UTDPP1042
Management of Controlled Substances

Policy Statement

Purpose

This policy establishes minimum standards for controlled substance procurement, storage, and use within The University of Texas at Dallas (UTD) and should be followed concurrently with the policies and procedures found in Policy Memorandum 01-III.27-84 Controlled Items, Precursor Chemicals, and Chemical Laboratory Apparatus. The purpose of these policies is to maintain compliance with the Code of Federal Regulations [C.F.R.] 21 Part 1300 to end) and applicable state statutes, and to minimize diversion of controlled substances.

Scope

This policy applies to DEA Schedules I-V controlled substances in basic and applied research and instructional settings.

Responsibilities

Faculty members who purchase, receive, use, or intend to use controlled substances in research or teaching are responsible for obtaining and maintaining their registration from the US Department of Justice, Drug Enforcement Administration (DEA). Applications for registration must be obtained through the DEA’s website. Registrants must renew their registration annually through the DEA’s website. The DEA will only send an electronic reminder via email to the email address associated with the DEA registration.

Faculty members who purchase or receive controlled substances are responsible for all aspects of authorized user training, security, record keeping, use, and disposal as described in this policy.

Approval and Use

Research Protocols utilizing controlled substances are reviewed for approval by the University’s Institutional Animal Care and Use Committee (IACUC), and/or the UTD Institutional Biosafety and Chemical Safety Committee (IBCC).

1. The University Veterinarian may bring controlled substances to campus to be used in procedures on animals that they personally conduct in the animal facility. They may not house any controlled substances in the campus animal facility.
2. Faculty members wishing to use controlled substances in research may not handle substances prescribed by the University Veterinarian unless they apply for and obtain an individual DEA registration.

Procurement and Transfers

All controlled substances shall be purchased through the University Purchasing Office utilizing a University Purchase Order through eProcurement. An authorized approver will approve the purchase in the eProcurement system. All controlled substances shall be received at the Central Receiving Office.

1. The DEA registrant or designated authorized user of the registrant must sign for the controlled substance package. The package(s) shall be immediately checked for accuracy. Any discrepancies or deviations from what was ordered, that cannot be accounted for by the supplier, must be reported immediately to the University Police Department. All purchasing and receipt paperwork (P.O., Invoice, and Packing List) associated with an incoming DEA order shall be signed, dated, and filed.
2. Transfer of controlled substances between registered Investigators is allowed in accordance with 21 C.F.R. §1301.52.completed.
3. Transfers to and from points outside of UTD are on a case-by-case basis and must be approved through the Office of Research Innovation and comply with 21 C.F.R. §1301.52.

Security

DEA registrants are responsible for establishing and maintaining effective controls and procedures against unauthorized access to controlled substances.

1. All controlled substances (DEA Schedules I-V) must be stored and securely locked behind at least three sets of locks, in a substantially constructed cabinet or security cabinet in accordance with 21 C.F.R § 1301.72. Access to controlled substance storage must be limited to only those individuals specifically authorized to use controlled substances.
   No employee who has been convicted of a felony or any state or federal law regarding controlled substances may be allowed access to controlled substances. All employees with access to controlled substances must consent to a background check regarding conviction of a felony or any state or federal law pertaining to controlled substances. The background checks will be requested through the University Human Resource Office for staff members (UTD Police for others) by the DEA registrant.

Records

Complete and accurate records pertaining to controlled substances (DEA Schedules I-V) must be maintained for at least two years plus the current year in the event of a DEA inspection. These records include, but are not limited to purchase and receipt documentation, transfer logs, usage logs, and disposal records.

Usage logs must be in a bound book, free of any white-out or heavy mark out, readable, and in good condition. Any handwritten error must be clearly corrected, using a single line through the error, and initialed.

Disposal

All expired controlled substances, or controlled substances to be discarded must be transmitted to the University Safety Officer.

Loss or Theft

Any loss or theft of controlled substances shall be reported immediately by the DEA registrant or authorized user(s) to the University Police Department and the Office Risk and Safety. It is the DEA registrant's responsibility to also contact the DEA within the specified time requirement.

Inspections

All facilities where controlled substances are used or stored will be inspected for compliance at least annually.

Terminations

A DEA Registrant that no longer requires the use of controlled substances in their research, plans to move their storage location, or leaves the University's employment shall notify the DEA promptly. In a voluntary surrender, registration termination shall occur when the DEA receives a signed statement indicating the desire to surrender the registration. Any remaining controlled substances can be transferred to an authorized DEA registrant at the University or disposal arranged through an authorized reverse distributor.

The registration should not be terminated until all controlled substances have been transferred or disposed of properly with an authorized reverse distribution vendor. If a researcher has their registration revoked by the issuing agency, this will be an immediate termination of the ability to possess and use controlled substances.

Controlled substances in the possession of a registrant with a terminated DEA registration shall be considered abandoned and the DEA will be contacted to assist with disposal.