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| URL: | https://www.deadiversion.usdoj.gov/...19/nov_2019/guzman.pdf |
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| Title: | Disposal, Return of Patient Meds, and Options for Patients |
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| Body: | Practitioner Diversion
Awareness Conference
Disposal and Returns of Patient Controlled
Substance Medications
Antonio Guzman, Associate Chief
The following presentation was accompanied by an oral presentation
on November 4 & 5, 2019, and does not purport to establish legal
standards that are not contained in statutes, regulations, or other
competent law. Statements contained in this presentation that are not
embodied in the law are not binding on DEA. Summaries of statutory
and regulatory provisions that are summarized in this presentation do
not purport to state the full extent of the statutory and regulatory
requirements of the cited statutes and regulations. I have no financial
relationships to disclose.
LEGAL DISCLAIMER
U.S. Drug Enforcement Administration
Diversion Control Division
This presentation is for educational purposes only. This presentation may not be further copied or used,
with the embedded images and videos, without an independent analysis of the application of the Fair Use
doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use" for purposes such as
criticism, comment, news reporting, teaching, scholarship, education and research.
Fair Use is a use permitted by the copyright statute that might otherwise be infringing. Any potentially
copyrighted material used in this presentation has been reviewed and found to be used in a manner
consistent with Fair Use. A completed Fair Use checklist is attached.
Fair Use Act Disclaimer
U.S. Drug Enforcement Administration
Diversion Control Division
Discuss the Secure and Responsible Drug Disposal Act of
2010, and the implementing regulations of 2014.
Discuss how to properly dispose of practitioner
inventory.
Discuss how to properly dispose of controlled substance
waste.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
Discuss the disposal of controlled substances by the
patient "ultimate user."
Discuss the disposal of patients' controlled substances
at long term care facilities.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
At the completion of this block of instruction you will be able to
answer the following questions:
1. Which method of destruction for controlled substance
practitioner inventory is not allowed?
2. Can a practitioner take back a controlled substance that was
already prescribed or dispensed to a patient?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
3. What is DEA's current recommended method of disposal for
practitioner inventory?
4. When is a DEA Form 41 required for the disposal of controlled
substances.
5. What disposal methods are available for ultimate user's ?
U.S. Drug Enforcement Administration
Diversion Control Division
Practitioners,
36%
Friend or Relative, 54%
Drug Dealer, Stranger, 5%
Other, 5%
Where Do They Come From?
U.S. Drug Enforcement Administration
Office of Diversion Control
Source: Department of Health and Human Services
The Medicine Cabinet
and
Pharmaceutical Controlled Substance Disposal
Authorized the DEA to promulgate regulations that allow
ultimate users to transfer pharmaceutical controlled
substances to authorized entities for disposal.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
A person who has lawfully obtained, and who possesses,
a controlled substance for their own use, or for the use
of a member of their household, or for an animal owned
by them or a member of their household.
21 USC § 802(27)
Ultimate User
U.S. Drug Enforcement Administration
Diversion Control Division
A registered manufacturer, distributor, reverse distributor,
narcotic treatment program, hospital/clinic with an on site
pharmacy, or retail pharmacy that is authorized to so receive a
controlled substance for the purpose of destruction.
The registrant has a modified registration authorizing the
collection of controlled substances from the "ultimate user."
What is a "Collector"
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1300.01(b)
This did not change existing methods of disposal of controlled
substances, for ultimate users but expanded the options.
Ultimate users now have more locations where they can
securely, safely, responsibly, and conveniently dispose of their
unwanted pharmaceutical controlled substances.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
The regulations continue to allow Federal, State, tribal, and local
law enforcement to maintain collection receptacles at the law
enforcement's physical location;
And either independently or in partnership with private entities
or community groups, to voluntarily hold take-back events and
administer mail-back programs.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
Created an exception for LTCFs to transfer pharmaceutical
controlled substances for disposal on behalf of patients who
reside or have resided at that facility.
Secure and Responsible Drug
Disposal Act of 2010
U.S. Drug Enforcement Administration
Diversion Control Division
Benefits to the public are:
Decrease the supply of pharmaceutical controlled substances
available for misuse, abuse, diversion, and accidental ingestion;
and
Protect the environment from potentially harmful contaminants
by providing alternate means of disposal for ultimate users.
Disposal of Controlled
Substances Final Rule of 2014
U.S. Drug Enforcement Administration
Diversion Control Division
A controlled substance is considered "non-retrievable"
when it cannot be transformed to a physical or chemical
condition or state as a controlled substance or controlled
substance analogue...
Non-Retrievable
U.S. Drug Enforcement Administration
Diversion Control Division
21 CFR § 1300.05
The purpose of this destruction standard is to:
Permanently render the controlled substance(s) to a non-
retrievable state and thus prevent diversion of any such
substance to illicit purposes.
Non-Retrievable
U.S. Drug Enforcement Administration
Diversion Control Division
These methods
do not meet the
standard
21 CFR § 1300.05
Disposal of Practitioner
Controlled Substance Inventory
and
Controlled Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
Practitioner options to dispose of inventory are:
Prompt on-site destruction if proper method.
Prompt delivery to a DEA registered reverse distributor by
common carrier or reverse distributor pick-up.
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.05(a) and (b)
Returned or Recalled Controlled Substances
Prompt delivery by common or contract carrier or pick-up at
the registered location by:
Registrant from whom it was obtained.
Registered manufacturer
of the substance.
Another registrant authorized by the manufacturer to
accept returns or recalls on the manufacturers behalf.
21 C.F.R. § 1317.05(a) and (b)
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
A practitioner may also request assistance from
the Special Agent in Charge.
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.05(a) and (b)
DEA is aware that there are companies that claim that their
products can render controlled substance inventories non-
retrievable, and have DEA approval.
DEA has not approved any such products for the disposal of
practitioner inventory.
Products That Advertise
They are Non-Retrievable
U.S. Drug Enforcement Administration
Diversion Control Division
21 CFR § 1300.05
Controlled substance practitioner inventory cannot go
to a collector.
Collectors can only receive controlled substances from
the "ultimate users."
Disposal of Controlled
Substance Inventory
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.05(a) and (b) 21 C.F.R. § 1317.75(c)
DEA allows disposal of controlled
substance waste if:
It is authorized under your states
laws... and
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
It is the remaining portion of used needles, syringes, or other
injectable products in a practitioner environment (hospital,
clinic, physicians office, etc.)
21 C.F.R. § 1304.21(e)
Recordkeeping for disposal of controlled substance waste:
No DEA Form 41 required.
Recommended that two employees witness the handling and
the destruction of the controlled substance waste.
21 C.F.R. § 1317.95(c) and (d)
21 C.F.R. § 1304.21(e)
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
Record of waste disposal must include:
Name of Substance
Form
Quantity
Date of Disposal
Manner of Disposal
21 CFR § 1304.22(c)
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
Records must be maintained at the practitioner's registered
location for a minimum of two years.
Longer if required by state laws or regulations.
21 CFR § 1304.04(a)
Disposal of Controlled
Substance Waste
U.S. Drug Enforcement Administration
Diversion Control Division
A physician cannot take back
controlled substances that have been
administered, prescribed, or dispensed
to the "ultimate user.
U.S. Drug Enforcement Administration
Diversion Control Division
Patient's Controlled
Substances
It is not authorized by Federal Laws and Regulations.
Do not put yourself or your practice in harms way by ignoring
this.
Disposal of Ultimate
User's Controlled
Substances
U.S. Drug Enforcement Administration
Diversion Control Division
DEA recommends that "ultimate users" do not flush their
expired or unwanted prescriptions and over-the-counter
drugs down the toilet or drain unless the label or
accompanying patient information specifically instructs you
to do so.
Be aware the FDA posted instructions to flush certain types
of controlled substances.
"Ultimate User" Destruction
U.S. Drug Enforcement Administration
Diversion Control Division
" Ultimate users" can now return unwanted or expired
prescription and over-the counter drugs to:
Law enforcement supported drug take-back program or
collection box.
DEA registered collector that has an on-site collection
receptacle.
DEA registered mail back program.
"Ultimate User" Destruction
U.S. Drug Enforcement Administration
Diversion Control Division
Collection Receptacles
25
74
700
328
94
296
43
225
8
146
16
DC
12
4
132
120
43
258
82
95
127
118
15
315
161
60
52
129
319
142
37
23
72
100
40
420
278
278
271
95
3
23
97
78
58
415
117
156
37
247
146
67
9
DEA Registrants Only
All Year Collection Sites (99% Pharmacies)
Drug Enforcement Administration, Diversion Control Division As of July 22, 2019
Total: 7,574
Guam 1
LTCFs may dispose of a current or former resident's
unwanted or unused controlled substances in a
collection receptacle located at the LTCF.
Collection at LTCFs
U.S. Drug Enforcement Administration
Diversion Control Division
21 C.F.R. § 1317.80(a)
New Disposal Law Passed
On 10-23-2018 the SUPPORT for Patients and Communities
Act was signed into law
Under certain conditions, an employee of a qualified hospice
program may handle and dispose of, without being registered
by DEA, a controlled substances lawfully dispensed to the
person receiving hospice care, as long as ...
U.S. Drug Enforcement Administration
Diversion Control Division
The controlled substances are destroyed on-site and
In compliance with all Federal, state, and local laws.
New Disposal Law Passed
U.S. Drug Enforcement Administration
Diversion Control Division
Summary of Destruction
Standards
Non-Retrievable
Standard
Not Required to
Comply with
Non-Retrievable
Standard
U.S. Drug Enforcement Administration
Diversion Control Division
Ultimate Users
Practitioner CS Waste Practitioner CS
Inventory
Summary of Disposal
Options
U.S. Drug Enforcement Administration
Diversion Control Division
Practitioner Inventory
DEA Reverse
Distributor
Ultimate User
Collection Box
Mail Back Programs
Commercial Products
Coffee Grounds
Kitty Litter
Etc.
Controlled Substance
Waste
Do not allow patients to bring their previously prescribed or
dispensed controlled substances to your facility prevents
diversion.
Timely proper disposal of inventory prevents diversion.
Timely witnessing and documenting the disposal of controlled
substance waste prevents diversion.
Preventing Diversion
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
1. Which method of destruction of controlled substance
practitioner inventory is not allowed?
a. Return to whomever it was purchased from.
b. Send the controlled substances to a reverse distributor.
c. Return to a DEA registered "collector" or a take back
location.
d. Destroy the controlled substances on-site.
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
2. Can a practitioner take back a controlled
substance that was already prescribed or dispensed
to a patient?
a. Yes
b. No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
3. DEA's recommended way of destruction is by
incineration.
a. True
b. False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
4. Controlled substance waste must always be
reported on a DEA Form 41 (Destruction of
Controlled Substances).
a. True
b. False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
5. A Practitioner can destroy controlled substance
inventory (expired) by placing them into kitty litter
or coffee grinds.
a. True
b. False
U.S. Drug Enforcement Administration
Diversion Control Division
Thank-you for your time
and attention !
U.S. Drug Enforcement Administration
Diversion Control Division
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