Diversion Investigator Ginny McKenna Omaha Field Division, Minneapolis-St. Paul District Office of the Drug Enforcement Administration Diversion Investigator Ginny McKenna

Mission The mission of the Diversion Control Division is to prevent, detect, and investigate the diversion of pharmaceutical controlled substances and listed chemicals from legitimate channels of distribution while … ensuring an adequate and uninterrupted supply of controlled substances to meet legitimate medical, commercial, and scientific needs. The job of the Diversion Investigator is to perform regulatory and other types of complaint investigations to ensure compliance with DEA regulations, determine whether diversion exists, and to ensure that the supply of controlled substances is adequate to ensure the needs of the medical, commercial and scientific communities. U.S. Drug Enforcement Administration Office of Diversion Control

DIVERSION Occurs when legally manufactured controlled substances, or List 1 and List 2 chemicals are diverted from legal uses for use in illegally manufacturing controlled substances (chemicals) or for illegal distribution or consumption (controlled substances). Diversion refers to the exit of controlled substance from the closed system of distribution created by the Controlled Substances Act. This is important to point out because the term can be confusing as it refers to something different than in drug court for example. 21 U.S.C. §§ 821-830

…and other guidance from the Code of Federal Regulations To Sewer or NOT to Sewer …and other guidance from the Code of Federal Regulations

Non-retrievable For the purpose of destruction, non-retrievable is “the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance's chemical or physical properties. 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. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.”¹ ¹ 21 C.F.R. §1300.05(b)

Standard of Destruction Existing DEA regulations didn’t specify a standard The standard is now “non-retrievable” No particular method, just achieve the intended result → prevent diversion MUST meet all other applicable Federal, State, tribal & local laws & regulations Provides leeway for private/public entities to develop various methods Secure Convenient Responsible Consistent to prevent diversion ² ² Federal Register /Vol. 79, No. 174 /Tuesday, September 9, 2014 /Rules and Regulations, page 4 Methods of Destruction; 21 CFR §1300.05, 1317.90, 1317.95, et al. Disposal of Controlled Substances; Final Rule 21 USC §802(27)

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.”³ ³ Federal Register /Vol. 79, No. 174 /Tuesday, September 9, 2014 /Rules and Regulations, 21 CFR Parts 1300, 1301, 1304, et al. Disposal of Controlled Substances; Final Rule 21 USC §802(27)

Long Term Care Facility Ultimate Users Are non-registrants = end of supply chain LTCF may dispose of ultimate user’s controlled substances if s/he resides at or had resided and Left CS behind w/ no intention of return CS was discontinued by practitioner Ultimate user deceased LTCF must transfer to CS to receptacle immediately or w/in 3 days Hospital/clinic w/ pharmacy & retail pharmacies can provide collection receptacles @ LTCF Collector status w/ DEA

Hospice “If person dies while lawfully in possession of a controlled substance, any person lawfully entitled to dispose of decedent's property may deliver the CS to another person for the same purpose of disposal under the same conditions as provided” for ultimate users. 4 Home hospice and homecare workers are NOT authorized to receive pharmaceutical controlled substances unless authorized by state law. 4 Federal Register /Vol. 79, No. 174 /Tuesday, September 9, 2014 /Rules and Regulations; 21 U.S.C. 822(g)(4)

Collection Receptacles Installed by retail pharmacy or hospital/clinic with on-site pharmacy Remove, seal, transfer and store or supervise removal et al at LTCF Installation, removal, transfer & storage of inner liners performed by/under supervision of Employee of authorized collector & supervisor level employee of LTCF or Two employees of authorized collector Upon removal, liner may be stored up to 3 days at LTCF Securely locked, substantially constructed cabinet Securely locked room w/ controlled access until transferred NOTE: DEA can NOT endorse any particular vendor 21 C.F.R. §1317.80

DESTRUCTION!!!! Transfer – Person registered to destroy; authorized to accept controlled substances for destruction 2 employees of transferring registrant shall load/unload or observe loading/unloading until transfer complete Transport – To registered location 2 employees of transporting registrants accompany shipment Direct route w/ no prolonged/unrelated stops 2 transporting employees load/unload or observe until transfer complete Transport – To unregistered location Direct route w/ no prolonged/unrelated stops 2 employees of transporting company accompany shipment Handle or observe handling of CS until rendered non-retrievable On-site destruction – 2 employees handle/observe destruction until non-retrievable 2 employees of registrant shall personally witness until rendered non-retrievable 21 C.F.R. §1317.95

April 2019 NDTB collected 12,676 lbs. of drugs. Have been 16 Take Back events. Totals thus far. April 2019 NDTB collected 12,676 lbs. of drugs.

18th National Drug Take Back Day Saturday October 26, 2019 10 AM to 2 PM Since NDTB began, over 10,878, 950 lbs (5,439 tons) of drugs have been collected from our communities nation-wide.

QUESTIONS??? Ginny McKenna Dick Mah Kimberly Brill Diversion Investigator Tactical Diversion Squad 612-344-4138 100 South Washington Avenue Suite 800 Minneapolis, MN 55401 Dick Mah Special Agent Group Supervisor Tactical Diversion Squad 612-344-4179 dick.l.mah@usdoj.gov 100 South Washington Avenue Suite 800 Minneapolis, MN 55401 Kimberly Brill Diversion Group Supervisor 612-344-4133 kimberly.s.brill@usdoj.gov 100 South Washington Avenue Suite 800 Minneapolis, MN 55401