4.28.7 Requisitioning and Record-Keeping of Controlled Precursor Chemicals and Apparatuses
A. Purpose
The purpose of this policy is to establish the procedures to be followed for the use of precursor chemicals and certain laboratory apparatuses at the University and to maintain compliance with the Memorandum of Understanding (MOU) between the Texas Higher Education Coordinating Board and the Texas Department of Public Safety (TxDPS).
B. Persons Affected
This Policy applies to all Employees with specific authority to purchase or accept controlled items.
C. Definitions
- MOU: Memorandum of Understanding
- Principal Investigator (PI): In research laboratories, the Principal Investigator (PI) assumes full responsibility.
- Responsible Party (RP): Any Employee with specific authority to purchase or accept controlled items.
- TxDPS: Texas Department of Public Safety
- UPD: University Police Department
D. Policy
D.1. Background
On June 4, 2020, the Texas Department of Public Safety and the Texas Higher Education Coordinating Board signed an agreement that, in accordance with Health and Safety Code, Title 6, Section 481.0621[b], establishes procedures for maintaining controlled substances, controlled substance analogs, chemical precursors, and chemical laboratory apparatuses used in educational or research activities of institutions of higher education.
D.2. Scope of Applicable Settings
This Policy applies to controlled items in basic and applied research, clinical practice, and instructional settings.
D.3. Scope of Employee Responsibilities
This Policy specifies the following Employee responsibilities:
- Personal responsibility for secure use of controlled items.
- Record-keeping requirements for purchases.
- Procedures for disposal of unused controlled items.
- Security procedures governing use of controlled items.
- A liaison between the University and TxDPS.
D.4. List of Controlled Items
Controlled items for which purchase, use, and disposal records must be kept are as follows:
Precursor Chemicals
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Laboratory Apparatuses
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Methylamine
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Erlenmeyer flasks
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Ethylamine
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Filter funnels
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D-lysergic acid
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Buchner funnels
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Ergotamine tartrate
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Separatory funnels
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Diethyl malonate
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Single neck flasks
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Malonic acid
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Round bottom flasks
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Ethyl malonate
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Florence flasks
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Barbituric acid
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Three-necked flasks
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Piperidine
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Two-necked flasks
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Phenethyl bromide
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Condensers
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Propionyl chloride
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Distilling apparatus
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Red phosphorus
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Filtering flasks
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Hypophosphorus acid
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Distilling flasks
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Phenylpropanolamine
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Thermometer flasks
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Norpseudoephedrine
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Adapter tubes
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Pseudoephedrine
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Heating mantles
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Anthranilic acid
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Flask heaters
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Ephedrine
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Transformers
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Phenylacetic acid
|
Soxhlet extractors
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Pyrrolidine
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Encapsulating machines
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Sodium borohydride
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Tableting machines
|
|
Vacuum dryers
|
D.5. Responsibility
- Scope of responsibility. The RP bears full responsibility for the procurement, safekeeping and ultimate disposal of all items covered by the MOU.
- Designation of RP.
- Research lab. If controlled items are to be used in a research lab, the PI assumes full responsibility as the RP.
- Teaching lab or class. For controlled items used in a teaching laboratory or a demonstration for a class, the Department Chair/Head is the RP.
D.6. Procurement
- Report program. The RP, with the assistance from the Department of Research Compliance, will put in place a report program to identify, highlight, and capture purchasing information on controlled items.
- Report maintenance. Copies of these reports will be maintained by the RP and Department of Research Compliance.
- Availability of reports. These reports can be obtained upon request by any state or federal agency so authorized by law.
D.7. Security
- Locations established. Specific locations where controlled items are stored or utilized should be established.
- Security of locations. All doors and windows must be locked when any room containing controlled items is not occupied.
- Unauthorized access.
- Controls established. Effective controls and procedures against unauthorized access to controlled substances must be established and maintained by each RP.
- Authorized personnel only. Access to rooms containing controlled items must be restricted to Employees authorized by the RP.
- Key control.
- Key and/or combination control must be established so that only those authorized can have access to the site.
- The Physical Plant Department can assist the RP in establishing assurance over keyed access to their assigned laboratories or storage areas.
- Proper usage. Procedures must be established by each RP to assure the proper use of controlled items in laboratories and storerooms.
- Unauthorized personnel. Employees authorized by the RP to use, handle, or store the controlled items must be alert to any unauthorized persons entering laboratories containing controlled items, and appropriate actions must be taken to assure the security of the controlled items when visitors are present.
D.8. Record-Keeping
- Inventory.
- Initial inventory. Each RP will prepare an inventory of all controlled items in their area. This inventory will be kept up-to-date and maintained for review upon request.
- Copy of initial inventory. A copy of the initial inventory will be provided to the Department of Research Compliance.
- Loss or breakage.
- Reporting. Any subsequent loss, disposal, or breakage of controlled items will immediately be reported to the Department of Research Compliance.
- Updated inventory. Updated inventories must be submitted to the Department of Research Compliance and available upon request.
- Summary. Every month a summary of all controlled items ordered, broken, or disposed of will be submitted to the Department of Research Compliance.
- Review. The Department of Research Compliance will review all purchases, breakages, and disposals of controlled items every (2) two months to determine if there has been any unusual activity.
- Unusual loss or breakage. Any unusual activity will be reported to the appropriate UPD.
- Disappearance. The RP must ensure that any unexplained disappearance of controlled items is reported immediately to the Department of Research Compliance and UPD.
- Original forms. Original forms will be retained in the Department of Research Compliance as described in Texas Administrative Code, Title 37, Chapter 13.
D.9. Disposal
- Coordination. Disposal of controlled items must be coordinated with the Department of Research Compliance and UPD.
- Donation or sale.
- Authorized individuals only. Controlled items may only be donated or sold to individuals who have the proper permit or specific authority to purchase or accept such items.
- Proof of authorization. The recipient of donated or sold controlled items will be required to provide the University with appropriate documentation of the authority to purchase controlled items using TxDPS Form RSD-904.
- Reporting. All transactions need to be reported to the TxDPS by a Chief of Police for the appropriate UPD.
D.10. Liaison
TxDPS has been informed that the Chiefs of Police for the UPDs are designated as liaisons between the TxDPS and the University. TxDPS will be notified of any changes.
E. Reference Sources and Authority