criminal drug charges.

During an inspection, the DEA may do any or all of the following:

• Inspect and copy records and documents related to controlled substances, including inventory records, order forms, prescription or distribution records, and records related to storage or shipping.
• Inspect equipment used to process or dispense controlled substances, including related materials, containers, and labeling.
• Perform an inventory of all controlled substances that a provider keeps on hand.
• Take samples of controlled substances.
• Review records to identify the reasons behind any changes in the provider’s distribution of controlled substances.
• Review any other necessary information (with the exception of sales, financial, or pricing data) to verify records related to the use, handling, or distribution of controlled substances.

Contact an Illinois DEA Inspection Lawyer

If you have received a Notice of Inspection from the DEA, you should be sure to understand your rights, and you will want to take the right steps to avoid any potential consequences that you may face. At The Law Offices of Joseph J. Bogdan, Inc., we can advise you of how you should proceed before and during an inspection, and we will provide you with representation as you deal with the DEA, helping you avoid the loss of your controlled substance registration and address any other issues that could affect your medical license, your practice, or your career. Contact our United States DEA registration defense attorney at 630-310-1267 to set up a free consultation today.

Sources:

https://www.asam.org/advocacy/practice-resources/private-practice/dea-office-inspection-tips

https://www.deadiversion.usdoj.gov/21cfr/cfr/1316/1316_03.htm

https://www.deadiversion.usdoj.gov/21cfr/cfr/1316/1316_06.htm