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Blog
What to Expect When You're Inspected
IQVIA experts reveal how the marketplace has changed through the lens of omnichannel marketing
Nov 19, 2020
If you manufacture, store, or distribute controlled substances, the DEA will inspect your facility to ensure compliance and accountability. These visits are typically unannounced, and if you are not prepared, it could lead to closures, stiff fines, and even criminal action. But if your controlled substances program adheres to the Four Pillars of DEA Compliance – proper registration, sound record- keeping, accurate reporting, and effective security controls, you will be in good shape to survive these inspections with minimal after-action items.
Get ready
The best way to be prepared for a DEA inspection is by managing your compliance program as though an inspector could show up at any time. That means keeping all records up-to-date, reporting any suspicious activity within 24 hours, conducting periodic background checks of customers and suppliers, and maintaining rigorous security controls on your property and technology platforms.
You don’t want to wait until you receive notification of an inspection to start getting your operation in order, because by that point, DEA investigators will already have reviewed a number of documents about your site.
Prior to the inspection they will have checked your ARCOS status, quotas, DEA registrations, and the results of any prior inspections – including how you handled all prior post-inspection actions. They will also familiarize themselves with you, your company, and your security plan before they ever set foot on the premises. That means you have to be prepared for an inspection before it’s announced, and have all your records and actions in place and documented at all times.
Inspection Day
DEA investigators can enter your facility using a number of different options, depending on their intent. Upon arrival, you will be presented with one of the following:
- Notice of Inspection (NOI) (DEA Form 82)
- Administrative Inspection Warrant
- Criminal Search Warrant
The most commonly used is the NOI, which is presented for unscheduled, unannounced inspections. In these cases, the DEA registrant gives DEA voluntary consent to enter and inspect the registered location without a warrant, and they can withdraw that right at any time. Under an NOI, the DEA may only inspect those records required to be kept under the regulations.
The DEA is mandated to conduct inspections of entities that legitimately handle controlled substances. To ensure access to a registered location, the DEA might obtain an Administrative Inspection Warrant which allows them access to those records required to be kept. It is a narrow scope warrant and the inspection must be conducted during normal business hours. It may be used due to the fact that a site has never had a DEA inspection, or due to other factors such as ARCOS data, theft or significant loss reports, or suspicious order monitoring reports. If it is believed that criminal activity is ongoing, the DEA will obtain a criminal search warrant which allows a broader scope for searching and seizing records.
When the audit begins, the DEA with review all procedural and background information, warehouse schematics, record- keeping data, and the security system. They may find violations at any point in this review process.
The most common cited violations result from failure to maintain complete and accurate records, failure to report theft and significant losses and suspicious orders, and failure to maintain effect controls to prevent diversion. However, there are many fewer common violations, including failure to keep a state license current, making security changes without notifying the DEA, or missing a piece of paperwork or product receipt. It is important to be aware of all of these compliance risks to avoid inadvertent mistakes.
If the inspectors do find violations, first-time offences or minor issues will generally result in verbal guidance or a Letter of Admonition. In more severe cases or for chronic violators, inspectors may require an Administrative Hearing, Order to Show Cause, civil fines, and/or criminal prosecution.
Be prepared
Staying in compliance with DEA regulations is a necessary part of doing business. But it can be confusing and time consuming for busy operations. To mitigate these risks, many facilities work with third-party compliance experts to help them ensure every aspect of their operations will meet DEA requirements, so they can avoid these time-consuming and costly violations.
When choosing a vendor to support your compliance goals, look for an organization that employs former DEA regulators and policy makers who understand the intricacies of DEA inspections and culture. You also want to be sure your vendor can offer secure virtual inspections and remote accountability audits, which are necessary during the pandemic, and can bring efficiency to your operations. Working with an expert will ensure you can maintain a robust regulatory compliance program, and ease any concerns your team has about future inspections.
DEA Compliance for Manufacturers and Distributors in Today’s Virtual Times
Learn more about building a strong foundation for your controlled substance compliance program by viewing this webinar on demand.