Handbook of Operating Procedures
Chapter 10 - Research
Policy Reviewed Date: March 15, 2022
Publication Date: March 15, 2022
Policy Owner: VP for Research

10.17 Controlled Substances in Research

I. POLICY STATEMENT

The University of Texas at San Antonio (UTSA) provides administrative and procedural support to Principal Investigators (PIs) who possess and use Controlled Substances and precursor chemicals in research. PIs are the License Holders (Registrant) responsible for complying with U.S. Drug Enforcement Administration (DEA) licensing, registration, storage, recordkeeping, and security requirements.

II. RATIONALE

UTSA does not act in the capacity of a License Holder nor does it regulate the licensing and registration of Controlled Substances for PIs. Rather, UTSA provides administrative and procedural support to PIs in their compliance with state and federal laws relating to Controlled Substances. This policy describes that support.

III. SCOPE

This policy applies to anyone using Controlled Substances in research that utilizes UTSA resources or facilities.

IV. WEBSITE ADDRESS FOR THIS POLICY

http://www.utsa.edu/hop/chapter10/10.17.html

V. RELATED STATUTES, POLICIES, REQUIREMENTS OR STANDARDS

UT System Policies or the Board of Regents' Rules & Regulation
1. UT Board of Regents’ Rule 30103: Standards of Conduct
Other Policies and Standards
1. Memorandum of Understanding between the Texas Higher Education Coordinating Board and the Texas Department of Public Safety
2. Texas Health and Safety Code Chapter 481, Texas Controlled Substances Act
3. 21 U.S.C. §811, Controlled Substances Act
4. 21 CFR 9 Chapter II, Drug Enforcement Administration, Department of Justice
5. 21 U.S.C. 823 Registration requirements
6. 21 U.S.C. 958 Registration requirements

VI. CONTACTS

If you have any questions about this Controlled Substance in Research Policy, contact the following office(s):

The Office of Laboratory Safety at 210-458-6697 or
The Office of Research Integrity at 210-458-4531

VII. DEFINITIONS

Registrant License Holder (“Registrant”)
1. Any person who is registered pursuant to either §303 or §1008 of the Controlled Substances Act (21 U.S.C. 823 or 958). Registrants may only be UTSA employees unless explicitly authorized by the Vice President for Research, Economic Development, and Knowledge Enterprise.
Controlled Substance
1. A drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of Title 21 CFR §1308.11 through §1308.15 and schedules I, II, III, and IV of the Texas Controlled Substances Act.
2. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
Authoritzed Person
1. Individual with Power of Attorney granted by Registrant to order Controlled Substances on the Registrant’s behalf. This authorization is documented in the Power of Attorney Form (Section XI, Form 6 of this Policy).

VIII. RESPONSIBILITIES

Registrants
1. Obtain and maintain Controlled Substances registration from the DEA.
2. Oversee all work conducted with Controlled Substances and ensure it follows federal, state, local and tribal laws, and regulations as well as UTSA policies.
3. Complete training requirements regarding the use of Controlled Substances.
4. Complete a Power of Attorney form for Authorized Persons (see Section XI, Form 6).
5. Oversee activities conducted by Authorized Persons.
6. Cooperate with DEA and Laboratory Safety Division inspections.
7. Report deviations from this Policy to DEA and the Laboratory Safety Division.
8. Report theft and any compromised security controls.
9. Maintain inventory and records in a designated secure location (the location should be on file with the Laboratory Safety Division) in accordance with this Policy and relevant Federal and State regulations.
10. Conduct a self-evaluation at least annually and submit results to the Laboratory Safety Division.
11. Maintain keys or passcodes to storage devices securely.
12. Promptly report spills, loss, and theft to the UTSA Police Department (UTSAPD), Laboratory Safety Division, and to the DEA according to 21 CFR 1301.74(c), including submission of DEA Form 106.
13. Report any convictions of drug-related offenses of self, staff, or students, to the Laboratory Safety Division. The Laboratory Safety Division will then notify the appropriate divisions at UTSA for compliance and safety purposes.
Authorized Person
1. Be authorized, via Power of Attorney, to order Controlled Substances on behalf of the Registrant.
2. Submit Power of Attorney form (Form 6) to the Purchasing Department (purchasing@utsa.edu).
Laboratory Safety Division
1. Maintain copies of all Registrant’s certificates.
2. Inspect Registrant’s laboratory at least annually and maintain a record of the inspection.
3. Provide guidance to Registrants and the University community regarding reporting procedures, inventory requirements, proper disposal, and records maintenance.
4. Report Controlled Substance program deviations to the Associate Vice President of Research Integrity and the DEA (if there is a regulatory deviation).
5. Provide access to training resources for personnel using Controlled Substances at utsa.bioraft.com.
6. Provide a labelled binder containing resources to support the maintenance of Controlled Substances records and inventories.
7. Arrange for removal of Controlled Substances from Registrant upon notification that (1) a Registrant has surrendered their DEA license, (2) the DEA license has been revoked, or (3) any regulatory, security, or safety reason.
UTSA Police Department
1. Provide guidance to Registrant regarding security procedures.
2. Investigate reports of theft or criminal activity related to Controlled Substances.
3. Assist the Laboratory Safety Division in removal of Controlled Substances.
People Excellence
1. Notify the Chief Legal Officer and the Vice President of Research, Economic Development, and Knowledge Enterprise of personnel working with Controlled Substances who have been convicted of drug-related offenses.
Vice President of Research, Economic Development, and Knowledge Enterprise
1. Verify that the researcher is an employee of UTSA during the initial license application.

IX. PROCEDURES

REGISTRATION, SECURITY, AND INSPECTIONS
1. Protocol Review and Registration with the DEA
  1.1 Prior to beginning research, obtain applicable approval from the appropriate UTSA compliance or safety committee such as Institutional Review Board (IRB),Institutional Care and Use Committee (IACUC), Chemical Safety Committee (CSC), Institutional Biosafety Committee (IBC), Radiation and Laser Safety Committee (RLSC), and any other required approval committees not listed here. Contact the Laboratory Safety Division for guidance.
  1.2 Complete DEA’s New Application for Registration (currently Form 224). DEA Registration information and application forms are located on DEA’s website using their online registration tool at https://www.deadiversion.usdoj.gov/drugreg/. For research using Schedule I Controlled Substances, provide a copy of the research protocol containing the information set forth in 21 CFR 1301.18 during the registration process. Submit a copy of the UTSA committee’s approval for the research protocol to DEA.
  1.3 Send a copy of the current registration certificate(s) to the Laboratory Safety Division.
  1.4 Complete DEA Form 225a for annual renewals and send each renewal certificate to the Laboratory Safety Division.
2. Location of Registration
  2.1 DEA Registrations are location specific, i.e., a researcher must obtain a separate DEA Registration for each site at which they perform research using Controlled Substances. The DEA limits Controlled Substances shipments to the specific location listed on a DEA Registration according to the permitted use by the Registrant.
3. Registration for Employees/Agents who assist in Controlled Substances Research
  3.1 Employees, graduate students, or visiting researchers working for or on behalf of the Registrant may work with the Controlled Substances in carrying out their usual course of employment / course of study, provided they are under the supervision and control of the Registrant. Registrants, personnel, and students in labs where Controlled Substances are held must complete training in:
  3.1.1 what Controlled Substances will be used in the research;
  3.2.1 how the Controlled Substances will be used in the research;
  3.3.1 security measures that must be taken with regard to the Controlled Substances;
  3.4.1 record-keeping activities, such as inventories, use, and dispensation logs;
  3.5.1 procedures for reporting any suspected loss or diversion of Controlled Substances; and
  3.6.1 disciplinary or personnel actions that will be taken if Controlled Substance protocols and lab procedures are not followed.
4. Security and Storage of Controlled Substances
  4.1 All Controlled Substances should be stored in their original, labeled containers and stored separate from general chemicals.
  4.2 To prevent theft or diversion, Registrants will keep Controlled Substances, regardless of schedule, locked at the registered storage location and accessible only to approved personnel. Registrants will keep the number of approved staff to the minimum essential for research activities and the inventory of Controlled Substances to the smallest quantity needed. Registrants should dispose of expired Controlled Substances within a timely manner and in accordance with this policy.
  4.3 All Controlled Substances must be kept locked in their storage location except for the actual time required for authorized staff to remove, legitimately conduct research with, and replenish them. Controlled Substances must be stored in a substantially constructed tamper-proof cabinet that always remains locked. Storage must provide at least two levels of security, such as a locked cabinet within a locked room, or a lockbox within a locked cabinet. Registrants must follow storage specifications detailed in 21 CFR 1301.72.
  4.4 The room in which the cabinet is located must have limited access during the laboratory’s work hours and provide after-hours security. The UTSAPD can provide security recommendations.
  4.5 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. Additionally, failure to comply with applicable requirements may result in a suspension of UTSA purchasing privileges and other disciplinary actions.
  4.6 A Registrant must immediately report loss or theft of access control devices/measures (e.g., keys, combinations, codes) to the UTSAPD (210-458-4242), UTSA’s Laboratory Safety Division (210-458-6697) and the DEA. A Registrant must instruct all those who work for them, and whose work involves Controlled Substances, to immediately report to Registrant any loss, theft, or compromise of access control devices/measures. Registrant is responsible for replacing that compromised access control devices/measures (e.g., re-key locks, change authorization code, etc.).
  4.7 If there is spill, loss, or theft of Controlled Substances the Registrant must report the incident immediately to UTSAPD (210-458-4242), the Laboratory Safety Division (210-458-6697) and the DEA according to 21 CFR 1301.74(c), including submission of DEA Form 106. It is the responsibility of the Registrant to ensure all personnel working with Controlled Substances in the laboratory are aware of reporting polices. Reports to these agencies are also required for suspected or actual tampering with inventory records, loss and/or theft of inventory records. If the security of the location of the Controlled Substances is breached in any way the Registrant shall inventory the Controlled Substances.
5. Personal Security
  5.1 The Registrant cannot hire or utilize any employee, student, volunteer, visiting researcher or agent whose work requires them to have access to Controlled Substances if that person has been convicted of a felony relating to Controlled Substances, or has had a DEA Registration denied, revoked, or surrendered for cause. Potential employees shall undergo a routine criminal background check as required by UTSA People Excellence. The Registrant must require all employees, students, volunteers, visiting researcher and other agents who will be working with Controlled Substances to complete a self-disclosure form annually. Registrants will keep the self-disclosure forms in a secure file. During research, any employee, student, volunteer, visiting researcher or agent convicted of a felony relating to Controlled Substances or have had a DEA Registration denied, revoked, or surrendered for cause, must immediately report such events to Registrant and their access to Controlled Substances must be immediately revoked.
6. Inspections
  6.1 By law, agents of the DEA or other authorized licensing, police or law enforcement agencies may conduct inspections of registered sites.
  6.2 The Laboratory Safety Division will conduct evaluations of the Controlled Substance program in the laboratory at minimum annually. This evaluation may be announced or unannounced and will include a physical inspection of storage and security, verification of personnel records, and inventory documentation. Registrants must correct inspection deficiencies immediately. The Laboratory Safety Division staff will report observations to the DEA as required by law.
  6.3 Registrants shall conduct a self-evaluation of the program at minimum annually and submit the results of the evaluation to the Laboratory Safety Division. Registrants must immediately report self-identified deficiencies to the appropriate authority, depending on the nature of the deficiency. The Laboratory Safety Division can assist the Registrant in determining the appropriate authority. Registrants will correct self-identified deficiencies immediately. Failure to complete a self-evaluation is a deficiency.
7. Training
  7.1 In addition to training provided by the Registrant in the research facility, all personnel, students, volunteers, visiting researchers and agents applying for registration, ordering, or handling of Controlled Substances must complete Use of Controlled Substances in Research training provided by the Laboratory Safety Division prior to ordering or handling Controlled Substances. This training must be renewed annually and will be tracked by the Laboratory Safety Division.
8. Ordering and Procurement
  8.1 For Schedule I or II Controlled Substances, a DEA Registrant must either order drugs themselves or delegate an Authorized Person. The DEA Registrants must provide the Power of Attorney Form to the DEA upon request.
  8.2 For Schedule III to V Controlled Substances, a Power of Attorney is not required. However, the DEA Registrant will maintain internal documentation for whom they have delegated authority for ordering Schedule III to V Controlled Substances.
  8.3 In all cases, the DEA Registrant is responsible for supervising any person to whom they delegate the authority to purchase Controlled Substances and for periodically reviewing orders and inventory/usage.
  8.4 The DEA Registrant or the Authorized Person must collect deliveries of Controlled Substances in person at Central Receiving Warehouse.
  8.5 Controlled Substances must be purchased via Purchase Order. Credit cards may not be used for the purchase of Controlled Substances unless (1) the vendor does not accept a purchase order and (2) the Lab Safety Division has provided written approval for the individual purchase. The Laboratory Safety Division must be notified by the DEA Registrant at the time Controlled Substances are ordered.
9. Inventory and Records
  9.1 The DEA Registrant must initiate an initial inventory of all Controlled Substances when the DEA license is granted and once Controlled Substances are onsite. Registrant must maintain the inventory at the same location over the life of the Controlled Substance. Thereafter, the DEA Registrant must conduct a biennial inventory inspection on or before 24 months following the date of the initial inventory.
  9.2 The inventory records that must be maintained are the:
  9.2.1 Initial inventory,
  9.2.2 Biennial inventory, and
  9.2.3 Dispensation logs.
  9.3 DEA Registrants must store all Controlled Substance records securely and separately from general business records. Schedule I and II Controlled Substance records must be kept securely and separately from Schedule III to V Controlled Substance records.
  9.4 In addition to the required inventories, records must include:
  9.4.1 order (Form 222), receipt, and shipping records for materials in inventory, and
  9.4.2 evidence of disposition (Form 41) of the Controlled Substances.
  9.5 The DEA Registrant must keep all records for 3 years from the final disposition of the Controlled Substance unless funding agencies or UTSA policies indicate longer records retention.
10. Disposal
  10.1 The DEA Registrant is responsible for making sure that all Controlled Substances are properly disposed when:
  10.1.1 the substances expire;
  10.2.1 the Registrant’s DEA Registration is not renewed;
  10.3.1 when the Registrant no longer conducts Research at UTSA using Controlled Substances;
  10.4.1 at the conclusion of a research project involving Controlled Substances; or
  10.5.1 on termination of a grant funding Controlled Substances research.
  10.2 Under no circumstances can Controlled Substances be abandoned.
  10.3 The DEA Registrant must contact the Laboratory Safety Division to arrange for disposal of Controlled Substances and follow the disposal procedures outlined in the UTSA Controlled Substance guidelines located on the Laboratory Safety Division website.

X. SPECIAL INSTRUCTIONS FOR INITIAL IMPLEMENTATION

Prior to applying for a DEA license, all prospective DEA Registrants must abide by the requirements and responsibilities detailed in 21 CFR 9 Chapter II in addition to all UTSA policies

XI. FORMS AND TOOLS/ONLINE PROCESSES

XII. APPENDIX

None

XIII. Dates Approved/Amended

03-15-2022