Policies & Guidelines
Prior Approval
All research and/or teaching activities involving the use of controlled substances must have prior written approval from the appropriate campus regulatory bodies.
The approving bodies are typically the Boulder Institutional Animal Care and Use Committee (IAC) or Institutional Review Board (IRB). Once the research/teaching activity has been approved, the DEA registrant shall purchase controlled substances from licensed vendors using his/her own registration number.
The registrant shall not purchase controlled substances for other personnel, or for use in other activities that have not received prior approval.
All personnel who work closely with controlled substances in your lab are subject to a criminal background check to determine if they have ever been convicted of a drug-related offense, or a felony of any sort. If any of your personnel make such a disclosure, you are required to contact your local DEA field agent in order to determine if personnel participation in your activities involving controlled substances is allowable. More information about the process of conducting background checks can be found in the campus policy , or by contacting either Ingrid Arran or Trent Delong in HR.
Use/Disposition Records
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The registrant must carefully and thoroughly document all actions taken with the controlled substance, which includes receiving, using, diluting/combining, transferring or disposing of expired and waste controlled substances. Record the use of controlled substances on disposition records; a recommended disposition record form is available on the Forms section of this website. Use records must be maintained in a way that clearly reflects when, and how much of a particular controlled substance was introduced into a registrant’s laboratory. Once a controlled substance is introduced into a registrant’s laboratory, the specific dates and times of use, as well as the identity of the personnel who used the controlled substance, must be clearly documented at the time of use (retrospective record keeping is not allowable). It is critical that records be kept so that the amounts of controlled substance used in research can be clearly reconciled with the amounts of controlled substances that were acquired by a registrant.
Labeling
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If controlled substances are removed from their original packaging and compounded, diluted or combined, each new container must be labeled and tracked. The label must include:
- the name of the controlled substances,
- the lot number, the final concentration,
- the amount per container, and
- the expiration date.
Inventory
Once a license is acquired, it is critical that an initial inventory is conducted and recorded so that the use of controlled substances can be accounted for from the time of their acquisition. Record keeping must be conducted in such a way that a quantitative history of controlled substance use in research can credibly and easily account for drug use. Every two years, registered users must complete an inventory to compare the actual count of controlled substances to the amount in the written disposition records. A recommended inventory form is available on the Forms section of this website. More frequent inventories are recommended for laboratories using schedule II drugs, higher volumes, multiple controlled substances or those labs with many authorized users.
Storage and Security and Order Forms
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Controlled substances and order forms must be stored in a sturdily constructed, locked cabinet separate from other drugs or materials. In general, DEA regulations call for the storage of controlled substances and order forms in the same venue. If a registrant should choose to store order forms in a separate place for the sake of enhanced security, he/she must receive prior approval from the (1-800-326-6900).
Disposal
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Controlled substances that are outdated, surplus, or contaminated must be disposed of according to federal regulations and DEA policy. Disposal of controlled substances must be effected through the use of a “reverse distributor.” A “reverse distributor” is a DEA registered entity that is legally allowed to handle controlled substance disposal. The System has established a reverse distributorship for the disposal of controlled substances. On the Boulder campus, disposal is handled by the Department of Environmental Health & Safety; the point of contact for the disposal of controlled substances is Cher Masini, the Biosafety Officer. Depending on the origins of the controlled substances (e.g. expired with a current license, ‘spent’ materials, materials abandoned without a known registrant, etc.), different types of paperwork may be required to initiate and complete the disposal process. The Hazardous Materials Program Manager will be able to provide guidance in this regard.
Reporting Theft or Loss
If you suspect a theft, immediately notify the Police Department (303-492-6666) and the local DEA Field Office (720-895-4040). In addition, the DEA requires that theft or loss of controlled substances be reported on .
If a container of a controlled substance is inadvertently broken or damaged, document this in the disposition record and have a witness sign and date it, if possible. Complete a for the amount of the substance lost and write “unintentional destruction” on the form. Signatures of the person who broke the bottle, the witness and the Registrant are required on Form 41. Mail the original to the DEA and file a copy with your controlled substance records.
Retaining Records
Controlled substance records must be maintained for at least 2 years.
Other
An overview training was held virtually on November 5th, 2021; the slides from that presentation are available here. Questions regarding the use of Controlled Substances in animal research should be directed to the IAC Director, Althea Lantron. For inquiries regarding the use of Controlled Substances in human research, contact Dr. Claire Dunne. If you have other questions, contact Tom Heddleston, Regulatory Compliance Associate (303-492-0770).