Federal Regulations and the Disposal
of Controlled Substances
National Conference Pharmaceutical and Chemical Diversion
Dallas, Texas December 13, 2017
Lynnette Wingert Chief, Policy Unit Drug Enforcement Administration
Legal Disclaimer The following presentation was accompanied by an oral presentation on December 13, 2017, 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.
The Medicine Cabinet and
Pharmaceutical Controlled Substances
Study: Sharing of Medication
1. University of Pennsylvania Dental School Study: More than half of the narcotics prescribed for wisdom teeth removal go unused…findings suggest that more than 100 million pills prescribed go unused…leaving the door open for possible misuse or abuse. Source: https://www.pennmedicine.org/news/news-releases/2016/september/100-million-
prescription-opioid
Study: Sharing of Medication
2. John Hopkins Study: • 60% had leftover opioids they hung
on for “future use” • 20% shared their medications • 8% likely will share with a friend • 14% likely will share with a relative • 10% securely lock their medication https://www.nlm.nih.gov/medlineplus/news/fullstory_159336.html
Secure and Responsible Drug Disposal Act of 2010
P.L. 111-273 October 12, 2010
Federal Register
September 9, 2014
Legislation that provides Ultimate Users and LTCF with additional methods to dispose of unused, unwanted or expired controlled substance medication in a secure, safe and responsible manner.
Secure and Responsible Drug Disposal Act of 2010
• Authorized DEA to promulgate regulations that allow ultimate users to transfer pharmaceutical controlled substances to authorized entities for disposal in a safe and effective manner consistent with effective controls against diversion.
Secure and Responsible Drug Disposal Act of 2010
Regulations do not limit the ways that ultimate users may dispose of pharmaceutical controlled substances—they expand them.
Secure and Responsible Drug Disposal Act of 2010
Participation is voluntary
DEA may not require any person to establish or operate a disposal
program.
Secure and Responsible Drug Disposal Act of 2010
Secure and Responsible Drug Disposal Act of 2010
Ultimate Users may continue to utilize the FDA and EPA guidelines for the disposal of medicines, available at: www.fda.gov www.epa.gov
Ultimate User Ultimate User: “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 a member of his household.” 21 USC § 802(27)
14th National Take Back Day October 28, 2017
DRUG ENFORCEMENT ADMINISTRATION
DIVERSION CONTROL PROGRAM
14th National Take Back Day: October 28, 2017 Total Law Enforcement Participation: 4,274
Drug Enforcement Administration Diversion Control Program
50
60
50 152
145MA 31 RI 53 CT
129 51VT
111 NH
8 PR & VI
148 72
5
268 76
249
29
66
20
15
48
151
195
68
52
193
9
2 HI & Guam
126
177 NJ
44
152
46 52
164
211
53
30
13
136
27
68
78
21
130 63 46 MD
1 DC
22 DE
49
59
*American Indian and Alaskan Native Communities: 64 Partners
14th National Take Back Day: October 28, 2017 Total Collection Sites: 5,321
64
69
68 131
147MA
35 RI
52CT
157
73 VT
114 NH
0 PR & VI
147 69
7
270 91
300
30
91
24
17
52
199
263
86
78
327
17
15 HI & Guam 155
190 NJ
60
171
47 76
240
303
75
71
56
30
18
184
34
85
108
23
167 97 107 MD
7 DC
24 DE
Drug Enforcement Administration Diversion Control Program *American Indian and Alaskan Native Communities: 115 sites
14th National Take Back Day: October 28, 2017 Total Weight Collected (pounds): 912,305 lbs. (456 Tons)
7,687
22,697
9,032 29,700
25,837 MA 3,825
RI
5,814 CT
41,700
5,913VT
13,160 NH
PR & VI
44,081 18,674
389
60,257 26,145
67,273
1,307
19,232
4,467
1,723
16,307
20,364
35,797
11,076
7,932
70,260
4,012
3,215 HI & GU
26,035
14,527NJ
4,800
28,035
3,914 7,019
42,850
36,909
11,668
15,473
10,210
7,452
3,735
37,577
4,620
13,337
11,526
1,780
25,823 5,473
15,069 MD
1,024 DC
5,517 DE
Drug Enforcement Administration Diversion Control Program
Overseas: 56
*American Indian and Alaskan Native Communities: 1507 lbs.
National Take Back I-XIV Totals: Total Weight Collected (pounds): 9,015,668 (4,508 Tons)
107,119
171,309
65,556
183,116
272,773 MA 33,299
RI
85,878 CT
297,540
45,929VT
98,613 NH
16,641 PR & VI
444,560 249,865
4,550
529,277
128,975
669,798
13,461
241,015
29,576
18,009
94,172
173,890
367,350
109,260
60,202
820,250
37,762
33,286 HI & GU
275,082
208,140NJ
49,965
263,654
24,376 60,731
528,761
410,685
132,811
191,415
119,398
56,694
37,204
368,064
79,303
130,996
100,841
19,724
277,363 65,634
122,450 MD 14,327
DC
74,938 DE
Drug Enforcement Administration Diversion Control Program Overseas: 81
14th National Take Back Day American Indian and Alaskan Native Communities Participation October 28, 2017
DRUG ENFORCEMENT ADMINISTRATION
DIVERSION CONTROL PROGRAM
14th National Take Back Day: October 28, 2017 Total American Indian and Alaskan Native Communities Law Enforcement Participation: 64
Drug Enforcement Administration Diversion Control Program
MA 1 RI
CT
VT NH
PR & VI HI & Guam
NJ
1
6
2
MD DC
DE
1 1
2
2
1
1
4 4 4
1
1
2
13
1
5
1
1
4
4 1
14th National Take Back Day: October 28, 2017 Total American Indian and Alaskan Native Communities Collection Sites: 115
Drug Enforcement Administration Diversion Control Program
MA RI
CT
VT NH
PR & VI HI & Guam
NJ
1
9
2
MD DC
DE
1 1
2
2
1
1
4 4 6
2
12
3
20
6
2
1
6
19 1
1
1
2
5
14th National Take Back Day: October 28, 2017 Total American Indian and Alaskan Native Communities Weight Collected (pounds): 1507 lbs. (.754 Tons)
Drug Enforcement Administration Diversion Control Program
MA RI
CT
VT NH
PR & VI HI & Guam
NJ
21
52
10
MD DC
DE
1
40
0
4 0
1
277
128
85
45
10
1
598
21 37
119
26
29
0
0
2
0
Authorized to Collect Following persons are authorized to collect from ultimate user and other non-registrants for destruction:
–Any DEA registrant authorized pursuant to § 1317.40
–Federal, State, tribal, or local law enforcement when in the course of official duties and pursuant to
§ 1317.35 21 CFR § 1317.30
Authorized to Collect DEA Registrants authorized to collect:
–Manufacturers –Distributors –Reverse Distributors –Narcotic Treatment Programs –Hospitals with an on-site pharmacy –Retail Pharmacies
21 CFR § 1317.40
New Authorized Methods of Collection
Lawful collection/possession of controlled substances acquired from ultimate users or other non-registrant persons shall be disposed of in the following ways:
Mail-back Programs Collection Receptacles
Collection Receptacles
Design of Collection Receptacle
Collection Receptacle Location Must be securely placed and maintained:
• Inside collector’s registered location • Inside law enforcement’s physical
location, or • Inside an authorized LTCF
Design of Collection Receptacle • Securely fastened to a permanent
structure.
• Securely locked, substantially constructed container with permanent outer container and removable inner liner.
• Outer container must have small opening that allows for contents to be added, but does not allow for removal of contents.
21 CFR § 1317.75(e)
Mail-Back Programs
Any authorized collector that has and utilizes at its registered location (on-site) a method of destruction consistent with § 1317.90
21 CFR § 1317.70
Mail-Back Program – Who is
Authorized to Operate?
Mail-Back Program
Requirements of mail-back program –Only lawfully-possessed
Schedules II-V controlled substances may be collected
–Controlled and non-controlled substances may be collected and comingled
21 CFR § 1317.70 (b)
Mail-Back Packaging Packages may be made available for sale or free of charge
Any person may partner with a collector or law enforcement to make packages available 21 CFR § 1317.70 (c)
Mail-Back Package Specifications
Packages may only be mailed from the customs territory of the United States:
• 50 States • District of Columbia • Puerto Rico
21 CFR § 1317.70 Personally identifiable information shall not be required when using mail-back package.
Disposal 21 CFR Part 1317
Inventory vs
Waste
Disposal of
Inventory By
Practitioners
Disposal for Practitioners
21 CFR § 1317.05 (a) Practitioner inventory. Any registered practitioner in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways:
Disposal for Practitioners
(1) Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction;
Disposal for Practitioners
(2) Promptly deliver that controlled substance to a Reverse Distributor (registered location) by common or contract carrier pick-up or by reverse distributor pick-up at the registrant's registered location
Disposal for Practitioners (3) For the purpose of return or recall, promptly deliver that controlled substance … to … (T)he registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf
Disposal for Practitioners
(4) Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located.
Non-retrievable … a process that permanently alters the substance’s physical or chemical condition or state through irreversible means, and thereby renders the controlled substance unavailable and unusable for all practical purposes. 21 CFR § 1300.05(b)
Destruction of Controlled Substances
Destruction of Controlled Substances
All controlled substances destroyed by a registrant, or caused to be destroyed by a registrant, shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable.
21 CFR § 1317.90
Disposal of
Waste By
Practitioners
Destruction of Controlled Substances
All controlled substances destroyed by a registrant, or caused to be destroyed by a registrant, shall be destroyed in compliance with applicable Federal, State, tribal, and local laws. See “Dear Practitioner” Letter, Destruction of Pharmaceutical Waste October 17, 2014.
Records: Destruction of Inventory
21 CFR § 1304.21 (e) • DEA Form 41 • Complete and Accurate Record • Name and Signature of the Two
Employees who Witnessed the Destruction
Records: Destruction of Waste
21 CFR § 1304.21 (e) No DEA Form 41 21 CFR § 1304.22(a)(2)(ix) Date, Quantity, and Manner of Disposal
Drug Recall or
Investigational Drug Return
Drug Recall: Ultimate User Return
If controlled substances are recalled, ultimate users may deliver the recalled substance to the manufacturer, or another registrant authorized to accept recalled substances on the manufacturer’s behalf. 21 CFR § 1317.85(a) & (b)
Termination of Ability to Collect Registrant shall notify the DEA in writing or online. 21 CFR § 1301.52(f) 21 CFR § 1317.70 (e)(3)
https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1 (Disposal location search tool, for disposal of medications) www.rxdrugdropbox.org (Police Department Locations, for disposal of medications) www.disposemymeds.org (Pharmacy Locations, for disposal of medications) www.fda.gov (Search: Disposal) https://www.epa.gov/sites/production/files/2015-06/documents/how-to-dispose-medicines.pdf
Patient Resources for Disposal (Anytime of the Year)
Contact Information
Phone: 202-307-7297 E-mail: [email protected]
DEA Diversion Control Division Attn: Liaison and Policy Section 8701 Morrissette Drive Springfield, VA 22152
DIVERSION OF THE DISPOSED • PRACTITIONERS üUsing unapproved
destruction devices ü Take drugs from patients
• REVERSE DISTRIBUTORS ü Failure to have two
employees handle the drugs including transportation and destruction
DIVERSION OF THE DISPOSED • PHARMACY ü Take drugs from patients
üDo not complete records
accurately with reverse distributors
• Others ü Stealing from Sharps
Containers
ü LTC Facilities stealing
deceases patient’s drugs ü LTC Facilities – own
pharmacy (use left over meds)
Officer Accused Of Stealing Painkillers From Evidence Room, Drug Drop Box Aberdeen, Maryland
Meeker County deputy is accused of stealing drugs from a drop box and toys from a holiday toy drive Litchfield, Minnesota
Vineland officer charged with taking meds from prescription drop box Bridgeton, New Jersey
EQUAL OPPORTUNITY DESTROYER
Questions / Thank You
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