DEA Form 106 Filing Guide

Statutory Requirement

21 CFR §1301.76(b): "The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such theft or loss."

What Constitutes a Reportable Event

• Theft — any intentional, unauthorized taking of a controlled substance, regardless of quantity or value
• Significant loss — any loss that is not explained by normal inventory variation, including:
• Discrepancies that cannot be resolved after investigation
• Missing controlled substances from inventory or ADC counts
• Controlled substances unaccounted for after patient discharge or transfer
• Unexplained shortages during perpetual inventory
• Diversion by an employee — confirmed or strongly suspected diversion by a staff member with CS access

"Within One Business Day" — What This Means

• The clock starts when you determine a significant loss or theft occurred — not when you first find a discrepancy
• If you discover a discrepancy on Monday and investigate for 3 days, you have 1 business day from the determination (e.g., Thursday)
• BUT — the DEA expects investigation to proceed promptly. Taking 2 weeks to "investigate" before filing will be viewed unfavorably
• "One business day" = the next business day. Friday discovery + weekend = file by Monday
• Federal holidays don't count — discovery on Friday before Labor Day = file by Tuesday

Reportable Thresholds — DEA's Position

Section 1 — Registrant Information

• DEA registration number — verify it's the correct registration for the affected location
• Registrant name — must match exactly what's on the DEA certificate
• Registered address — physical location where the loss/theft occurred
• Business activity code — select the appropriate activity (hospital, pharmacy, etc.)

Section 2 — Contact Information

• Name, title, phone, email of the person filing the report
• Best contact number — someone who can answer follow-up questions
• Alternate contact — important in case the primary is unavailable

Section 3 — Incident Information

• Type of incident: theft, significant loss, or both
• Date of discovery — the date the theft/loss was first determined
• Date of incident (if known) — when the theft/loss actually occurred
• Location of incident — be specific: "Pharmacy ADC, 3rd Floor North Wing" not just "Hospital"
• How the loss/theft was discovered — inventory check, ADC discrepancy, patient complaint, etc.

Section 4 — Drugs Involved

• List each controlled substance with: drug name, strength, dosage form, NDC if available
• Quantity: number of dosage units (tablets, mL, patches, vials)
• DEA schedule (II, III, IV, V) for each drug — verify before submitting
• Total estimated value — use acquisition cost, not retail. If unknown, estimate
• If multiple drugs were involved, list each one separately. Do not aggregate.

Section 5 — Circumstances

• Detailed narrative of the circumstances — who, what, when, where, how
• Include: how the drugs were stored, who had access, any known suspects
• Describe the security measures in place at the time of the incident
• Include any corrective actions already taken
• Be factual — do not speculate or make accusations

Section 6 — Investigation Summary

• Brief summary of steps taken to investigate the loss/theft
• Who conducted the investigation (title, not name if still in progress)
• Any evidence collected (transaction logs, camera footage, witness statements)
• Current status of the investigation