DEA inspections of healthcare facilities are increasing. Hospitals, surgery centers, and pharmacies are seeing more routine accountability audits, diversion investigations, and cyclic inspections than they did even a few years ago.
If you’re wondering how to prepare for a DEA inspection, you’re not alone. Many facilities assume they are compliant — until an inspection reveals otherwise.
In an expert discussion, we spoke with Susannah Herker, Senior Managing Director at Guidepost Solutions and former DEA investigator with more than 15 years of enforcement experience. Drawing from her time training DEA personnel to investigate Controlled Substances Act violations, she shared firsthand insight into why healthcare facilities continue to struggle with diversion compliance — even when the regulations are publicly available.
Watch the full expert discussion below:
During the conversation, several key themes emerged:
- Why having access to the CFR does not equal compliance
- How DEA interprets “effective controls to guard against diversion”
- Why biennial inventory errors remain common
- What zero-variance accountability really means
- How diversion program strength impacts enforcement posture
This article expands on those insights and outlines practical steps your organization can take now to improve DEA inspection readiness.
Because preparing for a DEA inspection is not about having policies on paper.
It’s about demonstrating operational control when inspectors walk through your doors.
Unsure How Prepared Your Facility Really Is?
Before the DEA tests your compliance, test it yourself.
RXPERT Solutions conducts structured DEA Mock Inspections and Diversion Compliance Assessments designed specifically for healthcare facilities.
👉 Request a Free 30-Minute DEA Risk Assessment
Schedule Your Confidential Compliance Review
No obligation. No pressure. Just clarity.
Why Access to the CFR Isn’t Enough
The DEA makes regulatory guidance publicly available through the official DEA Diversion Control Division website, where registrants can access forms, guidance documents, and enforcement updates.
The regulatory framework governing controlled substances is outlined in 21 CFR Part 1300–1321 within the Electronic Code of Federal Regulations, detailing inventory requirements, security standards, recordkeeping rules, and reporting obligations.
Everything is accessible.
But the problem isn’t access.
It’s interpretation and execution.
Healthcare facilities operate 24/7. Staff turnover happens. Workflows evolve. ADC systems change. Policies are written — but not always operationalized.
When preparing for a DEA inspection, the question is not “Do we have a policy?”
The question is “Can we demonstrate operational compliance under scrutiny?”
The Most Common DEA Inspection Findings in Healthcare
If you want to understand how to prepare for a DEA inspection, start with the areas where facilities most often receive findings.
1. Improper Biennial Inventory Execution
Under 21 CFR §1304.11, registrants must conduct a physical count of all controlled substances at least every two years.
Common errors include:
- Relying solely on ADC electronic counts
- Failing to document beginning vs. end of business
- Not including expired stock
- Inconsistent counting practices across departments
Electronic reports do not replace physical counts.
If your team is unsure whether your process meets DEA standards, review your inventory framework carefully. Inventory errors are one of the most preventable DEA findings — yet they remain common.
2. Accountability Audit Variances
During inspections, DEA frequently pulls 8–10 controlled substances for a full accountability audit:
Beginning Inventory
- Receipts
– Distributions to End Patient
– Returns/Destruction
= Ending Inventory
Expected variance: Zero.
ADC systems track internal movement. DEA requires reconciliation to the patient level.
The HHS Office of Inspector General has repeatedly highlighted weaknesses in controlled substance oversight, reinforcing why DEA accountability scrutiny has intensified.
If your team has never run a DEA-standard zero-variance audit under inspection conditions, that is a significant readiness gap.
Accountability Audits Shouldn’t Be First Run During an Inspection
If your pharmacists are learning DEA computation charts while inspectors are onsite, it’s too late.
Proactive testing prevents reactive remediation.
3. Power of Attorney & Registration Gaps
DEA inspections frequently uncover technical documentation gaps such as:
- Incorrect Power of Attorney signatures
- Outdated POA forms
- CSOS certificate mismatches
- Improper registration for off-site locations
Each physical address handling controlled substances must maintain proper DEA registration.
These may seem administrative — but they are enforceable compliance requirements.
What the DEA Actually Evaluates During an Inspection
DEA inspections typically evaluate:
- Physical security controls
- Controlled substance storage
- Recordkeeping systems
- Theft and loss reporting (DEA Form 106)
- Employee training documentation
- Diversion detection systems
The regulatory expectation is maintaining “effective controls to guard against diversion.”
The regulations do not provide a checklist defining what “effective” means. That determination often occurs during the inspection itself.
Which means how you operationalize your diversion program matters.
Diversion Programs: Detection Speed Determines Risk
DEA understands diversion cannot be prevented 100%.
However, enforcement severity often hinges on:
- How quickly diversion was detected
- Whether leadership oversight was active
- Whether employees were trained
- Whether policies were consistently enforced
Facilities that detect diversion in weeks are treated differently than those where diversion goes undetected for months.
Strong programs typically include:
- Monthly leadership diversion meetings
- Electronic diversion surveillance tools
- Manual audit spot checks
- Waste verification monitoring
- Executive oversight review
Leadership Accountability Matters
DEA increasingly evaluates executive oversight — not just pharmacy documentation.
If your diversion program has not been stress-tested at the leadership level, now is the time.
👉 Request an Executive Diversion Compliance Review
We help healthcare leaders reduce regulatory exposure before enforcement escalates.
Employee Interviews: A Hidden Risk
During investigations, DEA interviews staff to assess:
- Reporting awareness
- Policy knowledge
- Training documentation
- Diversion escalation procedures
Statements like:
“I wasn’t trained on that.”
“I didn’t know I was supposed to report it.”
can shift findings from individual misconduct to institutional failure.
Preparing for a DEA inspection includes reviewing your training documentation and ensuring staff can confidently articulate your diversion policies.
How to Prepare for a DEA Inspection the Right Way
The most effective way to prepare for a DEA inspection is to simulate one before it happens.
That includes:
- Conducting mock inspections
- Running accountability audits in advance
- Building a DEA inspection binder
- Reviewing registration accuracy
- Auditing biennial inventory execution
- Validating diversion detection systems
Most facilities experience their first real compliance wake-up call during a mock inspection — not during an actual DEA visit.
Waiting until inspectors arrive is not a strategy.
Ready to Prepare Before the DEA Arrives?
DEA inspection readiness isn’t theoretical.
It’s operational.
RXPERT Solutions provides:
- DEA Mock Inspections
- Accountability Audit Testing
- Diversion Program Assessments
- DEA Inspection Binder Development
- Post-Investigation Remediation
👉 Schedule Your Free 30-Minute DEA Risk Assessment Today
Because when the DEA walks through your doors, preparation determines the outcome.
