Controlled Substances in Research

Handbook of Operating Procedures 7-1510

Controlled Substances in Research

I. Policy Statement 

The University of Texas at Austin ("University") is committed to complying with federal and state regulations involving controlled substances and controlled items.

II. Reason for Policy 

The federal Drug Enforcement Agency ("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 Higher Education Coordinating Board ("THECB") and the Texas Department of Public Safety ("DPS").

III. Scope & Audience 

This policy applies to all employees, students, University affiliates and visitors.

IV. Definitions (specific to this policy) 
Controlled Items:

refers to chemical precursors, laboratory apparatus, and equipment listed in the MOU between THECB and DPS.

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.

V. Website (for policy) 
https://policies.utexas.edu/policies/hop/7-1510
VI. Contacts 
Contact Details Web
Environmental Health and SafetyPhone:512-471-3511Website:
VII. Responsibilities & Procedures 

Principal Investigators ("PIs") using Controlled Substances in their laboratory research (including animal research) are subject to federal, state and University requirements. These requirements (including licensing/registration) are separate from, and in addition to, any that apply to medical practitioners. MDs/PhDs conducting laboratory research must obtain licensing/registration for laboratory use of Controlled Substances.

 

  1. Licensing and Registration

It is the responsibility of each PI who purchases or works with Controlled Substances at the University, to obtain a DEA Controlled Substance researcher registration 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 as the authority for DEA fee registration waivers. PIs must adhere to applicable state and federal regulatory requirements when working with Controlled Substances. The activity associated with the Controlled Substance must be conducted at the registered storage location of the drug. There can only be one storage location for each registration, and all materials must be securely stored at the storage location specified 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.

 

  1. Background Check

The DEA requires personnel with access to Controlled Substances to have a criminal background check performed by Human Resources prior to access to Controlled Substances. The background check must include drug offenses for any employees with access to Controlled Substances.

 

Employees convicted of drug-related offenses will only be permitted access to Controlled Substances consistent with DEA screening requirements, federal and state law, 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 will be contacted by EHS and must respond to questions regarding felony convictions and use of illegal narcotics, amphetamines, or barbiturates. If the employee answers "yes" to these questions, EHS will notify Human Resources, the Vice President for Legal Affairs, and the Vice President for Research.

 

  1. Training

Employees registered as authorized users will complete University Controlled Substance training upon employment and every three years thereafter.

 

  1. Inventory Recordkeeping

PIs are required by law to maintain complete, current, and accurate inventory records for Controlled Substances. These records must be kept separate, in or near the primary work area at the registered storage location of the drug, and be available for inspection. Electronic records are acceptable.

 

The use of codes, symbols, or 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 PIs for a period of 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.

 

  1. Storage and Security

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. Expired Controlled Substances should be disposed of within 90 days.

 

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 replenish them.  Controlled Substances must be stored in a substantially constructed tamper-proof cabinet which remains 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 state or federal law is subject to seizure by and forfeiture to federal or state officials. Failure to comply with applicable requirements may result in a suspension of purchasing privileges and disciplinary actions.

 

  1. Inspections

EHS will conduct annual inspections to ensure compliance with this policy. This includes 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 receipt. Uncorrected deficiencies will result in notification to the PI’s chair and dean.

 

  1. Self-Evaluation

PIs are required to complete a Controlled Substances Self-Evaluation on an annual basis. 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.

 

  1. Transfers and Shipping

Campus transfers of Controlled Substances between DEA registered researchers must be completed by authorized users or EHS/UTPD. Transfers will be documented in both the donor and the recipient’s inventories. Shipping of a Controlled Substance to a recipient outside UT Austin requires a Material Transfer Agreement ("MTA"). Additional approvals may be required.

 

  1. Disposal

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 product must be kept secure until ready for disposal. Orphaned Controlled Substances must be transferred to another licensee or to UTPD. Controlled Substances may only be disposed of by returning via an approved pharmaceutical return company. Controlled Substances injected into research animals, consumed in a reaction, or irrecoverably co-mingled (if part of the research protocol) must go into a hazardous waste stream for disposal through the University's hazardous waste disposal program.

 

  1. Reporting of Loss, Destruction, Theft, or Unauthorized Use

Theft, suspected theft, unauthorized use, or 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.

 

  1. Termination of Employment

Licensees leaving the University must transfer all Controlled Substances to licensed UT Austin recipients or dispose of their Controlled Substances by a pharmaceutical return company. 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.

 

  1. Controlled Items

Section Reserved

VIII. Forms & Tools 
XI. History 

Next Scheduled Review Date: 01/17/19