Controlled Substances

Controlled Substances in Research

UNT Health Science Center requires that all persons conducting activities with DEA-controlled substances in basic and applied research settings shall be registered with the DEA. All persons shall comply with state and federal regulations regarding the acquisition, record keeping, inventory, storage, use, and disposal of those substances.

Questions about procurement, secured storage, use, disposal, required documentation, or regulatory questions regarding controlled substances in research should be directed to the Office of Environmental Health and Safety.

Email to Maya.Nair@unthsc.edu

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. The 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.

Online application for DEA Registration for New users and renewal for existing registrants can be available at https://www.deadiversion.usdoj.gov/online_forms_apps.html

Related Information ( useful links)

Security

Per guidance given by 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 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 as 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.

Ordering or Procurement

Controlled substances must be ordered online using UNTHSC procurement system (ePRO). P-Card can not be used for the purchase of a controlled substance.

Vendors – Authorized Principal Investigator may use any vendor that is authorized to supply requested substances.

Stocks of controlled substances must be kept to the smallest quantity needed.

PI or designated lab member will be initially notified when the order is ready to be picked up from the UNTHSC Central Receiving department.

Only the PI or authorized personnel may pick up controlled substances from the Receiving department.

Persons picking up from central receiving should be sure to get the necessary receiving records to be maintained with the required documents.

Record Keeping

PIs are required by law to maintain complete and accurate inventory records for all controlled substances. These records must be kept separate from all other records and documents, in or near the primary work area, and be available for inspection during regular work hours. The use of codes, symbols, or foreign languages in identifying a controlled substance or person in the record is prohibited. In the event that any controlled substances are lost, destroyed, or stolen, the kind and quantity of the material and the date of discovery of such loss must be recorded in detail. All records must be maintained by PIs for a period of at least two years from the date of the last recorded transaction.

The record-keeping system should include the following information:

Receipt of Controlled Substance: Open and verify contents. Each receiving record must be signed and dated upon receipt by the authorized person receiving the controlled substance. Also document in “Scheduled Drug Inventory Record Year __________” bonded log book.
Use of Controlled Substance: A separate and current record for the use of each controlled substance, indicating the name of the substance, date dispensed, laboratory building/room, finished drug form, total amount on hand and remaining after each use, amount used, authorized user’s signature, and authorized witness’ signature must be documented in the “Scheduled Drug Inventory Record Year” spiral bonded log book.
Disposal of Controlled Substance via Reverse Distributor: Current record indicating the number of commercial containers, quantity per container, date of disposal, how disposed, name, address, and registration number of persons to whom distributed.
Initial Inventory of Controlled Substance: A complete and accurate inventory of the stock of controlled substances within each authorized registrant’s laboratory must be performed initially upon receipt of the DEA license. You must record zero inventories at this time on the “Research Control Substance Bi-Annual Inventory Record”. The authorized person conducting the inventory and authorized witness must also sign the “Research Control Substance Bi-Annual Inventory Record.”
Biennial Inventory: After the initial inventory is taken, a new inventory of all stocks of controlled substances on hand should be conducted every two years. The inventory date and opening or close of business, drug name, strength, quantity, drug form (tablet, capsule, etc), number of units/volume, total quantity, expiration date, name of Principal Investigator, and location must be recorded on the “Research Control Substance Bi-Annual Inventory Record” at this time. The authorized person conducting the inventory and authorized witness must also sign the “Research Control Substance Bi-Annual Inventory Record.”
Authorized Users Signature Log as designated by PI: date signed, printed name, title, signature, initials, and date departed.

NOTE: Bolded words indicate required data per Federal Regulation

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

Initial inventory
Biennial inventory
Daily use logs ( Please specify the time of recording)
Receipt / Disposal records
Authorized user log

Note: the guidance information above is not intended to cover all applicable parts of the DEA rules. For further information on the requirements for controlled substances review

UNTHSC template for DEA_biennial controlled substance inventory form

DEA record-keeping requirement

Registrants inspection by DEA

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.

New Institutional policy for the disposal of expired controlled substances (Office of Internal audit, UNT SYSTEM, August 14, 2018) –Expired controlled substances are disposed of following regular intervals but no later than every six months.

How do I dispose of my controlled substance?

Submit a completed DEA form 41 to EH&S when you have any unused or expired controlled substance for disposal. EH&S will schedule a collection event twice a year (March and September). EH&S will send out an email notification and instructions to all the DEA registrants at UNTHSC. 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.

DEA registrants can also dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples by transferring them to a third-party company that 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.

DEA registrants can also dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples using a reverse distributor. 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.

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.

Some commonly used reverse distributors and their contact information is given below.

Sharps Compliance 713-432-0300

National Pharmaceutical returns 800-770-4725

Inmar 817-868-5300

Please contact Environmental Health and Safety Office (x 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 needs 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 online and submitted to the DEA.

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

Controlled Substances