Handbook of Operating Procedures 7-1510
Controlled Substances in Research
Effective August 23, 2022
Executive Sponsor: Vice President for Research, Scholarship and Creative Endeavors
Policy Owner: Vice President for Research, Scholarship and Creative Endeavors
The University of Texas at Austin (University) is committed to complying with all regulations involving controlled substances including but not limited to federal and state law or regulation.
The U.S. Drug Enforcement Administration (DEA) strictly regulates controlled substances and precursor chemicals. Due to their abuse potential, controlled substances are subject to licensing, registration, storage, security, use, and disposal requirements. In addition, controlled items are subject to specific regulations as agreed to in a Memorandum of Understanding (MOU) between the Texas Department of Public Safety (DPS) and the Texas Higher Education Coordinating Board (THECB).
This policy applies to all employees, students, University affiliates and visitors.
Authorized Users:
refers to personnel designated by the Principal Investigator (DEA Registrant) to have access to controlled substances.
Controlled Items:
refers to chemical precursors, laboratory apparatus, and equipment listed in the MOU between DPS and THECB.
Controlled Substances:
refers to substances and their equivalents regulated under the federal Controlled Substances Act (CSA).
Controlled substances are compounds containing any quantity of substances with a stimulant, depressant, or hallucinogenic effect on the higher functions of the central nervous system, and have the tendency to promote abuse or physiological or psychological dependence, as designated under the CSA.
Controlled Substance Schedules (I-V):
refers to the five groups in which controlled substances are placed according to currently accepted medical use in the United States, potential for abuse, and likelihood for dependence. See DEA Controlled Substance Schedules (https://www.deadiversion.usdoj.gov/schedules/index.html).
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Principal Investigators (PIs) using controlled substances and controlled items in their research (including human and animal research) must comply with applicable laws, regulations, and requirements. These requirements (including licensing/registration) are separate from, and in addition to, any that apply to medical practitioners. All investigators, including clinical practitioners, using controlled substances in research must obtain licensing/registration for use of controlled substances.
It is the responsibility of each PI who purchases or works with controlled substances at the University to register with the DEA and annually provide Environmental Health and Safety (EHS) with copies of their current registration certificate(s). The PI will notify EHS before applying for a registration with the DEA and provide a copy of their DEA registration form. The PI will list the vice president for Research, Scholarship and Creative Endeavors as the authority for DEA fee registration waivers. PIs must adhere to applicable regulatory requirements when working with controlled substances. Activities associated with controlled substances must be conducted at the same general physical location as the registered storage locations of the substances. There can be only one storage location for each registration, and all materials must be securely stored at the storage location specified in the business address on the license and registration.
PIs must complete a DEA Controlled Substance Registration Application. DEA registrations remain active for one year. EHS will notify PIs in advance of their registration renewal date.
Personnel with access to controlled substances are required to have a criminal background check performed by Human Resources. The background check must be conducted prior to being granted access to controlled substances and must include a check for any drug offenses for any employees with access to controlled substances.
Employees convicted of drug-related offenses will be permitted access to Controlled Substances consistent with DEA screening procedures, applicable laws, and University policy. Human Resources will notify the vice president for Legal Affairs and the vice president for Research of personnel convicted of drug-related offenses. The vice president for Legal Affairs and the vice president for Research will together make the determination whether the employee’s access to controlled substances should be denied.
In addition, upon employment and annually thereafter, employees with access to Controlled Substances must respond to questions regarding felony convictions and use of illegal narcotics, amphetamines, or barbiturates. If the employee answers "yes" to any of these questions, the individual reviewing the responses (PI or EHS) will notify Human Resources, the vice president for Legal Affairs, and the vice president for Research.
Employees registered as authorized users will complete University controlled substance training upon employment and every three years thereafter.
PIs are required by law to maintain complete, current, and accurate inventory records for controlled substances. These records must be kept separately from all other records and documents in a dedicated binder or folder. Records for controlled substances listed in Schedules I and II must be kept separate from records for controlled substances listed in Schedules III, IV, and V and in their own dedicated binder or folder. Inventory records must be kept in or near the primary work area at the registered storage location of the substance and be available for inspection. Electronic records are acceptable.
The use of codes, symbols, and foreign languages in identifying a controlled substance or person in the record is prohibited. In the event any controlled substances are lost, destroyed, or stolen, the type and quantity of the material and date of discovery of the loss must be recorded in detail. All records must be maintained by the PI for at least two years from the date of the last recorded transaction. The recordkeeping system must include the information provided on EHS's web page regarding Controlled Substances - Recordkeeping.
In order to prevent theft or diversion, controlled substances, regardless of schedule, must be kept locked at the registered storage location of the drug, and accessible only to authorized personnel. The number of authorized staff must be kept to the minimum essential for operation, and the inventory of controlled substances to the smallest quantity needed.
All controlled substances must be kept locked in their storage location except for at the actual time required for authorized staff to remove, legitimately work with, and replenish them. Controlled substances must be stored in a substantial tamper-proof cabinet which remains securely locked at all times. The room in which the cabinet is located must have limited access during work hours and provide after-hours security. The University of Texas Police Department (UTPD) should be consulted for recommendations regarding security.
Controlled substances possessed, kept, or otherwise stored in a manner or location not in compliance with applicable laws, regulations, and requirements are subject to seizure by and forfeiture to law enforcement officials. Failure to comply with applicable requirements may result in a suspension of purchasing privileges and disciplinary actions.
EHS will conduct annual inspections to ensure compliance with this policy, including a physical inspection of storage and security of controlled substances, verification of personnel background forms, training, and a review of inventory documentation. These inspections may be unannounced. PIs are required to address inspection deficiencies within 14 days of notification. Uncorrected deficiencies will result in a report to the PI’s chair and dean.
PIs are required to complete a Controlled Substances Self-Evaluation annually. The forms, indicating corrective actions taken, must be kept by the PI for a minimum of one year and an electronic copy sent to EHS Lab Safety at ehs-labstaff@austin.utexas.edu. If a PI does not complete a self-evaluation, it will be noted as a deficiency during the annual lab inspection.
Transfers of controlled substances between DEA registered researchers at the University must be completed by authorized users. Transfers will be documented in both the donor's and the recipient’s inventories. The Controlled Substances Chain of Custody Form must be completed and signed by both the donor and the recipient; a copy of this form will remain in the possession of each party as part of the record.
Shipping of a controlled substance to a recipient outside the University requires a Material Transfer Agreement (MTA). Additional approvals may be required.
Expired controlled substances should be disposed of by registrants in accordance with DEA Registrant Drug Disposal regulations related to each element of the disposal process. Expired or unused products must be kept secure until ready for disposal. Expired controlled substances should be disposed of within 90 days. Unused controlled substances may be disposed of only by return via an approved pharmaceutical return company. Orphaned controlled substances must be secured by an official from the responsible college/department until transferred to the DEA for destruction.
All waste containing controlled substances must be disposed of in compliance with applicable regulations including but not limited to federal and state law and regulations. Controlled substances injected into research animals or consumed in a reaction must go into a hazardous waste stream for disposal through the University's hazardous waste disposal program. EHS must grant approval prior to generation of all other wastes containing controlled substances.
Theft, suspected theft, unauthorized use, and other losses of any controlled substance must be reported to UTPD and EHS upon discovery (no later than the end of the work day). This includes any discrepancies in recordkeeping.
Licensees leaving the University must transfer all controlled substances to another DEA licensee or dispose of their controlled substances by a pharmaceutical return company. The licensee’s supervisor will notify EHS of the licensee’s employment termination. All controlled substances will be transferred or disposed of before the licensee leaves the University. EHS will notify the DEA of the licensee’s employment termination.
Any person with specific authority to purchase or accept controlled items must bear full responsibility for establishing the necessary security measures regarding their purchase, acceptance, use, and ultimate disposal
PIs and lab personnel shall establish specific locations where controlled items are utilized and/or stored, lock all doors/windows when the room is not occupied, establish key control and restrict room access to authorized personnel, establish procedures to assure proper use of controlled items in laboratories and storerooms, be aware of unauthorized personnel in the laboratory, be alert and attentive to disappearance of controlled items, and report losses of controlled items to UTPD. PIs and lab personnel shall not send controlled items to Surplus Property
PIs and lab personnel shall review and comply with the MOU between DPS and THECB as referenced above in Section II. Reason for Policy
None
EHS DEA Controlled Substances Requirements and Process
DEA Controlled Substances Schedules
DEA Controlled Registration Application
EHS Hazardous Waste Disposal
HOP 4-1020 - Key Control and Accountability
Origination date: January 17, 2017
Modified: August 23, 2022
Editorial revisions: February 8, 2023
Next Scheduled Review: August 2025
