Controlled Substances Guidelines
Guidelines for the Purchase, Storage, Use, and Disposal of Controlled Substances in Research and Teaching at Texas A&M University
It is the policy of Texas A&M University to comply with state and federal law, including the Memorandum of Understanding (MOU; https://reportcenter.highered.texas.gov/agency-publication/policies-and-procedures/department-of-public-safety-dps-and-texas-higher-education-coordinating-board-thecb-controlled-substance-memorandum-of-understanding-mou/) between the Texas Department of Public Safety (DPS) and the Texas Higher Education Coordinating Board (THECB) and the Drug Enforcement Administration (DEA; https://www.deadiversion.usdoj.gov/) requirements governing the purchase, storage, use, and disposal of Controlled Substances.
Reason for Guidelines
These guidelines establish processes and controls for the purchase, storage, use, and disposal of Controlled Substances used in research and teaching at Texas A&M.
Definitions
Authorized Agent: a co-investigator, graduate student, post doc or member of laboratory staff authorized by the Registrant to access the secure storage cabinet, dispense, administer, and log Controlled Substances.
Clinical Setting: A setting where a Controlled Substance is used in a medical or veterinary application.
Controlled Substance: The current official schedule (I, II, III, IV and V) of controlled substances can be found in section 1308 of the most recent issue of Title 21 Code of Federal Regulations (CFR) Part 1300 to end (21 CFR §1308) and the final rules which were published in the Federal Register subsequent to the issuance of the CFR.
Non-Clinical Settings: A setting where a Controlled Substance is used in research, teaching or testing, which is not a clinical usage of the Controlled Substance.
Registrant: An individual who is named as the Registrant on a DEA registration (https://apps.deadiversion.usdoj.gov/webforms2/spring/main?execution=e1s1).
Effective September 1, 2016, the State of Texas no longer requires a state Controlled Substances registration or license.
Responsibilities and Processes
These guidelines do not apply to Clinical Setting activities performed at or through a Texas A&M participating pharmacy or clinic, which are governed by federal and state accrediting and regulatory agencies and are subject to review and audit by those agencies.
Investigators and teaching faculty who use Controlled Substances in the university’s Non-Clinical Settings must obtain and keep current United States Drug Enforcement Administration (DEA) registration, unless exempted by law. Registrants are responsible for procuring, maintaining security, keeping records, and disposing of Controlled Substances in accordance with federal regulations. The Registrant may not allow the permit to lapse until all Controlled Substances are spent, disposed of, or transferred to another registered person.
All faculty, staff, and students are responsible for full compliance with state and federal law and DEA regulations governing the purchase, storage, use and disposal of Controlled Substances. Registrants have ultimate responsibility for ensuring proper acquisition, use, maintenance, security, accountability and disposal of Controlled Substances.
The Division of Research (DOR) Controlled Substance Program provides guidance to employees with licensing and registration, procurement, use, recordkeeping, storage, security and disposal of Controlled Substances used in research.
Training
When checking the Controlled Substance box during grant submission, the appropriate individuals responsible for Controlled Substance compliance will be notified. Following notification, the individual requesting permission will be contacted to ensure that he/she has a DEA registration number and directed to appropriate educational material.
During periodic inspections carried out by various compliance elements, both internal and external (IACUC, IRB, USDA, DEA, etc.), registrants will be informed/trained as to the appropriate procurement, use, recordkeeping, storage, security and disposal of Controlled Substances used in research.
Purchasing Controlled Substances
Registrants who purchase and receive Schedule I and II Controlled Substances must retain DEA 222 forms, purchase orders and packing receipts for two years from the date of receipt and have them available for inspection.
Registrants who purchase and receive Schedule III-V Controlled Substances must retain purchase orders and packing receipts for two years from the date of receipt and have them available for inspection.
Storage of Controlled Substances
Storage of Controlled Substances must comply with federal requirements. Registrants are responsible for establishing and maintaining effective controls and procedures to prevent unauthorized access, theft or diversion of Controlled Substances.
Registrants are directly responsible for:
- Establishing adequate security to prevent unauthorized access to Controlled Substances.
- Establishing adequate security to prevent the diversion of Controlled Substances.
- Storing Controlled Substances listed in Schedules I-V in a secured location and in a securely locked, substantially constructed cabinet, or security cabinet (i.e., not easily broken into or moved; see 21 CFR § 1301.71-1301.76).
Reporting Theft, Unauthorized Use, or Significant Loss of Controlled Substances
The Registrant must notify the local DEA office orally within one business day after the discovery of theft or significant loss of any Controlled Substances as prescribed by 21 C.F.R. 1301.76. A written report to the DEA, using DEA Form 106 (https://www.deadiversion.usdoj.gov/21cfr_reports/theft/), must be submitted within 15 days after the discovery. The Animal Welfare Office should be notified along with the DEA when the DEA is initially notified and when the written report is sent to the DEA.
Theft or significant losses must be reported whether or not the Controlled Substances are subsequently recovered and/or the responsible parties are identified and action taken against them.
Inventory Records of Controlled Substances
The Registrant is responsible for maintaining appropriate records and inventories of all Controlled Substances where licensed activity is conducted at the university for the period of time as specified in the System Policy 61.99: Records Retention, as part of the registration requirements (21 CFR § 1304.04 and 1304.11). Complete and accurate Controlled Substance records must provide a complete audit trail, from purchase, receipt or acquisition to their dispensing or disposal and must be readily available for review by DOR compliance personnel or other authorized regulatory agencies. Registrants must maintain inventory records that include the items listed in paragraph (e)(1)(iii) of CFR § 1304.11.
Records pertaining to Controlled Substances in Schedule I and II must be maintained separately from all other records of the Registrant. Records for Schedule III, IV, and V controlled substances must be maintained either separately from all other records of the Registrant or in such form that the information required is readily retrievable from the ordinary business records (21 CFR § 1304.04).
Use of Controlled Substances
The Registrant must maintain a record of the acquisition, administration, and disposal for each Controlled Substance included on his or her inventory.
Only the Registrant and Authorized Agents may access the secure storage cabinets for Controlled Substances. The Registrant must ensure that a current list of Authorized Agents is on file.
Controlled Substances may not be sold, furnished, or transferred except as permitted by state and federal laws and regulations.
Disposal of Controlled Substances
The Registrant is responsible for the return or disposal of Controlled Substances in accordance with federal and state requirements. The Environmental Health and Safety Office can provide assistance and guidance in this area.
The Registrant must document the disposal of Controlled Substances (https://www.deadiversion.usdoj.gov/21cfr_reports/surrend/), and a copy of DEA Form 41 (https://www.deadiversion.usdoj.gov/21cfr_reports/surrend/41_form.pdf) must be maintained with the Registrant’s records to provide accountability for the disposal of these Controlled Substances.
When a Registrant leaves the university or rescinds their license, arrangements for disposal and/or transfer of all his/her Controlled Substances must be made prior to departure or license termination.
Failure to Comply
Failure to comply with federal and state requirements may result in personal, civil, and/or criminal liability. In addition, noncompliance may result in university disciplinary action and/or suspension or termination of research.
Related Statutes, Policies, or Requirements
21 U.S.C. 801, et. seq.
21 C.F.R. 1300, et. seq.
Texas Health and Safety Code Chapter 481 Texas Controlled Substances Act
Memorandum of Understanding (MOU) between the Texas Department of Public Safety (DPS) and the Texas Higher Education Coordinating Board (THECB) https://reportcenter.highered.texas.gov/agency-publication/policies-and-procedures/department-of-public-safety-dps-and-texas-higher-education-coordinating-board-thecb-controlled-substance-memorandum-of-understanding-mou/
System Policy 61.99: Records Retention