The Office of Research Integrity and Outreach oversees and provides guidance and procedures for proper management of controlled substances at The University of Texas at Dallas. Laboratories using or planning to use controlled substances are required to comply with UT Dallas Controlled Substances policies and all applicable regulations.
Controlled substances are typically chemicals or drugs that can be used as analgesics, anesthesia, euthanasia, and/or steroids and have a tendency to promote abuse or physiological or psychological dependence. The U.S. Department of Justice Drug Enforcement Administration (DEA) regulates licensing, registration, storage, security, use, and disposal requirements of controlled substances. The Texas Department of Public Safety and UT Dallas Policy (UTDPP1041) regulate chemical precursors and chemical laboratory apparatus.
Regulation of Controlled Substances
Regulatory information about controlled substances can be found under The Controlled Substances Act (CFR Title 21 Chapter 13 Subchapter I) and U.S. Department of Justice Drug Enforcement Administration (DEA) Diversion Control Division.
State and local information about precursor chemicals and specific laboratory apparatus can be found at the Texas Department of Public Safety – Regulatory Services under Precursor Laboratory Apparatus.
Controlled Substances: Definition and Schedules
Controlled substances are chemicals that may be addictive, abused, and illegal to possess without proper licensing and registration. The manufacture, possession, use, and proper disposal of controlled substances are therefore regulated by the DEA. Click here for a complete List of DEA Controlled Substances. Additional list information about schedule actions, controlled substances, and regulated chemicals can be found in the DEA Orange Book.
Proper Controlled Substance Management
Principal Investigators (PIs) using controlled substances in their laboratory research (including animal research) are subject to state and federal regulatory requirements. Please note that these requirements (including licensing/registration) are separate from, and in addition to, any that apply to medical practitioners. MDs/PhDs conducting laboratory research also must obtain licensure/registration for laboratory use of controlled substances.
Licensing and Registration
Each researcher who intends to work with DEA controlled substances in their laboratory must obtain and maintain registration with the DEA. This allows the licensed researcher to purchase, use, and dispose of controlled substances. The registration and licenses must be accessible upon request for inspection. Registered researchers must comply with all state and federal regulatory requirements while working with controlled substances.
Note: Copies of all registration and licensing documents must be kept; additional copies must be submitted to Research and Academic Safety.
Research and Academic Safety Inspections and Self-Evaluation
UT Dallas Research and Academic Safety performs regular inspections to help ensure compliance with the regulations. UT Dallas policy requires that each PI complete a Controlled Substances Self-Evaluation form annually. The forms, indicating corrective actions taken, should be kept by the PI for at least one year, and a copy should be submitted to Research and Academic Safety. In addition, all authorized users are required to complete an annual Controlled Substance training to review DEA requirements and UT Dallas policy.
Storage and Security
All controlled substances must be stored securely with limited access by authorized individuals only. Detailed information about general security requirements can be found here. These requirements must be followed to avoid theft or diversion which may lead to a violation of federal laws. Failure to comply could lead to seizure and suspension of operations.
Storage and Security requirements are as follows:
- Must be stored behind a minimum of two (2) locks (i.e. locked safe within a locked room).
- Both the room and safe must stay locked except when being used.
- The safe must be secured to the floor or building structure.
- Access codes, badges, and/or keys should be limited.
- Limit time that controlled substances are out.
- Never leave controlled substances unattended.
- Only allow authorized users to handle them.
- Never take controlled substances out of the secured area.
Do not submit online waste pickup requests for Controlled Substances. Research and Academic Safety will coordinate the disposal. Contact firstname.lastname@example.org to request a pickup and complete the electronic waste inventory form they email. You must have a current license to dispose of controlled substances.
All expired or unused materials must be securely locked in the same manner as described under Storage and Security. Controlled substances injected into research animals, consumed in a reaction, or irrecoverably comingled (as part of a procedure) can be disposed of as hazardous waste and requested with normal hazardous waste disposal procedures.
Diversion and Loss Reporting
Diversion is the act of using a controlled substance obtained legitimately for illegitimate purposes. This can include:
- Theft and suspected theft
- Unauthorized uses
- Other losses of any controlled substance
Any discrepancies in Use Logs or disposal records are considered diversions and will be subject to internal investigations by campus authorities.
Federal Law requires you report any incidents immediately to UT Dallas PD and the DEA within 24 hours of a loss.
In addition, any illicit activities (i.e. illegally possess, sell, use, or divert controlled substances) is a violation of Federal Law and University policies and is subject to legal action.
Recordkeeping is a vital part of managing controlled substances. Complete and accurate records help maintain inventories to avoid diversions and losses. Logbooks and records should be separated from other records and kept near the controlled substance work area. These records must be understandable; use of codes, symbols, or foreign languages is prohibited. Events of loss, destruction, or theft must be recorded in detail as well. All records and logbooks must be retained for at least two years from the last entry.
Records and logbooks should include:
- Receipt of Controlled Substances: These records should indicate date received, name and address of supplier, substance name and description, amount received, and authorized person handling the substance.
- Use Log of Controlled Substance: Each controlled substance should have its own use log. Different substances shouldn’t be recorded interchangeably. Information in the Use Logs should minimally include:
- Name of Controlled Substance
- Date (i.e. Received, Expired, Each time used)
- Amount (i.e. Initial, Dispensed, Remaining)
- Purpose of use (i.e. Project or Experiment used for)
- Authorized User Name/Initials
- Witness Name and Signature
- Inventory of Controlled Substance: This complete and accurate inventory of controlled substances stocked in each registrant’s laboratory should be conducted initially when registered and biennially (every two years). These records must be consistent with records of receipt, use, and disposal.
Note: The information provided above and in training is not intended to cover all aspects of DEA regulations governing Controlled Substances. Further information on requirements for managing controlled substances can be found on the DEA website. You may also contact Research and Academic Safety for questions, concerns, and clarification.