On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always required registrants to notify their local DEA Field Division Office, in writing, of any theft or significant loss of controlled substances within one (1) business day of the discovery of the theft or loss, but DEA’s regulations have been silent as to when registrants must follow-up on this initial written notice with the subsequent submission of a DEA Form 106. Through the Final Rule, DEA has amended its regulations to now require DEA Forms 106 to be submitted within 45 calendar days after discovery of the theft or loss. Note that DEA’s original proposed rule suggested a 15-day reporting deadline; however, the Final Rule landed on a 45-day deadline after DEA considered the industry’s comments regarding the need for sufficient time to first “complete an accurate and thorough investigation” before submitting a Form 106.

Additionally, while DEA’s regulations have historically been silent as to the method by which DEA Forms 106 are to be submitted (e.g. by mail, by fax, electronically), the Final Rule now requires DEA Forms 106 to be submitted electronically through DEA’s online portal, as has been the requirement for DEA Form 107 reporting requirements for listed chemicals. Given the need for registrants to adjust their practices on how and when to submit DEA Forms 106, the Final Rule will not go into effect until July 24, 2023.

Finally, DEA addressed two other notable issues in the Final Rule that relate to Form 106 reporting. First, in refusing to provide a clear definition of “significant loss,” DEA reminded registrants of its view that whether a loss is “significant” is a determination each registrant must make for itself. On this point, DEA reiterated that repeated losses of small quantities over a period of time may amount to a “significant loss” when considered in the aggregate. Second, DEA acknowledged there is ambiguity with the term “discovery,” which leads to confusion as to when the clock starts for reporting obligations. DEA alerted the industry that, while it is not defining the term in this Final Rule, it plans “on addressing the definition of discovery in future rulemaking.” We will be sure to monitor for this coming clarification and update you accordingly.