Section 6.4: Controlled Substance Theft or Loss Reporting

Section 6.4: Controlled Substance Theft or Loss Reporting

Introduction: The Stakes of Controlled Substance Security

The diversion of controlled substances is a significant public health threat, and pharmacies are on the front lines of preventing these drugs from entering illicit channels. Because of the high potential for abuse and harm, both federal and state laws impose strict security and reporting requirements when controlled substances are stolen or lost. Failing to timely report a theft or significant loss is a major violation of both DEA regulations and Texas State Board of Pharmacy (TSBP) rules, and it can result in severe administrative penalties, fines, and the suspension or revocation of the pharmacy's license and DEA registration. Pharmacists-in-charge (PICs) and staff pharmacists must understand the specific timelines, forms, and jurisdictional authorities involved in theft and loss reporting.

Federal DEA Reporting Requirements: The One Business Day Rule

Under federal regulations (21 CFR § 1301.76(b)), a DEA registrant must notify the DEA Field Division Office in writing of any theft or significant loss of controlled substances.

• The Timeline: The initial notification must occur within one business day of discovery of the theft or significant loss.
• The Format: The notification should be sent in writing (via fax, email, or physical mail) directly to the local DEA Diversion Field Office. This initial message does not need to be the complete DEA Form 106, but it must inform the DEA that a theft or significant loss has occurred, providing the pharmacy name, DEA number, address, date of discovery, and a brief description of the circumstances.
• DEA Form 106 Submission: After sending the initial one-business-day notification, the registrant must conduct a thorough investigation to determine the exact quantities and substances lost. The DEA allows the registrant up to 45 calendar days from the date of discovery to complete and submit the electronic DEA Form 106 through the DEA's secure online portal. If the pharmacy cannot complete its investigation within 45 days, it must request an extension from the DEA in writing, explaining the reasons for the delay.

Defining "Significant Loss": The DEA Factors

Federal law does not provide a specific numerical threshold to define what constitutes a "significant" loss. Instead, the responsibility falls on the registrant to exercise professional judgment. The DEA provides six factors that a registrant must consider when determining whether a loss is significant:

1. The actual quantity of controlled substances lost: A loss of 500 tablets is more likely to be significant than a loss of 5 tablets.
2. The specific controlled substances lost: The loss of a Schedule II opioid like fentanyl or oxycodone is far more significant than the loss of a Schedule V anti-diarrheal like diphenoxylate/atropine.
3. Whether the loss can be associated with access to those substances by specific individuals: If the loss is linked to a specific employee or a pattern of scheduling, it is highly significant and points to internal diversion.
4. A pattern of losses over a period of time: Repeated small losses that occur over weeks or months are considered significant when viewed cumulatively.
5. Whether the specific substances are candidates for diversion: Drugs with high street value (e.g., alprazolam, promethazine/codeine, hydrocodone) are prime targets for diversion.
6. Local trends and other indicators of the diversion potential of the substance: If a specific drug is currently experiencing a surge in local abuse, a loss of that drug carries greater significance.

• Best Practice: When in doubt, the DEA recommends that the registrant err on the side of caution and report the loss.

Texas State Board of Pharmacy (TSBP) Immediate Reporting Rule

While federal law allows one business day for the initial DEA notification, Texas state law is more stringent. Under TSBP Rule 291.34, the theft or significant loss of any controlled substance must be reported to the Board immediately upon discovery.

• Satisfying the Requirement: The pharmacy must submit documentation to TSBP as soon as the loss is discovered. The pharmacy can satisfy this state-level requirement by submitting:
  1. A copy of the completed DEA Form 106 (if the exact details are known immediately); OR
  2. A detailed list of all controlled substances stolen or lost, along with a description of the circumstances.
• If the exact quantities are not immediately known, the pharmacy should notify TSBP of the incident immediately and follow up with the completed DEA Form 106 copy as soon as the electronic form is submitted to the DEA (within the 45-day window).

Theft or Loss of Non-Controlled "Dangerous Drugs" in Texas

A unique and highly testable aspect of Texas pharmacy law is that theft and loss reporting is not limited to controlled substances.

• Dangerous Drugs: Under TSBP rules, a pharmacy must also report any theft or significant loss of dangerous drugs (non-controlled legend prescription drugs).
• The Procedure: Immediately upon discovering the theft or significant loss of a dangerous drug, the pharmacist-in-charge must submit a written report to the TSBP. Because dangerous drugs do not fall under DEA jurisdiction, the pharmacy does not submit a DEA Form 106. Instead, they must send a letter or written notification to the Board containing:
  • The pharmacy's name, address, and TSBP license number.
  • A detailed list of the dangerous drugs and quantities lost.
  • The date of the loss and the circumstances surrounding the incident.

Special Situations: In-Transit Losses and Delivery Discrepancies

When controlled substances are lost or stolen before they reach the pharmacy, the party responsible for reporting depends on who has legal custody at the time of the loss:

• In-Transit Loss (Supplier Responsibility): If the shipment is stolen or lost before the pharmacy signs for and takes physical possession of the delivery, the distributor/supplier is responsible for reporting the loss to the DEA. The distributor must submit the DEA Form 106.
• Pharmacy Responsibility: Once the pharmacist signs the delivery invoice and takes custody of the shipment, the pharmacy is legally responsible. If a discrepancy is discovered after the delivery is accepted, the pharmacy must report the loss to the DEA and TSBP.
• Rule of Thumb: If you sign for the box, it is your responsibility. If you notice a shortage before signing, refuse the delivery or have the driver document the discrepancy, and let the supplier handle the report.

Breakage, Spillage, and Waste: DEA Form 41 vs. DEA Form 106

It is common for tablets to be crushed, liquids to be spilled, or injectables to break in a busy pharmacy. Pharmacists must distinguish between a physical loss (where drugs are missing and their whereabouts are unknown) and breakage/spillage (where the drugs are damaged but accounted for).

• Breakage or Spillage (Disposal): When controlled substances are broken, spilled, or otherwise damaged but the physical substance is still present, this is not considered a theft or loss. The damaged drugs must be disposed of through a registered reverse distributor or an approved destruction process. This is documented using DEA Form 41 (Registrant Record of Controlled Substances Destroyed).
• Unrecoverable Spillage: If a liquid controlled substance is spilled down a sink or onto the floor and cannot be recovered, the pharmacist should document the incident in the pharmacy's logbook with two witness signatures. Since there is no drug remaining to destroy, a DEA Form 41 is not submitted, and since the drug was not stolen or lost, a DEA Form 106 is also not submitted. It is simply recorded as a loss in the pharmacy's internal inventory records.