Question: What is a Significant Loss or Theft?

Answer: When determining whether a loss is significant, a registrant should consider, among others, the following factors:

  1. The actual quantity of controlled substances lost in relation to the type of business;
  2. The specific controlled substances lost;
  3. Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
  4. A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
  5. Whether the specific controlled substances are likely candidates for diversion;
  6. Local trends and other indicators of the diversion potential of the missing controlled substance 21 CFR 1301.74(c) and 1301.76(b).

The registrant must notify the Local Diversion Field Office of the Administration in his or her area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss. The supplier is responsible for reporting all in-transit losses of controlled substances by their agent or the common or contract carrier selected pursuant to paragraph (e) of this section, within one business day of discovery of such theft or loss. 21 CFR 1301.74(c). The registrant must also complete, and submit to the Local Diversion Field Office in his or her area, DEA Form 106 regarding the theft or loss. Id. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them. Id. EO-DEA188, October 5, 2020

Disclaimer: Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department's guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department's complete discretion, consistent with applicable laws.