Handling DEA Action PART III: What to do When You Receive an LOA.

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:

• Understand the types of DEA personnel they will encounter

• Handle DEA inspections

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

• Respond to LOAs

• React to MOAs

• Defend against OTSCs

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

For practitioners, pharmacies, hospitals, distributors, and other registrants, receiving any letter from DEA can be quite unsettling. One such communication registrants may face is a Letter of Admonition ("LOA")—a formal notification from the DEA indicating that a violation has occurred, but stopping short of imposing immediate legal penalties. While not as severe as an MOA, order to show cause or immediate suspension order, LOAs should never be taken lightly.

In this post, we’ll break down what an LOA is, why it matters, and—most importantly—how registrants should respond to protect themselves and their DEA registrations.

What is an LOA?

A LOA is an official warning from the DEA issued to a registrant who has allegedly violated the Controlled Substances Act (CSA) or DEA regulations. It is not a punitive measure in itself (such as a fine, suspension or revocation) but, rather, it is an enforcement tool used to:

• Notify the registrant of a regulatory violation;

• Warn against future similar conduct;

• Establish a written record of the infraction.

  
  

The DEA typically issues these letters after an inspection, audit, or investigation. While they may seem like a slap on the wrist, they can have long-term consequences if not handled properly.

What Causes DEA to Issue an LOA?

Some of the most common scenarios that lead to an LOA include:

• Improper recordkeeping (e.g., discrepancies in controlled substance inventory);

• Failure to properly secure controlled substances;

• Prescribing or dispensing errors;

• Failure to comply with registration renewal requirements;

• Technical violations that don’t rise to the level of criminal behavior.

  
  

Even seemingly minor administrative lapses can prompt an LOA, especially if they suggest systemic issues or ongoing noncompliance.

Why Do LOAs Matter?

While an LOA does not result in immediate disciplinary action, it becomes part of your DEA file with the local DEA field office. That means:

• It will be referenced during future inspections to confirm corrective measures have sufficiently addressed the issue;

• It can be considered in future enforcement actions;

• It may influence the DEA’s decision to renew or revoke your registration;

• It could be cited in licensing board investigations or civil litigation;

• It may be accessible in Freedom of Information Act (FOIA) requests or regulatory disclosures.

  
  

In short, LOAs become a red flag in your compliance history—so downplaying its significance can be risky.

How Should a Registrant Respond to an LOA?

Registrants should be sure to take the following steps upon receiving an LOA:

1. Read the LOA Carefully

Understand what violations the DEA is alleging. Review all regulations or statutes cited in the LOA and determine what regulatory requirements are at issue. Review the LOA for any factual errors or misunderstandings that need to be clarified with DEA. Finally, note any deadlines for responding to the LOA and request an extension from DEA if one is needed.

2. Consult Legal Counsel Immediately

Don’t respond alone. Reach out to an attorney who specializes in DEA compliance so they can:

• Interpret the LOA;

• Assess the seriousness of the allegations;

• Prepare an appropriate response;

• Advise on corrective actions to take.

  
  

3. Respond in Writing

While the DEA does not always require a formal reply, it is often wise to respond—especially if you disagree with the findings or want to document corrective actions. Written responses should:

• Clarify facts or provide context;

• Confirm that you understand your regulatory obligations;

• Assure DEA that you take its concerns seriously;

• Demonstrate it is your goal to come into compliance;

• Describe corrective measures that have been implemented or will be implemented.

  
  

4. Implement Corrective Actions

Even if the violation seems minor, take concrete steps to address it. This might include:

• Updating policies and procedures;

• Conducting staff training;

• Improving recordkeeping systems;

• Tightening security around controlled substances.

  
  

Document all changes made and keep records of training or compliance audits.

5. Prepare for Future Scrutiny

Once you’ve received an LOA, you may be subject to more frequent inspections or heightened scrutiny, so be proactive and:

• Consider whether to engage the right DEA consultant to advise on other potential compliance gaps;

• Conduct regular internal audits;

• Keep meticulous records;

• Stay current with DEA rules and guidance.

  
  

If another issue arises, your original response to the LOA could be reviewed—so it’s essential to show that you took the matter seriously.

Final Thoughts

Receiving an LOA from DEA may not be the end of the world—but it is a serious compliance signal. How you respond can shape your relationship with the DEA for years to come. By working with the right DEA counsel and/or DEA consultants, addressing the root causes of the violation, and demonstrating a strong commitment to compliance, you can mitigate the risks and move forward with greater confidence.

If you’ve received an LOA or have questions about DEA compliance, don’t wait to seek guidance. The right response today can prevent much bigger problems tomorrow.

Co-Authors:

Hunter DeKoninck is the owner of DeKo Law. He is an attorney specializing in DEA compliance.

Scott Brinks is the owner of Brinks Consulting. He is a DEA consultant, leveraging expertise developed during his 28-year career with DEA.