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Disposal Q&A
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Disposal Q&A
Disposal
Question: What should DEA-registered practitioners do when they discover
controlled substance prescription medications (schedules II-V) that have
been abandoned by patients and/or visitors at the practitioner's registered
locations?
Answer: This question applies in the context where controlled substance
prescription medications (schedules II-V) are considered "abandoned" as
patients and/or visitors no longer possess the controlled substance because
they left the controlled substance at a practitioner's registered location
and they cannot be returned. In order to avoid such an "abandonment",
practitioners may try to contact the patient or visitor who had left such
medications at the practitioner's location in order for the patient or
visitor to obtain the controlled substance medication and maintain
possession. If practitioners successfully contact the patient or visitor,
then they may return such medications to the proper owner in person upon
verification that the owner is the ultimate user of the medication. The
Controlled Substances Act defines "ultimate user" as "a person who has
lawfully obtained, and who possesses, a controlled substance for his own
use or for the use of a member of his household or for an animal owned by
him or by a member of his household." 21 U.S.C. 802(27). However, the
remainder of this response addresses circumstances where such a return is
not feasible and the controlled substance is considered abandoned.
As DEA explained in the preamble of the Final Rule titled "Disposal of
Controlled Substances" (79 FR 53519, September 9, 2014), the DEA has
limited authority regarding who may deliver pharmaceutical controlled
substances for the purpose of disposal. Pursuant to the Secure and
Responsible Drug Disposal Act of 2010, Congress granted DEA authority to
authorize three groups of people to deliver controlled substances for the
purpose of disposal.
First, an ultimate user who has lawfully obtained a pharmaceutical
controlled substance may deliver the substance to another person who is
authorized to accept it for the purpose of disposal.
Second, if a person dies while lawfully in possession of a
pharmaceutical controlled substance, any person lawfully entitled to
dispose of the decedent's property may deliver the substance to another
person for the purpose of disposal. 21 CFR 1317.30.
Third, long term care facilities may dispose of pharmaceutical
controlled substances on behalf of ultimate users who reside or have
resided at such facilities. 21 U.S.C. 822(g).
The DEA has no authority to expand the types of individuals and entities
lawfully permitted to deliver pharmaceutical controlled substances for the
purpose of disposal.
As such, DEA regulations do not permit practitioners to dispose of
abandoned controlled substances, even if the ultimate user is a patient of
the practitioner. Federal, state, and tribal laws may also prohibit such
disposal. Therefore, when controlled substance prescription medications
(schedules II-V) are abandoned by patients or visitors and return to them
as the ultimate user is not feasible, DEA recommends that practitioners
contact state, local, and tribal law enforcement or their local DEA office
as soon as possible for guidance on proper disposal procedures. 79 FR
53546.
DEA notes that some hospitals/clinics, Narcotic Treatment Programs (NTPs),
and other institutional practitioners operate in states that have passed
laws or regulations authorizing the disposal of controlled substances that
have been dispensed to an admitted patient and are considered abandoned
(e.g., the patient left the controlled substance medications and they
cannot be returned; or the patient is deceased and the state has authorized
that the hospital can dispose of the decedent's personal property to
include controlled substance medications). The hospitals/clinics, NTPs, and
other institutional practitioners located in these states should dispose of
the abandoned controlled substance medications in accordance with federal,
state, local, and tribal laws and regulations pertaining to disposal of
controlled substances. DEA defines "institutional practitioner" to mean a
hospital or other person (other than an individual) licensed, registered,
or otherwise permitted by the United States or the jurisdiction in which it
practices, to dispense a controlled substance in the course of professional
practice, but does not include a pharmacy. 21 CFR 1300.01.
Before handling any abandoned controlled substances, DEA registrants are
advised to take every precaution to ensure the safety of their staff,
patients, and visitors. Illicit counterfeit medications containing
fentanyl, methamphetamine, or other potentially lethal substances, often
look like legitimate prescription drugs. Because registrants cannot be sure
of the contents of any abandoned medications, extreme care should be taken
when handling them. When in doubt, registrants should contact local law
enforcement or their local DEA office. EO-DEA238, DEA-DC-073, June 13, 2023
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 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. EO-DEA122A,
DEA-DC-058, September 15, 2022
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. EO-DEA122B,
DEA-DC-059, September 15, 2022
Question: Who is responsible for filing a DEA Form 106 if a sealed inner
liner is stolen, lost, or missing from Federal, State, tribal, or local law
enforcement agencies before the sealed inner liner is picked up for
destruction or destroyed on-site?
Answer: Federal, State, tribal, or local law enforcement agencies may
collect and dispose of controlled substances from ultimate users and other
non-registrants as permitted by 21 CFR 1317.30 and 1317.35. Additionally,
Federal, State, tribal, and local law enforcement agencies utilizing
collection receptacles are exempt from the registration and reporting
requirements otherwise imposed on DEA registrants. See 21 CFR
1301.24(a)-(b). Because the law enforcement agencies in this scenario are
not registrants, they therefore would not be obligated to report thefts or
significant losses of controlled substances to DEA, or file a DEA Form 106.
See 21 CFR 1301.24(a)-(b); 21 CFR 1301.74(c); 21 CFR 1301.76(b). Such a law
enforcement agency may nevertheless contact the DEA field office in its
area if the law enforcement agency desires assistance with conducting its
investigation if a theft or significant loss of a sealed inner liner
occurs. EO-DEA122C, DEA-DC-060, September 15, 2022
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). EO-DEA122D, DEA-DC-061, September 15, 2022
Question: When is a DEA-registered reverse distributor considered to have
received a sealed inner liner either from a DEA registrant authorized as a
collector or a Federal, State, tribal, or local law enforcement agency (law
enforcement)?
Answer: In accordance with 21 CFR 1317.15, 21 CFR 1317.55, and 21 CFR
1304.21(d), a reverse distributor acquires controlled substances (including
sealed inner liners) when it picks up the controlled substances from a
registrant at the registrant's registered location or authorized
collection site or from law enforcement, or when it receives the controlled
substances delivered by common or contract carrier or delivered directly by
a non-practitioner registrant or law enforcement.
Additionally, 21 CFR 1317.15(d) states, "A reverse distributor shall
destroy or cause the destruction of any controlled substance received for
the purpose of destruction no later than 30 calendar days after receipt."
See 21 CFR 1317.05(c)(2)(iv)-(v) regarding authorized methods of sealed
inner liner destruction. DEA reverse distributors are also reminded of
their record keeping obligations with respect to sealed inner liners. See
21 CFR 1304.22(e)(4)-(5). EO-DEA122E, DEA-DC-062, September 15, 2022
Question: Do controlled substances that are broken, spilled, and/or damaged
need to be reported to the Drug Enforcement Administration (DEA)?
Answer: While neither the Controlled Substances Act nor DEA's regulations
specifically address reporting the breakage and/or spillage of a controlled
substance, on August 12, 2005, DEA published in the Federal Register (FR) a
Final Rule, Reports by Registrants of Theft or Significant Loss of
Controlled Substances, 70 FR 47094. In that rule, DEA remarked that
previous guidance on the topic, given in a July 8, 2003 Notice of Proposed
Rulemaking and Guidance Document, Reports by Registrants of Theft or
Significant Loss of Controlled Substances, 68 FR 40576, was adequate and
sufficiently clear: the witnessed breakage or spillage of a controlled
substance does not constitute a loss of controlled substances because the
registrant can account for the controlled substances; these types of
incidents do not require notification to DEA. 70 FR 47096; see also 68 FR
40578. DEA also stated that registrants "should continue to employ common
sense, good faith approaches to their reporting and recordkeeping
obligations in the case of breakage and spillage." 70 FR 47096. DEA
registrants are also reminded of their recordkeeping obligations with
respect to controlled substances that are disposed of by destruction. See
21 CFR 1304.22(a)(2)(ix). EO-DEA144. DEA-DC-051, June 17, 2021
Question: How are controlled substances in a registrant's inventory to be
handled when a registrant dies?
Answer: When a registrant dies, the DEA registration terminates and the
inventory of controlled substances must be disposed of. Per 21 CFR
1301.52(a), a DEA registration terminates when a person dies, as well as
when the business ceases legal existence, a business or professional
practice is discontinued, or a registrant surrenders their registration.
DEA regulations do not permit controlled substances in a registrant's
inventory to be disposed of by way of drug take-back collection. See 21 CFR
1317.05, 1317.65. For individuals or entities handling a deceased
registrant's affairs, local or State law enforcement should be contacted to
assist in picking up controlled substances inventory for disposal. For
uncommon situations, such as those involving the location of controlled
substance inventories subsequent to a registrant death, local DEA Diversion
offices can be contacted and consulted for guidance on next-steps.
EO-DEA224, October 5, 2020
Question (Chemical Digester Disposal): Some pharmaceutical disposal
products on the market, like a chemical digester, say they meet DEA's
"non-retrievable" standard. May I use it to destroy my controlled substance
inventory?
Answer: To comply with the DEA regulations when disposing of a controlled
substance, registrants must use a method which renders the substance
"non-retrievable" (21 CFR 1317.90(a)) and otherwise complies with relevant
law and regulations. The term "non-retrievable" is defined in a results
oriented manner as DEA requires the substance to be permanently rendered to
an unusable state. 21 CFR 1300.05. The performance standard is that the
method irreversibly renders the substance such that it cannot be
transformed to a physical or chemical condition or state as a controlled
substance or controlled substance analogue. Thus, regardless of whether the
product claims to render controlled substances non-retrievable, to comply
with the DEA regulations, a registrant that disposes of a controlled
substance must use a product or method that actually does render the
controlled substance non-retrievable within the meaning of the DEA
regulations. Much like DEA does not evaluate, review, or approve the
specific processes or methods utilized to produce, synthesize or propagate
a controlled substance, DEA will not evaluate, review, or approve the
processes or methods utilized to render a controlled substance
"non-retrievable," as long as the desired result is achieved. EO-DEA178,
October 5, 2020
Question: May a Long-Term Care Facility (LTCF) dispose of controlled
substances on behalf of an LTCF resident or decedent?
Answer: Yes. An LTCF may dispose of controlled substances in schedules II-V
on behalf of a resident or decedent of the facility who is or was in lawful
possession of that controlled substance. 21 CFR 1317.30(b)(3). The
controlled substances must be disposed of by transferring them into an
authorized collection receptacle located at that LTCF within three business
days after the permanent discontinuation of use as directed by the
prescriber, or the resident's transfer from that facility, or as a result
of death. 21 CFR 1317.80. An LTCF must also ensure disposal is done in
accordance with all applicable State, tribal and local controlled substance
disposal laws and regulations. EO-DEA174, October 5, 2020
Destruction
Question: What alternatives to incineration do I have to destroy controlled
substances in my inventory?
Answer: A registrant can transfer expired or unwanted controlled substances
to a reverse distributor for final destruction; the reverse distributor
will typically use incineration or a method that renders the controlled
substance non-retrievable. A registrant also has the option of destroying
controlled substances on-site at their registered location provided the
destruction method meets the non-retrievable standard. Registrants who
destroy their controlled substance inventory must document the destruction
on a DEA Form 41 (see 21 CFR 1304.21(e). EO-DEA200, October 5, 2020
Question: I am a pharmacist and my pharmacy has some outdated controlled
substances that need to be destroyed. Is there another method I can use,
other than incineration, to dispose of these controlled substances?
Answer: Not at this time. The controlled substances you are referring to
are part of your inventory. The regulations enforced by DEA require that
controlled substances, which are part of a DEA registrant's inventory, be
disposed of to the point of being non-retrievable. 21 CFR 1317.90(a).
EO-DEA221, 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.
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DIVERSION CONTROL DIVISION
U.S. Department of Justice
Drug Enforcement Administration
DIVERSION CONTROL DIVISION
8701 Morrissette Drive
Springfield, VA 22152
1.800.882.9539
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