Handling DEA Action PART VI: What Do You Do if You Receive a DOJ Pre-Filing Letter?

By: Hunter DeKoninck & Scott Brinks

When a DEA registrant receives a letter from DOJ threatening civil monetary penalties under the CSA, it must be treated as a serious event and handled delicately. The CSA provides administrative, civil and criminal enforcement options for non-compliance and pre-filing letters signal to registrants that DOJ is assessing potential civil liability and it often means you have limited time to react before it files suit. Failing to properly respond to these letters may lead to escalated enforcement, higher penalties, or registration suspension/revocation.

Below are various steps registrants should consider taking upon receiving a DOJ pre-filing letter.

1. Immediately Secure Legal Counsel (Preferably With DEA/CSA Experience)

Time is of the essence. Engaging counsel with experience in DEA registrations, diversion control, CSA enforcement, and DOJ civil-monetary-penalty programs is critical. Counsel can help interpret the letter, evaluate exposure, preserve rights, and manage responses. Thus, engage an experienced DEA attorney like DeKo Law and another firm with similar expertise.

2. Understand What the Letter Alleges and What Your Exposure Might Be

The letter should specify the types of alleged CSA violations, which often include:

• Failure to maintain effective controls to prevent diversion of controlled substances or listed chemicals.

• Failure to detect and report suspicious orders (for distributors/manufacturers).

• Record-keeping or reporting violations (e.g., missing prescription documents, improper use of DEA Form 222, incomplete inventory records, failure to report thefts/losses, deficient disposal records).

• Dispensing controlled substances without proper prescription (or without dispelling red flags).

• Inadequate physical controls (e.g., vaults, alarms, employee access) that create diversion risk.

The CSA authorizes civil monetary penalties for each violation (for example, each record-keeping violation or each distribution outside registration) and criminal penalties for “knowing” violations. Understanding your exposure means estimating the possible number of violations, the potential penalty per violation, the time period covered, and whether the facts suggest willful or negligent conduct (which often drives higher exposure).

3. Develop a Strategy for How to Respond

With counsel, develop a response strategy, which should address issues such as:

• Deadline: The letter may give a response deadline (or implicitly begin one). You must track and meet any response date.

• Scope of response: Decide whether to submit a formal written response, request a meeting, provide remedial steps, or propose a corrective action plan.

• Preservation of rights: Ensure you are not waiving rights inadvertently by responding. For example, avoid admitting liability unless so advised.

• Remedial actions: If the letter identifies gaps (e.g., suspicious-order monitoring deficiencies, missing records), you may propose or begin remediation immediately. Demonstrating prompt corrective action often works in your favor.

4. Develop Remediation

Regardless of outcomes, you should use this moment to conduct a review of your broader CSA compliance program. Consider whether controlled substance responsibilities are clear, documented, and supported by management. Review corporate policies to confirm they are aligned with DEA regulatory requirements (for order monitoring, suspicious order reporting, record‐keeping, inventory control, theft/loss reporting, etc.). Ensure you are maintaining a robust training program for your employees. And consider other operations and systems that impact your controlled substance handling, such as computer systems, physical controls, internal audit programs, record retention policies, etc.

5. Consider the Consequences

• Civil monetary penalties (CMPs): Under the CSA, each violation (e.g., record-keeping, distribution outside registration) may trigger a separate monetary penalty.

• Administrative actions by DEA: Even apart from DOJ civil enforcement, the DEA may seek to suspend, revoke or restrict a registration.

• Criminal exposure: If the facts show a “knowing” violation of the CSA, there may be criminal liability.

• Reputational risk: DOJ enforcement exposure can damage brand, operations, investor confidence, and future regulatory relationships.

6. Negotiate and Seek Resolution

Once you’ve responded, remediation is underway, and you’re in dialogue with DOJ, the next phase will be negotiating resolution. Often times negotiations may include a monetary component along with a proposed corrective action plan with milestones, independent audits/monitoring if needed, and reporting obligations. Settlement may also require other trade-offs (e.g., admissions, enhanced oversight).

Conclusion

Receiving a DOJ pre-filing letter under the CSA is a serious inflection point for a DEA registrant. It demands immediate action: legal counsel, an internal response, document preservation, and remediation. But with the right approach—prompt action, genuine remediation, and strong communication—you can manage the risk, negotiate a favorable resolution, and emerge with a more robust compliance posture.