Controlled Substance Program

1. Control Substance in Research Policy

Controlled Substance Manual

This webpage is intended to provide general guidance for any researcher on campus whose research involves the use of controlled substances.

Complete details and specific requirements mentioned in this site are explained in detail in Title 21 of the Code of Federal Regulations.

Controlled substances exhibit stimulant, depressive, and/or hallucinogenic effects on individuals who consume them and tend to promote abuse oand psychological / physical dependence. DEA website provides a complete listing of controlled substances. Management criteria differ depending on which controlled substances schedule the chemical is listed under.

Before any controlled substance can be purchased by a researcher, a valid DEA registration number must be obtained from the DEA. In addition, researchers must complete the required compliance training on Use of Controlled Substances in Research.

The "Researcher" registration (DEA Form 225 or Renewal 225a) can be applied for by a non-physician and is good for one year. The fee for a Researcher registration can be waived when the license is obtained for work at UNTHSC. During online registration you will be asked to provide an institution representative's name for verification of fee waiver. Use your department chair or dean for research, who can verify your employee status at UNTHSC, a state institution.

Additionally, the State of Texas requires a researcher to register with them after obtaining your DEA registration number.  


Security

Per guidance given from our local DEA office, a drawer that is not transportable (i.e. bolted to the wall), substantially constructed,  and that can be locked will meet the security requirements.

Controlled substances must be stored at the address on the registration. If research involving the controlled substances needs to be conducted at a different location from that listed on the registration, the researcher can transport the controlled substances to the different location so long as it is done within the scope of their employment. The controlled substances must be returned to and secured at the registered location at the end of the day.

In addition, controlled substances that have been diluted with other material(s) must be maintained under lock when not in use.


Recordkeeping

An active inventory must be maintained, in order to make sure controlled substances are not lost, stolen, or misused. This is as important as the physical security measures taken to ensure the proper management  of controlled substances.

Researchers must ensure the following types of records are maintained and made available during an inspection:

1) Initial inventory

2) Biennial inventory

3) Daily use logs

4) Receipt / Disposal records

5) Authorized user log*

*Per UNTHSC policy


Disposal

When there is no longer a legitimate use or need for a controlled susbstance on your DEA registration or if you are in possession of abandoned controlled substances, DO NOT dispose of these materials by dumping them down the sink. This is an unlawful practice and is prohibited by the U.S. EPA. Instead, contact the Office of Research Compliance to have your unwanted controlled substances disposed of in a proper and legal manner.

Once destruction is complete you will receive a copy the destruction records to keep as proof of destruction.


Lost or Stolen Controlled Substances

Any loss, theft, or diversion of any kind related to controlled substances under your registration need to be reported immediately and without delay to the local DEA office (817.639.2000). Additional notification needs to be given to the Office of Research Compliance and the University Police Department so that a formal investigation can be started. In addition, DEA Form 106: Theft or Loss of Controlled Substances, needs to be filled out on line and submitted to the DEA.

NOTE: Only persons registered with and authorized by the DEA to handle controlled substances can utilize/use this form.


Forms

This page last updated 01st May 2013