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URL:https://www.deadiversion.usdoj.gov/...9/july_2019/arnold.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 James "Jim" Arnold, Chief Liaison Section

The following presentation was accompanied by an oral presentation on July 22 & 23, 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

Practition ers, 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