Reporting Theft, Loss, or Missing Sealed Inner Liners from DEA-Registered Authorized Collector Locations

us-doj-guidance-DEA-DC-58Reporting Theft, Loss, or Missing Sealed Inner Liners from DEA-Registered Authorized Collector LocationsGuidance

Drug Enforcement Administration
Diversion Control Division
Guidance Document
Title: Reporting Theft, Loss, or Missing Sealed Inner Liners from DEA-Registered Authorized
Collector Locations
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
from the collector’s registered location (or authorized long-term care facility) before the sealed
inner liner is picked up for destruction or destroyed on-site.
Activity: Filing DEA Form 106 for Stolen, Lost, or Missing Sealed Inner Liners by DEA
Registrants Who are Authorized Collectors
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 a sealed inner liner is stolen, lost, or
missing from a DEA authorized collector’s registered location (or authorized long-term care
facility) before the sealed inner liner is picked up for destruction or destroyed on-site?
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 from an authorized collector’s registered
location (or authorized long-term care facility) before the sealed inner liner is picked up for
destruction or destroyed on-site as allowed by 21 CFR 1317.05(c)(2), the authorized collector
has the responsibility to both report the theft or loss as well as file a DEA Form 106 for the
sealed inner liner. However, the authorized collector does not have 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).
Pursuant to 21 CFR 1317.40, DEA has authorized several types of registrants to be
collectors after modifying their registration in accordance with 21 CFR 1301.51(b). Authorized
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collectors who are DEA registrants are designated as either non-practitioners (i.e.,
manufacturers, distributors, reverse distributors, and narcotic treatment programs), or
practitioners (i.e., hospitals/clinics with an on-site pharmacy and retail pharmacies). 21 CFR
1317.05(c)(2)(iv)-(v). Here, non-practitioner collectors are responsible for filing a DEA Form
106 for the sealed inner liner as directed by 21 CFR 1301.74(c), and practitioner collectors are
responsible for filing a DEA Form 106 for the sealed inner liner as directed by 21 CFR
1301.76(b). 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-DEA122A, DC-DEA-058, September 15, 2022.
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