Transportation of Sealed Inner Liners from or by DEA-Registered Authorized Collectors

us-doj-guidance-DEA-DC-61Transportation of Sealed Inner Liners from or by DEA-Registered Authorized CollectorsGuidance

Drug Enforcement Administration
Diversion Control Division
Guidance Document
Title: Transportation of Sealed Inner Liners by DEA-Registered Authorized Collectors or
Common Courier Drivers
Summary: This guidance document addresses whether a sealed inner liner may be transported
by employees of a Drug Enforcement Administration (DEA) registrant authorized as a collector,
or after pick-up by a common courier driver, to a common carrier storefront or franchise prior to
the common carrier transporting the sealed inner liner to a reverse distributor for destruction.
Activity: Transportation of Sealed Inner Liners by DEA Authorized Collectors or Common
Courier Drivers.
To Whom It Applies: DEA registrants authorized as collectors.
Question: Do DEA regulations allow for transportation, whether by employees of a DEA-
registered authorized collector, or after pick-up by a common or contract carrier, of a sealed
inner liner to the common or contract carrier’s storefront or franchise prior to the common or
contract carrier transporting the sealed inner liner to a reverse distributor for destruction?
Answer: DEA’s regulations on disposal do not specifically prohibit these scenarios. 21 CFR
1317.55(c) requires a reverse distributor to acquire collected substances (sealed inner liner) from
DEA registrants authorized as collectors in accordance with 21 CFR 1317.15(b), which directs a
reverse distributor to:
(1) Pick-up controlled substances from a registrant at the registrant's registered location
or authorized collection site; or
(2) Receive controlled substances delivered by common or contract carrier or delivered
directly by a non-practitioner registrant.
(i) Delivery to the reverse distributor by an authorized registrant directly or by
common or contract carrier may only be made to the reverse distributor at the
reverse distributor's registered location. Once en route, such deliveries may not be
re-routed to any other location or person, regardless of registration status.
(ii) All controlled substance deliveries to a reverse distributor shall be personally
received by an employee of the reverse distributor at the registered location.
If a non-practitioner registrant authorized as a collector directly delivers a sealed inner
liner to a reverse distributor as mentioned above, 21 CFR 1317.95(b) requires, in part, that “the
[controlled] substances shall be constantly moving towards their final location and unnecessary
or unrelated stops and stops of an extended duration shall not occur.” 21 CFR 1317.95(b)(1).
Although not mandated by the regulation, DEA suggested in the Federal Register in the Final
Rule, Disposal of Controlled Substances 79 FR 53519, that because transportation to destruction
facilities may occur over long distances, the collected substances (sealed inner liner) should be
constantly moving towards their final destruction destination, and unnecessary or unrelated
stops, and stops of an extended duration should not occur (see 79 FR 53555).
Outside of the above regulatory requirements, and the precatory language set forth in the
Federal Register, DEA does not specify exactly how to transport a sealed inner liner from the
DEA-registered authorized collector to a reverse distributor when utilizing a common courier for
transport. DEA also explained in the above-referenced Final Rule that DEA’s primary concern
regarding common or contract carriers was whether there is adequate security to prevent
diversion when controlled substances are being transported. See 79 FR 53527-53528.
Additionally, all registrants must provide effective controls and procedures to guard against theft
and diversion of controlled substances. See 21 CFR 1301.71(a).
If a DEA-registered authorized collector or reverse distributor has specific questions or
proposals regarding the physical security of the handling of controlled substances, including
transportation plans involving a sealed inner liner, the collector or reverse distributor should
forward and address such questions or proposals to the Special Agent in Charge in the region in
which the proposal pertains, or to DEA’s Regulatory Section. See 21 CFR 1301.71(d).
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-DEA122D, DEA-DC-061, September 15, 2022.

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