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compliance

DEA Form 106 Controlled Substance Loss Reporting

DEA Form 106 Controlled Substance Loss Reporting template for documenting theft, loss, or significant diversion and preparing the details needed for preliminary notice and submission.

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Overview

This template is built for documenting a controlled substance theft, loss, or significant diversion event in a way that supports internal investigation and DEA Form 106 preparation. It captures the incident type, discovery date, reporter details, facility information, inventory impact, preliminary notice status, and certification in a sequence that matches how compliance teams actually work.

Use it when a controlled substance cannot be accounted for, when theft is suspected, or when a diversion event needs to be escalated and documented. The form is especially useful when multiple people are involved, because it separates the person who discovered the issue from the person who certifies the submission. It also creates a clear audit trail for law enforcement notification, corrective actions, and inventory record updates.

Do not use this template for routine inventory reconciliation, general workplace incidents, or non-controlled medications. If the event is still unconfirmed, keep the narrative factual and avoid speculation in the incident summary. The form is also not a substitute for legal review when your organization needs help deciding whether the event is reportable. Keep required and optional fields clearly labeled, use conditional logic for location details and law enforcement follow-up, and collect only the minimum necessary PII needed to complete the report.

Standards & compliance context

  • This template supports controlled substance loss reporting workflows tied to DEA requirements and the preliminary notice process under 21 CFR 1301.76(b).
  • Collect only the minimum necessary PII needed to identify the registrant, reporter, and submitter, consistent with data minimization principles.
  • If the form is used in a healthcare setting, keep the incident narrative limited to the minimum necessary information and avoid unrelated patient details.
  • Use an audit trail for edits, submission timing, and certification so the organization can show who entered and approved the report.

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 event type, discovery timing, and whether the reporter has acknowledged the reporting deadline.

  • Incident type (required)
  • Date and time discovered (required)

    Use the date and time the incident was first discovered. This supports the one-business-day preliminary notice requirement.

  • I understand the reporting timeline requirements (required)

    Preliminary written notice to the local DEA Field Division is due within one business day of discovery, and the electronic DEA Form 106 is due within 45 days per 21 CFR 1301.76(b).

  • Anonymous submission

    Select only if your organization permits anonymous internal intake for initial triage. DEA filing and compliance follow-up may still require registrant identification.

Registrant and Facility Information

This section identifies the registrant, facility, and reporter so the report can be tied to the correct controlled substance registration.

  • DEA registrant name (required)
  • DEA registration number (required)

    Enter the DEA registration number for the affected registrant.

  • Facility name (required)
  • Facility address (required)

    Provide the physical location where the controlled substance was stored, handled, or discovered missing.

  • Reporter name

    Optional internal contact for follow-up. Avoid collecting unnecessary PII.

  • Reporter email

    Optional contact for compliance follow-up.

Incident Details

This section records what happened, where it happened, and whether law enforcement was notified.

  • Date and time of incident (required)
  • Incident location (required)
  • If other, describe the location
  • Incident summary (required)

    Describe what happened, how it was discovered, and any immediate containment actions taken.

  • Was law enforcement notified? (required)
  • Law enforcement details

    Include agency name, report number, and date notified if available.

Controlled Substance Inventory Impact

This section captures the exact product and quantity affected so the loss can be reconciled against inventory records.

  • Controlled substance schedule (required)
  • Product or drug name (required)
  • Dosage form
  • Strength
  • Quantity lost or stolen (required)
  • Unit of measure (required)
  • If other, specify unit of measure
  • Have inventory records been updated? (required)

Preliminary Notice and Investigation

This section tracks the preliminary notice, investigation status, root cause, and corrective actions before final submission.

  • Was written preliminary notice sent to the local DEA Field Division? (required)
  • Date preliminary notice sent
  • Internal investigation status (required)
  • Preliminary root cause or contributing factors

    Use objective findings only. Examples: access control gap, inventory discrepancy, shipping error, documentation error, unexplained shortage.

  • Immediate corrective actions taken

    Describe containment steps, access changes, inventory reconciliation, or security measures implemented.

Certification and Submission

This section confirms who is certifying the report and creates the final submission record.

  • Certification statement (required)

    I certify that the information provided is true and complete to the best of my knowledge and that this report is submitted for compliance review in connection with DEA reporting obligations.

  • Submitter name (required)
  • Submitter title
  • Electronic signature (required)

    Sign to confirm review and authorization to submit the report.

How to use this template

  1. 1. Set up the form with required fields for incident type, discovery date, registrant information, and the controlled substance details needed for reporting.
  2. 2. Assign the form to the person who discovered or is documenting the event, then route it to the authorized reviewer or submitter for validation and certification.
  3. 3. Record the incident facts, including location, summary, law enforcement notification, and inventory impact, using field types that match the data such as date pickers and numeric inputs.
  4. 4. Capture preliminary notice status, investigation progress, root cause, and corrective actions so the case has a complete audit trail before submission.
  5. 5. Review the entry for missing required fields, confirm the reporting deadline acknowledgment, and submit or export the completed record for the official DEA filing workflow.

Best practices

  • Use conditional logic so incident location details only appear when the user selects an 'other' location.
  • Mark PII fields such as reporter name and email as required only when they are needed for follow-up or certification.
  • Enter the controlled substance quantity with a numeric input and a unit of measure field instead of free text.
  • Keep the incident summary factual and time-based, and avoid speculation about motive or responsibility before the investigation is complete.
  • Record whether law enforcement was notified as a separate field so the audit trail is clear.
  • Update inventory records immediately after the discrepancy is confirmed so the form reflects the same count used in the investigation.
  • Use progressive disclosure for root cause and corrective actions so users do not see investigation fields before the event is confirmed.

What this template typically catches

Issues teams running this template most often surface in practice:

The incident type is left vague, which makes it hard to tell whether the event was theft, loss, or diversion.
The quantity lost is entered without the correct unit of measure, creating reporting errors.
Users skip the law enforcement notification field even when police or other authorities were contacted.
Inventory records are not updated after the discrepancy is confirmed, leaving the report and stock records inconsistent.
The incident summary includes speculation instead of verified facts.
The preliminary notice date is missing, making it difficult to show whether the process was started on time.
The submitter signs before the investigation status and corrective actions are documented.

Common use cases

Retail Pharmacy Loss Event
A pharmacy manager documents a missing controlled substance after a shift count and routes the record to compliance for review. The template helps separate the discovery details from the formal certification needed for filing.
Hospital Diversion Review
A health system compliance team uses the form to capture a suspected diversion event, note whether law enforcement was notified, and track corrective actions. The structured fields help keep the investigation focused on facts rather than informal notes.
Distributor Inventory Discrepancy
A wholesaler records a shipment or warehouse discrepancy involving a controlled substance and documents the product, dosage form, strength, and quantity lost. The template supports a clean audit trail for internal review and external reporting.
Clinic Escalation Workflow
A medical clinic uses the form when a controlled substance count does not reconcile and the issue must be escalated to an authorized submitter. The template keeps the intake process consistent across locations.

Frequently asked questions

What is this template used for?

This template captures the facts needed to report theft, loss, or significant diversion of controlled substances and to prepare a DEA Form 106 submission. It organizes the incident, inventory impact, preliminary notice, and certification in one place. That makes it easier to document the event consistently before the formal filing is completed.

Who should complete this form?

It is typically completed by the registrant, compliance lead, pharmacy manager, controlled substance coordinator, or another authorized reporter. The form includes fields for the reporter and submitter so the organization can track who gathered the facts and who certified the report. If your process uses escalation, the person entering the incident can be different from the person signing.

When should this be submitted?

Use it as soon as a theft, loss, or significant diversion is discovered so the reporting deadline is acknowledged early and the preliminary notice can be tracked. The template includes discovery date and preliminary notice fields to support timely action. It is not meant for routine inventory counts or minor discrepancies that do not rise to a reportable event.

Does this template replace the official DEA filing?

No. This template helps collect and structure the information needed for the official process, but it does not replace the required DEA submission. Treat it as a working form for internal intake, investigation, and preparation. The certification field should be completed only by an authorized person who can stand behind the submission.

What compliance issues does it help with?

It supports documentation practices tied to controlled substance loss reporting, including incident details, inventory impact, law enforcement notification, and preliminary notice tracking. It also helps teams maintain an audit trail of what was known, when it was discovered, and what corrective actions were taken. That reduces the chance of incomplete or inconsistent reporting.

What are the most common mistakes when using it?

Common mistakes include leaving the incident location vague, entering the wrong unit of measure, skipping inventory record updates, and failing to record whether law enforcement was notified. Another frequent issue is collecting too much narrative without the specific fields needed for reporting. This template keeps the focus on the facts that matter.

Can we customize it for pharmacies, hospitals, or distributors?

Yes. You can tailor the incident location options, inventory fields, and investigation workflow to fit your operation. For example, a hospital may need more detail on unit-dose packaging, while a distributor may want stronger chain-of-custody notes. Keep the core reporting fields intact so the form still supports the required submission.

How does this fit with internal systems or incident tracking tools?

The form can be used as the intake layer before you move the case into an incident management system, compliance tracker, or document repository. Fields like reporter email, law enforcement details, and inventory records updated make it easier to route the case and preserve an audit trail. If you integrate it, map the controlled substance and incident fields carefully so data stays consistent.

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