federal regulations and the disposal of controlled … regulations and the disposal of controlled...

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: ODLP@usdoj.gov

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