us-doj-guidance-DEA-DC-59•DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s Custody
DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s Custody
us-doj-guidance-DEA-DC-59DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s CustodyGuidance
Drug Enforcement Administration Diversion Control Division Guidance Document Title: DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s Custody Summary: This guidance document addresses whether a Drug Enforcement Administration (DEA) registrant who is an authorized collector has the responsibility to file a Report of Theft or Loss of Controlled Substances (DEA Form 106) if a sealed inner liner is stolen, lost, or missing while in a common or contract carrier’s custody after the DEA authorized collector requests pick-up. Activity: Filing DEA Form 106 for Stolen, Lost, or Missing Sealed Inner Liners by DEA Registrants Who are Authorized Collectors While the Liner is in a Common or Contract Carrier’s Custody To Whom It Applies: DEA registrants authorized as collectors: manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies. Question: Who is responsible for filing a DEA Form 106 if, after a sealed inner liner is picked up from a DEA-authorized collector’s registered location (or authorized long-term care facility) at the DEA-authorized collector’s request, the sealed inner liner is stolen, lost, or missing while in a common or contract carrier’s custody? Answer: All DEA registrants, including DEA-registered authorized collectors, are required to notify the DEA Field Division Office in their 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 registrant must also follow up on the written notification by subsequently filing a DEA Form 106 for the theft or significant loss. 21 CFR 1301.74(c); 21 CFR 1301.76(b). 21 CFR 1301.74(c)(1)-(6) and 1301.76(b)(1)-(6) also direct DEA registrants, including DEA authorized collectors, how they may determine whether a loss is significant. See also the Federal Register (FR) Final Rule published by DEA on September 12, 2005, titled Reports by Registrants of Theft or Significant Loss of Controlled Substances, 70 FR 47094. If a sealed inner liner is stolen, lost, or missing while in a common or contract carrier’s custody after a DEA-registered authorized collector requests pick-up, as allowed by 21 CFR 1317.05(c)(2), the authorized collector from whom the sealed inner liner was picked up still has the responsibility to both report the theft or loss as well as file a DEA Form 106 for the sealed inner liner, as all in-transit losses of controlled substances must be reported to DEA, not just significant losses. See 21 CFR 1301.74(c); see also 70 FR 47096. In the alternative, if a reverse distributor arranged for the pick-up of the sealed inner liner from the DEA-registered authorized collector (see 21 CFR 1317.15), using either the reverse distributor’s own employees or via a common or contract carrier hired by the reverse distributor, DEA considers the reverse distributor as having the responsibility to both report the theft or loss as well as file a DEA Form
106 for the sealed inner liner after the liner is picked up. See 21 CFR 1317.15(b), 1301.74(c). On the other hand, neither the authorized collector nor the reverse distributor has the responsibility to file a DEA Form 106 for the actual contents of the liner because an inner liner's contents are not allowed to be sorted or inventoried after being placed in a collection receptacle, and the sealed inner liner may not be opened once it is removed from the collection receptacle. See 21 CFR 1317.60(c); 1317.75(c). In addition, DEA-registered authorized collectors must also be in compliance with applicable State, local or tribal laws. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law, regulations, or Department of Justice policies. EO-DEA122B, DEA-DC-059, September 15, 2022.
Continue your research in ChatGPT or Claude
Connect Omnilex to search the legal corpus from your AI assistant.