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compliance

DEA Form 106 Controlled Substance Loss Reporting

DEA Form 106 Controlled Substance Loss Reporting captures theft, significant loss, or diversion details, the preliminary notice, and the DEA Form 106 filing trail in one place. Use it to document what happened, when it was discovered, and what was reported next.

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Overview

DEA Form 106 Controlled Substance Loss Reporting is the incident record you use to capture a theft, significant loss, or diversion event from first discovery through final submission. It organizes the submission basis, discovery date and time, registrant and facility details, substance information, incident narrative, law enforcement status, preliminary notice, DEA Form 106 filing, and corrective actions in one place.

Use this template when you need a clear internal trail for a controlled substance incident and want to avoid missing key reporting fields. It is especially useful for pharmacies, hospitals, clinics, and other registrants that must document what happened, what was reported, and who reviewed the case. The structure supports accurate field entry, conditional follow-up, and a clean audit trail for later review.

Do not use it for routine inventory counts, non-controlled medication discrepancies, or general workplace incidents that do not involve controlled substances. It is also not the right fit if you are collecting broad investigative notes with no reporting obligation. Keep the record focused on the minimum necessary facts, and avoid speculative language in the incident description. If you need patient-level or employee-level details, add them only when they are required for the case and permitted by policy.

Standards & compliance context

  • This template supports an audit trail for controlled substance loss reporting by separating discovery, preliminary notice, and DEA Form 106 submission dates.
  • Use minimum-necessary data collection when adding incident details, and avoid collecting unrelated PII unless it is required for the report or internal review.
  • If employee or patient information is added, include consent or disclosure language where required by policy and keep access limited to authorized reviewers.
  • For public-facing intake or shared workflows, make required versus optional fields explicit and ensure the form remains usable and accessible under WCAG 2.1 AA principles.

General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.

What's inside this template

Submission Notice

This section establishes the incident type and the discovery timeline so the reporting clock is visible from the start.

  • Report Type (required)
  • Why are you submitting this report? (required)

    Briefly describe the reason for reporting and the circumstances that triggered discovery.

  • Date of Discovery (required)

    Use the date the theft, loss, or diversion was first discovered.

  • Time of Discovery
  • I understand the preliminary notice must be sent to the local DEA Field Division within one business day of discovery and DEA Form 106 must be filed electronically within 45 days, per 21 CFR 1301.76(b). (required)

Registrant and Location Information

This section ties the event to the correct DEA registrant and facility, which is essential for accurate filing.

  • DEA Registrant Name (required)
  • DEA Registration Number (required)

    Enter the DEA registration number associated with the affected location.

  • Facility Name (required)
  • Facility Address (required)

    Provide the physical location where the loss occurred or was discovered.

  • Facility Type (required)

Controlled Substance Details

This section identifies exactly what was lost so the report can be matched to inventory and schedule records.

  • Controlled Substance Name (required)
  • DEA Schedule (required)
  • Dosage Form

    Examples: tablet, capsule, vial, patch, solution.

  • Strength / Concentration

    Examples: 10 mg, 5 mg/mL, 0.1 mg/hr.

  • Package Size

    Examples: 100 tablets per bottle, 10 mL vial.

  • Quantity Lost (required)

    Enter the number of units, bottles, vials, or other count lost.

  • Unit of Measure (required)

Incident Details

This section captures the facts of the event, including where it happened, how it was discovered, and whether law enforcement was involved.

  • Where did the incident occur? (required)
  • Incident Description (required)

    Describe what was discovered, how it was discovered, and any known circumstances.

  • How was the loss identified? (required)
  • Was law enforcement notified? (required)
  • Law Enforcement Agency
  • Police Report Number

Preliminary Notice and DEA Reporting

This section documents the required notice steps and preserves the filing trail for later review.

  • Preliminary notice sent to local DEA Field Division? (required)
  • Preliminary Notice Date
  • Preliminary Notice Method
  • Electronic DEA Form 106 submitted? (required)
  • DEA Form 106 Submission Date
  • Submission Reference Number

Corrective Actions and Review

This section shows what was done immediately, why the incident happened, and who reviewed the final record.

  • Immediate Actions Taken (required)
  • Corrective Action Summary

    Summarize process changes, access controls, or follow-up actions to reduce recurrence.

  • Root Cause Category
  • Reviewed By

    Enter the name or role of the compliance reviewer. Avoid unnecessary PII.

  • Review Date

How to use this template

  1. 1. Start by selecting the report type and recording the discovery date and time, then acknowledge the reporting deadline so the timeline is visible from the beginning.
  2. 2. Enter the registrant and facility details exactly as they appear on the DEA registration so the incident can be tied to the correct location and entity.
  3. 3. Record the controlled substance details using the correct field types for schedule, dosage form, strength, package size, quantity lost, and unit of measure.
  4. 4. Describe the incident factually, including where it occurred, how it was discovered, whether law enforcement was notified, and any police report number if one exists.
  5. 5. Update the preliminary notice and DEA Form 106 fields with the dates, method, and submission reference number, then document immediate actions, root cause, and corrective actions during review.

Best practices

  • Use date pickers and numeric inputs for dates and quantities so users do not enter free-text values that are hard to validate.
  • Keep the incident description factual and time-ordered, and avoid speculation about intent unless it has been confirmed by the investigation.
  • Record the preliminary notice date separately from the DEA Form 106 submission date so the reporting sequence stays clear.
  • Use conditional logic to show law enforcement fields only when notification occurred, which keeps the form shorter and easier to complete.
  • Capture the exact substance name, schedule, strength, and package size from source records instead of relying on memory.
  • Document immediate containment steps before the final corrective action summary so the review shows what was done right away.
  • Limit optional narrative fields to what you will actually use, following data minimization and reducing unnecessary PII collection.

What this template typically catches

Issues teams running this template most often surface in practice:

Discovery date is entered but discovery time is left blank, which weakens the reporting timeline.
The quantity lost is recorded without the unit of measure, making the substance amount ambiguous.
Preliminary notice and DEA Form 106 submission dates are confused or entered in the wrong fields.
Law enforcement notification is marked yes, but the agency name and police report number are missing.
The incident description is too vague to show whether the event was theft, significant loss, or diversion.
Corrective actions are listed as generic training without identifying the root cause category.
The review is closed without a named reviewer or review date, leaving the audit trail incomplete.

Common use cases

Hospital Pharmacy Diversion Review
A hospital pharmacy team uses the template to document a missing controlled substance, capture the discovery timeline, and track whether law enforcement was notified. The review section helps the compliance lead record the root cause and the immediate containment steps taken.
Community Pharmacy Theft Report
A retail pharmacy manager logs a suspected theft from the controlled substance cabinet and records the DEA registration details, substance specifics, and police report number. The template keeps the preliminary notice and DEA Form 106 submission dates in one audit-ready record.
Long-Term Care Medication Discrepancy Escalation
A long-term care facility uses the form when a controlled medication count does not reconcile and the discrepancy appears significant. The structured fields help staff document the incident method, corrective actions, and reviewer sign-off without overcollecting unrelated resident information.
Behavioral Health Clinic Compliance Case Intake
A behavioral health clinic routes a controlled substance loss event through this template before escalation to compliance. Conditional fields keep the workflow focused on the facts needed for reporting while preserving the internal audit trail.

Frequently asked questions

When should this template be used?

Use it when a controlled substance is stolen, significantly lost, or diverted, and you need to document the incident and reporting steps. It is meant for the internal record that supports preliminary notice and DEA Form 106 submission. If the event is only a routine inventory variance with no indication of loss or diversion, this template may be more than you need. Keep the record focused on the facts you can verify.

Who should complete this form?

It is usually completed by the registrant, compliance lead, pharmacy manager, controlled substance officer, or another designated reviewer. The person entering the record should have access to the incident details, inventory records, and any law enforcement information. A second reviewer should confirm the timeline, submission status, and corrective actions before the record is closed. That helps create a cleaner audit trail.

How often is this form filled out?

It is event-driven, not scheduled. Complete a new record for each theft, significant loss, or diversion incident, and update it as more facts become available. If your organization has multiple facilities, each incident should be logged separately so the location and registrant details stay accurate. Do not reuse one record for unrelated events.

What information should be included, and what should be left out?

Include only the fields needed to describe the incident, identify the substance, record the notice timeline, and capture corrective actions. Use precise field types for dates, quantities, and reference numbers, and avoid adding unrelated patient or employee details. Follow data minimization and collect only the PII or incident data you actually need for reporting and review. If a field is optional, keep it optional unless your internal policy requires it.

Does this template replace the official DEA Form 106?

No. This template is a working record that helps you gather and organize the information needed for the official filing. It can support internal review, but it does not replace the required DEA submission process. Keep the submission reference number and dates in the record so you can show what was filed and when. Treat the template as the intake and tracking layer.

What are the most common mistakes when using this form?

Common mistakes include leaving out the discovery time, mixing up the preliminary notice date with the DEA Form 106 submission date, and entering vague descriptions like "missing stock" without the quantity and package details. Another frequent issue is failing to document whether law enforcement was notified and by whom. People also sometimes skip the root cause and corrective action fields, which weakens the review trail. Clear, factual entries make the record more useful.

Can this be customized for different facilities or workflows?

Yes. You can add conditional logic for facility type, incident method, or whether law enforcement was involved, so users only see fields that apply. Many organizations also add approval steps, internal case numbers, or links to inventory logs and camera footage. Keep the form short at first and expand only where your process needs more detail. That reduces completion errors and improves usability.

How does this fit with other systems or records?

This template can sit alongside inventory management, incident reporting, compliance case management, and document storage workflows. You may want to link it to a police report, internal investigation file, or controlled substance inventory record. If your process supports audit trails, keep the submission dates and reviewer names in the same record. That makes later retrieval and review easier.

How should we roll this out across sites?

Start with one facility or one controlled substance program and confirm who owns each field before expanding. Train staff on what counts as significant loss, when preliminary notice is required, and how to avoid speculative entries. Then standardize the review step so every incident is checked for completeness before submission. A short rollout guide usually prevents inconsistent reporting.

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