Handling DEA Action PART II: How To Handle Routine Cyclic Inspections?

By Scott Brinks & Hunter DeKoninck

This post is part of a 7-part blog series designed to outline various types of DEA enforcement action registrants need to understand and prepare themselves for. This series will discuss how registrants should:

·       Handle DEA inspections,

·       Engage bad DIs (or DIs who misunderstand/misapply DEA’s regulations),

·       Respond to LOAs,

·       React to MOAs,

·       Defend against OTSCs and

·       Engage DOJ after receiving a pre-filing letter threatening civil action.

If you are a DEA registrant—whether you're running a pharmacy, clinic, or any facility handling controlled substances—it's essential to be prepared for DEA inspections. DEA Diversion Investigators (“DIs”) will arrive unannounced and how you (and your employees) react to their arrival and how you conduct yourself throughout their visit will often influence the investigation’s outcome.

This post is intended to serve as a general reference tool for handling DEA inspections under different legal authorities: Notice of Inspection (NOI), Administrative Inspection Warrant (AIW), and Criminal Search Warrant. However, it is important to realize that every inspection is different and each one presents its own unique risks and potential exposure for registrants. If you are a non-practitioner (e.g. a distributor, a repackager), you can expect a robust and in-depth review of your sensitive SOM systems and a review of your high-volume customers, so it is critical to handle these inspections with great care. Similarly, if you are a practitioner (e.g. a physician, a pharmacy, a veterinarian, a clinic), there is often a specific reason for why your local DEA division and field office has selected you for an inspection, so it is especially important to exercise much caution with these visits.

Accordingly, use this post (and other resources like it) and coordinate closely with your in-house and outside counsel to ensure you are prepared for the next inspection.

Initial Arrival Protocol

When DIs arrive:

• Stay calm and professional, DIs are required to identify themselves and show you their DEA Credentials.

• Escort Immediately: Guide DIs directly to a designated conference room. They should never roam the facility unescorted, including to the restroom.

• Activate Your Response Team: Only your pre-approved internal team should interact with the DIs.

• Notify Staff: Let everyone know DEA is onsite. No one should speak with the DIs unless part of a scheduled interview.

• Protect Privacy: Instruct staff to close office doors to maintain confidentiality and limit visibility.

If They Present a Notice of Inspection (NOI)

An NOI is a request for voluntary consent to inspect your premises. It’s not a warrant, and you have the right to refuse. DIs can serve NOIs, DEA Special Agents do not have the authority to serve an NOI.

Important Clarification About NOIs: Only DEA Diversion Investigators are authorized to conduct inspections under a Notice of Inspection (NOI). If other federal or state agency personnel accompany the DI, it’s essential to verify that they are operating under their own independent authority. If they are not, you have the right to ask them to leave the premises. Always ensure that the scope of the inspection is limited to what the DI is legally permitted to conduct under the NOI.

Key Points:

• DIs are required to present and explain the Notice of Inspection (NOI) before proceeding. Consent must be given by signing the NOI, and the individual signing on behalf of your organization should have the proper authority to do so.

• There is no set time limit for a DEA inspection to be completed. Records must simply be readily retrievable—not immediately produced. Take your time gathering the requested documents, and ensure you only provide records that are specifically asked for and required to be maintained under DEA regulations.

• Under an NOI, the only records that should be provided electronically are Electronic Prescription Records and Controlled Substance Ordering System (CSOS) records. All other documents should be supplied in paper form, unless otherwise legally required.

• DIs may only review records required to be kept.

• DIs must remain in the conference room unless they leave the premises or are escorted.

• Requests for additional documents must go through a subpoena.

• They may inspect required security measures only—do not allow access to non-required features.

• If DIs request copies of your standard operating procedures (SOPs), be aware that these are not records required to be maintained under DEA regulations. Before providing any SOPs, consult with legal counsel to determine whether disclosure is appropriate.

Your Rights:

• NOIs must be conducted during normal business hours.

• You do not have to sign a NOI.

• You can revoke consent and end the inspection at any time.

• You do not have to answer any questions.

Business Continuity:

• DIs do not have the authority to interfere with your business operations or shut down your facility during an NOI inspection. If they attempt to do so, you should immediately revoke your consent to the inspection, ask them to leave the premises, and contact your attorney without delay.

If DEA Presents an Administrative Inspection Warrant (AIW)

An AIW is a court order allowing DEA to inspect your registered location. It’s not a criminal search warrant and has limited scope. DIs and DEA Special Agents can serve AIWs.

Key Points:

• DEA must provide you with a copy of the AIW signed by a judge.

• Investigators may be accompanied by law enforcement, but their authority is still limited.

• You are required to provide the records listed in the warrant, but DEA is not authorized to search for them.

• When presented with an AIW, gather only the records specifically listed in the warrant. Do this in a separate room away from DEA investigators to allow for careful review. Double-check the documents to ensure you are only providing what is explicitly requested. Make copies of all the records and deliver them to the DEA agents in a single, organized batch.

• Under an AIW, the only records that should be provided electronically are Electronic Prescription Records and Controlled Substance Ordering System (CSOS) records. All other documents should be supplied in paper form, unless specifically ordered in the AIW.

• Escort them to the conference room and keep them there.

• Additional documentation must be requested via subpoena.

• They may inspect only required security measures.

Your Rights:

• The AIW must be conducted during normal business hours.

• They do not have the authority to search your facility or walk around unescorted.

• You do not have to answer any questions.

Business Continuity:

• DEA personnel operating under an AIW are not authorized to interfere with your business operations or shut down your facility. Their authority is limited to inspecting records and security measures as outlined in the warrant.

If They Present a Criminal Search Warrant

This is a serious escalation. A criminal search warrant is issued based on probable cause of a violation of law. DEA Special Agents are authorized to serve criminal search warrants, whereas DIs are not.

What to Do:

• Allow investigators to secure the location and conduct the search.

• Do not answer any questions or engage in conversation.

• Request a copy of the search warrant and review it carefully.

• Contact your attorney immediately.

• Instruct staff to remain silent and avoid any interaction with investigators.

Final Thoughts

DEA inspections can be routine or part of a larger investigation. Knowing your rights and having a clear protocol in place ensures you're prepared to respond professionally and legally. Whether it's an NOI, AIW, or criminal search warrant, your priority should be to protect your business, your staff, and your legal standing.