Use of List I and II Chemicals in Research on the NEOMED Campus: Drug Enforcement Agency Guidelines

Policy Number: 3349-R-675
Effective Date: 04/04/2018
Updated: —
Reviewed: —
Responsible Departments: ORSP, Compliance (EOHS)
Approval Authority: VP Research
Responsible Office: EOHS

A. Purpose

The purpose of this policy is to provide guidance on the process for obtaining, maintaining, and disposing of Drug Enforcement Agency (DEA) restricted List I and List II chemicals.

B. Scope

This policy applies to all personnel on the NEOMED Campus.

C. Definitions

1. “Authorized Purchaser” refers to a university designee who has knowledge of the proper use of the list I chemical or list II chemical or is the legally authorized user of the chemical. According to 21 CFR 1310.07, “Each regulated person who engages in a regulated transaction must identify the other party to the transaction. For a domestic transaction, this shall be accomplished by having the other party present documents which would verify the identity or registration status of a registrant, of the other party to the regulated person at the time the order is placed.” For purposes of Research, the Department Chairs (or designee) will be the authorized signer for purchasing of list I and list II chemicals for their area(s) of responsibility.
2. “List I Chemical” refers to a chemical specifically designated by the Administrator in 21 CFR 1310.02(a) that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Controlled Substances Act (herein referred to as ‘the Act”) and is important to the manufacture of a controlled substance.
3. “List II Chemical” refers to a chemical, other than a List I chemical, specifically designated by the Administrator in 21 CFR 1310.02(b) that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Controlled Substances Act.

D. Policy Statement

1. NEOMED supports the efforts of the DEA of the U.S. Department of Justice Chemical Control Program to prevent the diversion of chemicals that may be used in the illicit production of controlled substances (or “drugs of abuse”). Therefore, the following are the procedures for obtaining, maintaining, and disposing of DEA restricted List I and List II chemicals.
   1. Use of list I and II chemicals. NEOMED’s Research DEA license is currently administered by the Comparative Medicine Unit (CMU). A DEA licensure (registration) is not required but is recommended for those authorized to purchase list I and list II chemicals.  In lieu of a DEA licensure, a chemical substance license can be obtained, but is not specifically required. A Department Chair (or designee) in good standing will be recognized as meeting the intent of this policy. Each individual researcher does not have to register according to 21 CFR 1309.24, which states: “The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment.”
   2. Redistribution/ Illicit use. Employees of NEOMED are prohibited from redistribution of any List I or II chemicals. The Act requirements for manufacturer, distributer, importer or exporter may apply and the regulations may be much different or more burdensome. In accordance with 21CFR 1309.72, employees who sell, use or divert listed chemicals for illicit use subject themselves to state and federal prosecution as well as potential discipline in accordance with University policy.
   3. Control Access Employer responsibilities. NEOMED shall exercise caution in the consideration of employment of persons who will have access to listed chemicals, who have been convicted of a felony offense relating to controlled substances or listed chemicals, or who have, at any time, had an application for registration with the DEA denied, had a DEA registration revoked, or surrendered a DEA registration for cause.
   4. Records.  All personnel (defined as faculty, students or staff engaged in authorized research) should maintain accurate records of the intake (amount received), use, purpose and amount offered for disposal of any list I and II chemicals. For example, iodine used to disinfect maybe documented by the invoice received, number of swabs used, per number of days. Other examples might be signed/ dated packing slip and a tamper resistant log. Records should be maintained for a minimum of three years and readily producible upon request or inspection.
   5. Disposal of List I and II chemicals. List I and List II chemicals will be disposed of in accordance with all federal, state and local regulations and University policy as coordinated through the Office of Environmental and Occupational Health and Safety. A record of this disposal including the date, the amount, and a copy of the log is required and will also be maintained for three years in the same fashion as the intake records.
   6. List I and II Chemicals

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