How to Handle a DEA Audit or Inspection

What Inspectors Look For

DEA and state inspectors will review your controlled substance records, security measures, and procedures. Expect them to check your:

• Controlled substance inventory and purchase records
• DEA Form 222s and medication logs
• Invoices and supplier lists
• Storage security (locked refrigerators, locked cabinets, alarm systems)
• Staff credentials and training records

If you stock injectables or compounding materials, inspectors may also photograph supplies, review expiration dates, and verify that medications are labeled and stored correctly.

Know Your Rights During an Inspection

Inspections may be routine or triggered by a complaint. While cooperation is essential, you still have rights.

• Confirm credentials and ask for identification before allowing access.
• Document the inspection. Take note of who was present, what was reviewed, and any statements made.
• Consult counsel if you are uncertain whether to consent to an inspection or if a warrant is required in your state.

Avoid obstructing an authorized inspection, but do ensure that you understand the inspector’s scope and authority.

Prepare Before They Arrive

Your practice should have organized, up-to-date documentation ready for review at any time, including:

• Facility and professional licenses
• Staff DEA registrations
• Controlled substance logs and patient dispensing records
• Policies on security, storage, and disposal
• Records of technology security measures and patient data protection protocols

Ensure all required licenses are visibly posted, staff wear proper identification, and refrigerator logs and temperature records are current. Train staff to remain courteous and cooperative during an investigation. They should clearly understand who the responsible party is and be prepared to promptly direct inspectors to that person or other appropriate personnel. Dispose of expired medications immediately and secure all Schedule II–V drugs under lock and key.

Responding After the Inspection

If deficiencies are found, the DEA or state board will typically issue a report requiring a corrective action plan. Your plan should:

• Address each issue with specific corrective steps
• Assign responsibility and deadlines
• Include updated policies or training documentation

Follow through promptly; inspectors often return to verify compliance.

Annual Self-Inspection Requirements

Many states require the pharmacist-in-charge (PIC) to complete an annual self-inspection using official state forms or worksheets. These self-audits ensure continued compliance and help identify issues before an investigator does.

Stay Compliant Now to Avoid Panic During an Inspection

• Maintain organized, accessible records for at least five years (or as required by state law).
• Conduct internal audits regularly using your state’s inspection checklist.
• Keep a designated compliance officer or pharmacist-in-charge responsible for DEA matters.
• Train staff on inspection protocol and professional conduct during audits.
• Review your physical and electronic security systems annually.