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 and 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.

Effective September 1, 2016 Texas Controlled Substances Registrations are no longer required. Active and current DEA registrations are still required. Contact your state licensing board for more information. https://www.dps.texas.gov/csr/index.aspx

Related information ( useful links)

Drug Enforcement Agency

DEA Controlled Substances Schedules

DEA Controlled Registration Application

Office of Diversion Control – Online Registration Applications

 


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.


Record keeping

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 ( Please specify the time of recording)

4) Receipt / Disposal records

5) Authorized user log*

*Per UNTHSC policy

DEA record keeping requirement

 

 


Disposal

When there is no longer a legitimate use or need for a controlled substance 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.

How do I dispose of my controlled substance?

You may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a third party company who is authorized to receive such materials. These commercial operators are referred to as reverse distributors. Schedule I and schedule II controlled substances should be transferred via the DEA form 222, while schedule III–V substances may be transferred via invoice. The licensed researcher must maintain copies of the records documenting the transfer and disposal for a period of at least 2 years after disposal of a controlled substance. There is a charge for the use of a reverse distributor. The cost of waste disposal depends on the type and quantity of the substance. You may also try contacting the manufacturer to request authorization to return the controlled substances directly to them.

 

Who are the ‘reverse distributors’?

Reverse distributors (third party companies) are registered with DEA and are authorized to receive out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including unwanted bulk controlled substances samples from DEA licensed researchers and dispose of the waste(s) by appropriate DEA procedures.

 

Please contact Environmental Health and Safety Office ( extn 5431) if you have any questions.


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 was last modified on January 5, 2018