Disposal of Controlled Substances (DEA Scheduled Drugs)

Policy Number: 3349-R-625
Effective Date: 04/04/2018
Updated: —
Reviewed: —
Responsible Departments: ORSP, Compliance (EOHS)
Approval Authority: VP Research
Responsible Office: CMU, EOHS

A. Purpose

The purpose of this policy is provide appropriate guidance and oversight over the Disposal of Controlled Substances  in accordance and compliance with all local, state and federal regulations.

B. Scope

This policy applies to all personnel on the Northeast Ohio Medical University (NEOMED) Campus and related facilities and operations who are engaged in the use and disposal of controlled substances (Drug Enforcement Administration scheduled Drugs) under the University’s Researcher Drug Enforcement Administration Registration.

C. Definitions

1. Controlled Substances (also known as Scheduled Drugs) refer to drugs that are regulated by the federal Drug Enforcement Administration (DEA) and the Ohio State Board of Pharmacy because of potential for abuse. Schedules can be obtained from 21 CFR 1308 at the site herein. (http://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm)
2. Controlled Substance Program (or the Program) refers to those regulations and procedures that govern the order, use and disposal of Controlled Substances for Research on the NEOMED campus.
3. DEA Research Registration refers to a special DEA license that allows non-practitioner Investigators to obtain and use Controlled Substances in animal research.
4. Department of Transportation (DOT) refers to the agency that regulates the shipment and movement of Hazardous Materials in commerce.
5. Resource Conservation and Recovery Act (RCRA) refers to a set of rules governing the disposal of hazardous waste.
6. Terminal Distributor of Dangerous Drug (TDD) License refers to a license issued to NEOMED by the Ohio State Board of Pharmacy for the purpose of using regulated drugs for research.

D. Policy Statement

1. NEOMED shall administer a Controlled Substance Program (including a DEA Research registration and Ohio State Board of Pharmacy Terminal Distributor License) compliant with all governing local, state and federal regulations.
   1. The Program shall be responsible for all details as it relates to the administration of the program, including, but not limited to:
      1. Naming a “Responsible Person” to be listed on the TDD and DEA Registration and as a contact for any regulatory inspections.
      2. Maintaining all records.
      3. Coordinating the ultimate disposal of controlled substances with the Office of Environmental Health and Safety (EOHS).
         1. The Program staff will provide a detailed inventory of controlled substances offered for disposal and “non-retrievable” destruction.
         2. EOHS and the Controlled Substance Program will each provide one (1) Staff member to attend the packing and loading of the controlled substances in accordance with DEA regulations.
         3. EOHS will provide a DOT certified staff member to sign any required shipping manifests in accordance with DOT regulations.
         4. All documents relating to controlled substance disposal will be maintained by the Program.
            1. Copies will be maintained by EOHS only as it relates to compliance with RCRA.

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