Due to their abuse potential, items identified by the US Department of Justice, Drug Enforcement Administration (DEA) as controlled substances are subject to licensing, registration, storage, security, use, and disposal requirements.
Controlled substances are materials containing any quantity of a substance with a stimulant, depressant, or hallucinogenic effect on the higher functions of the central nervous system, and having the tendency to promote abuse or physiological or psychological dependence, as designated in state and federal controlled substance schedules. See a list of DEA controlled substances.
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, i.e., MDs. MDs/PhDs conducting laboratory research must obtain licensure/registration for laboratory use of controlled substances.
HOP 7-1510 - Controlled Substances in Research
The University developed a Controlled Substances in Research policy outlining the responsibilities and procedures for PIs using controlled substances in their laboratory research. This policy applies to all employees, students, University affiliates and visitors.
Licensing and Registration
- Federal Registration: Complete a DEA Controlled Substance registration application. DEA registrations remain active for a 1-year period.
Note: Copies of all registration and licensing related correspondence must be kept by the PI with additional copies sent to Environmental Health and Safety.
UT policy requires that each PI complete a Controlled Substances Self-Evaluation (PDF) 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 EHS Lab Safety.
Storage and Security Controls
Controlled substances possessed, kept, or otherwise stored in a manner or location not in compliance with state or federal law is subject to seizure by and forfeiture to federal or state officials. Failure to comply with applicable requirements may also result in a suspension of purchasing privileges and disciplinary actions.
In order to guard against theft or diversion, all controlled substances - regardless of schedule ¬must be kept under lock and key, and accessible only to authorized personnel. The number of authorized staff must be kept to the minimum essential for operation, and the stocks of controlled substances to the smallest quantity needed.
All controlled substances must be kept locked in their storage location except for the actual time required for authorized staff to remove, legitimately work with, and replace them.
Controlled substances must be stored in a substantially constructed cabinet. This cabinet must be kept locked at all times. The room in which the cabinet is located must have limited access during working hours and provide security after hours.
Controlled substances may only be disposed by returning to a reputable pharmaceutical return company. Expired material or unused product must be accumulated and stored under lock and key until ready for disposal. Controlled substances injected into research animals, consumed in a reaction, or irrecoverably comingled (if part of the research protocol) go into a hazardous waste stream for disposal through the University's routine waste disposal program.
The license holder is responsible for disposal, but EHS can reimburse license holders for controlled substance disposal costs. Contact
email@example.com for further information.
Reporting of Loss, Destruction, Theft, or Unauthorized Use
Thefts, suspected thefts, unauthorized uses, or other losses of any controlled substance must be reported to the UT Police Department (UTPD) and EHS upon discovery. Registrants must also document the incident to the federal DEA. See DEA Theft or Loss of Controlled Substances.
PIs are required by law to maintain complete and accurate inventory records for all controlled substances. These records must be kept separately 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 recordkeeping system should include the following information:
- Receipt of Controlled Substance(s): A separate and current record on the receipt of controlled substances, indicating date received, name and address of supplier, and the type, strength or concentration, and amount of the controlled substances received. Each record must be signed by the person receiving the controlled substance.
- Use of Controlled Substance(s): A separate and current record for the storage and use of each controlled substance, indicating the date, laboratory building and room, specific research experiment, controlled substance's application in the research, and type, strength and quantity of each controlled substance use or disposal. By noting starting volume or mass of substance in the container, each use or disposal is a subtraction from the starting quantity, and the running (decreasing) amount should equal the total amount remaining on-hand. Each record of use must be signed by the person working with the controlled substance.
- Inventory of Controlled Substance(s): A complete and accurate inventory of the stock of controlled substances within each registrant's laboratory must be performed initially. The type, strength, and quantity of all controlled substances must be recorded at this time. The person conducting the inventory must also date and sign the record. After the initial inventory is taken, a new inventory of all stocks of controlled substances on hand should be conducted at least every two years. PIs should be sure that the inventory can be reconciled to the records of receipt, use and disposal at all times.
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 the DEA website.