Pro-Accounting for DEA Controlled Substances

procedure Accounting for DEA Controlled Substances modified Wed Jun 24 2020 11:13:51 GMT-0400 (Eastern Daylight Time)

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University of Louisville

OFFICIAL
UNIVERSITY
ADMINISTRATIVE
PROCEDURE

PROCEDURE NAME

Accounting for DEA Controlled Substances

EFFECTIVE DATE

PROCEDURE NUMBER

Not applicable

PROCEDURE APPLICABILITY

This procedure applies to University Employees (administrators, faculty, and staff).

PROCEDURE STATEMENT

Damaged, expired, unwanted, unusable, or non-returnable controlled substances must be accounted for, retained, and disposed of in accordance with the following procedure.

A Registrants Inventory of Drugs Surrendered (DEA Form 41) must be completed prior to disposing of any DEA controlled substance. To download a copy of this form, please go view at the following link https://www.deadiversion.usdoj.gov/21cfr_reports/surrend/

Controlled Substance Spills 

Breakage, spills, or other witnessed controlled substance losses do not need to be reported as lost. This type of loss must be documented by the registrant and witness on the inventory record. Controlled substances that can be recovered after a spill, but cannot be used because of contamination (tablets), must be placed in Witness Destruction disposal waste stream (completion of DEA Form 41 required). If the spilled controlled substance is not recoverable (liquids); the registrant must document the circumstances in their inventory records and the witnesses must sign (must include PI as witness in record).

Theft of or Missing Controlled Substances Reporting

The DEA license holder must have complete accountability of all controlled substances stored or used in their area. This makes keeping good records essential so that any shortages or missing controlled substances will not go unnoticed. Theft or misuse of a controlled substance is a criminal act that must be reported to the following agencies: 

Louisville DEA office: 1006 Federal Building, 600 Martin Luther King, Jr. Place, Louisville, KY 40202

Diversion Number: 502-582-5905
Diversion Fax: 502-582-6360 

University Department of Public Safety: 502-852-6111

University DEHS: 502-852-6670

RELATED INFORMATION

To minimize waste, DEA registrants should only purchase quantities they intend to use.  

There are two disposal options for expired or unwanted controlled substances recommended by the University’s Department of Environmental Health and Safety (DEHS).  DEHS should be contacted to help determine the correct disposal method. 

  1. Supplier Disposal: 
    Some suppliers (reverse distribution) will take back pharmaceuticals for credit.  Utilizing this option transfers the ownership of the controlled substances to a DEA registered and authorized processor for destruction or resale. Multiple forms must be completed and the DEA Registration Number is required to utilize this option.  The fee associated with this service will be the responsibility of the registrant.  Contact your vendor to see if this is a viable option. 
  2. Witness Destruction Disposal:
    Small quantities (less than 1 pound) can be disposed by the DEA registrant using the following disposal procedure: 

i.    Contact DEHS, Hazardous Waste Coordinator, Cathy Price, via e-mail at cathy.price@louisville.edu with a DEA controlled substance disposal request. 

ii.    Complete the Registrants Inventory of Drugs Surrendered (DEA Form 41).

iii.    Inform DEHS when the DEA Form 41 has been completed and signed to schedule a date for on-site witness destruction at the Environmental Protection Services Center (EPSC) located at 1800 Arthur Street.  

iv.    DEHS will make arrangements for a University Police Officer and DEHS representative to be present as witnesses to the disposal, and to verify the DEA Form 41 and inventory records. The PI and/or authorized agent must also be present during the destruction.

v.    The controlled substance(s) will be poured into a solvent drum to render the material irrecoverable.  The DEA form 41 will be signed by the university police officer, DEHS representatives, and PI and/or agents to attest that the material has been destroyed.

vi.    DEHS will provide a copy of the DEA Form 41 for the researcher's inventory records. This copy should be retained by the registrant for at least 2 years.   The original DEA Form 41 will be retained in the DEHS office for three years (3) and available for review by a DEA authorized agent request or inspection.

ADMINISTRATIVE AUTHORITY

Senior Associate Vice President for Operations

RESPONSIBLE UNIVERSITY DEPARTMENT/DIVISION

Environmental Health & Safety

University of Louisville

Louisville, KY 40292

502-852-6670

dehsubm@louisville.edu 

HISTORY

Revision Date(s): 

Reviewed Date(s):

The University Policy and Procedure Library is updated regularly. In order to ensure a printed copy of this document is current, please access it online at http://louisville.edu/policies.