The DEA says that I need to double-lock my controlled substances. What does this mean?
This means that two locks must be in place to adequately secure the controlled substances. A laboratory door that is locked when authorized personnel (the licensed researcher, authorized agent(s) of the licensed researcher, or authorized lab personnel) are absent can serve as one of the “locks.” Within the laboratory, controlled substances must be secured within a locked cabinet or safe that cannot be moved or transported.
- Schedule I and schedule II controlled substances must be secured within a specific type of safe or steel cabinet. The DEA regulations provide specifications regarding such enclosures.
- A narcotics cabinet (double lock, double door, which must be bolted to a wall) is recommended for drug storage. The safe or cabinet must remain locked at all times when controlled substances are not being dispensed from or returned to storage. Details regarding security requirements can be found in 21CFR Section 1301.7.
Please discuss with the IBPE representative (see IBPE contact information), prior to installing a safe or cabinet for storing the controlled substances. The University’s Work Control Center can help you install a locked cabinet or safe that is required to be bolted in a secured fashion.
Is there a supplier of double lock storage cabinets for controlled substances?
You can find standard “narcotic cabinets” through Health Care Logistics Inc.
Please be aware that DEA regulations require that the cabinet be secured. DEA regional representatives will visit your lab as part of registration to ensure that the cabinet is bolted to the wall and that the interior double lock compartment is bolted to the main cabinet.
Can I charge the purchase of a new safe to my grant?
Yes. The costs of securing the controlled substance in a secured cabinet or lockbox could vary substantially between labs. Please contact the Office of Sponsored Programs to address this issue on a case-by-case basis. Contact the University’s Work Control Center for scheduling someone to secure a cabinet in your laboratory.
How do I store controlled substances?
Controlled substances must be stored securely. Controlled substances should be separated from other drugs or other hazardous chemicals. This practice will help to prevent loss by limiting access to only those who are assigned to work specifically with controlled substances. It is recommended that access be limited to a minimum number of approved personnel as possible. When in use, controlled substances should never be left unattended. Please review the DEA requirements.
How do I store controlled substances during field work?
Controlled substances must be stored in a locked box either under direct control of an authorized agent or authorized lab personnel or in a locked building or vehicle when not in use during field work. An example of field work could be when the authorized work is performed in a fume hood located in a different room within the building or in an animal research area on a different floor of the same building.
My colleague and I have separate DEA registrations in a shared laboratory. Can I share the drug locker of my colleague in the department?
No. Each licensed researcher should maintain her or his own secured lockbox or other secured cabinet for storage of DEA-controlled substances that are permitted by the individual license.
How do I report if I discover a loss or theft?
Authorized personnel are expected to report missing controlled substances to their supervisor, and the University of Iowa Public Safety Office as soon as the loss is discovered. Public safety and law enforcement officials will investigate the diversion, loss, or theft of controlled substances. If any imminent safety threat exists, contact Public Safety directly at 911.
In addition, upon discovery of the theft of significant loss of any controlled substance, licensed researchers must notify the DEA field office in Des Moines and complete DEA form 106 documenting the loss or theft.
I suspect that controlled substances have been stolen from the lab, but since I am not the licensed researcher or an authorized agent I can’t be sure. What should I do?
The licensed researcher is ultimately responsible for the oversight of controlled substances that are maintained or used under her/his direction. Hence, any suspicion of possible diversion of a controlled substance should be initially brought to the attention of the licensed researcher, who must promptly report suspicion of drug loss or theft to the attention of the UI Public Safety office and to the DEA Field Office (515-284-4700 or ext. 4709). Notification to the DEA should include the licensed researcher promptly completing a DEA form 106.
What are the consequences of engaging in illicit activities?
It is the position of the DEA that employees who possess, sell, use or divert controlled substances will subject themselves not only to a State or Federal prosecution for any illicit activity, but shall also immediately become subject of independent action by the University regarding their continued employment. The University will assess the violation and determine whether to suspend, transfer, terminate or take other action against the employee.
What are the fines and penalties if I am non-compliant with either the IBPE or the DEA controlled substance regulations?
Actions may include administrative, civil, or criminal prosecution. The DEA can fine a licensed researcher for each and every violation that it finds. Loss or suspension of a controlled substance license and DEA registration could be catastrophic for a research investigator.
What is the definition of ‘access to controlled substances’?
Anyone who has the ability to access or can gain access to controlled substances: a person who is responsible for (1) obtaining, assuring secure storage, managing the initial or annual inventory, (2) completing the aliquot logs and recordkeeping, (3) distributing controlled substances or a dilution thereof to other approved laboratory personnel, and (4) dispensing to an animal or disposing of controlled substances waste.
What are acceptable storage and security practices?
Regardless of the source of the controlled substance, materials must be securely locked. A two key security system must be in place. Existing casework may be sufficient to limit inappropriate access if a cabinet or drawer is locked in a non-glass cabinet or drawer integral to the casework. Controlled substances must be accessible only to those who passed the background check by the DEA and their authorized personnel and are used only for legitimate research purposes. Order and store only the minimum amount of controlled substances necessary for planned experiments.
As a new DEA registrant, when can I expect a DEA inspector to visit my research lab for approval of my secure storage?
For new applicants, a Des Moines DEA investigator will contact you and send a list of items that you will need prior to an on-site inspection. Typically, turnaround time for this is 6-8 weeks.