When the decision is made to obtain a DEA registration the individual seeking the registration needs to plan his/her research timeline accordingly keeping in mind that process for obtaining a registration number may take 4 to 8 weeks from the time the application is submitted to the DEA. Part of the application process will include a site visit from the local DEA office to ensure that adequate security measures have been put in place to prevent the loss of controlled substances once acquired by the researcher.
If you are applying for a researcher registration,you will need to fill out a DEA form 225 initially and then a DEA form 225a every time there after to renew the DEA registration.
If you are applying for a practitioner registration, you will need to fill out a DEA form 224 initially and then a DEA form 224a every time there after to renew the DEA registration.
Application tip 1: In section 4 of the 225 application, the State License Number only applies to you if you have a license to prescribe pharmaceuticals. If you do not have this license, leave the first entry blank. In addition, the state of Colorado does not issue State Controlled Substance Licenses so the second entry in section 4 needs to be left blank.
Application tip 2: In section 6 of the 225 application, if you are a UCD researcher you are exempt from having to pay the application fee. As such, you need to do the following to receive this exemption: 1) check the box to claim the exemption and 2) enter the contact information for the dean of your department.
Once you obtain your DEA license, you must register with UCD's Reverse Distributor Program, by emailing a copy of the registration to EHS — ATTN: Reverse Distributor Program.
Specific security guidelines are codified in 21 CFR 1201.71. Per guidance given from our local DEA office so long as each researcher has an individual cabinet, solely for his/her storage that is not transportable (i.e. small two drawer cabinets should be bolted to the desk), which can be locked, chances are that will meet the security requirements. In addition, the cabinet should be "substantially constructed" which would exclude any storage cabinets with glass doors. The determination of whether a researcher has met the intent of the security requirements rests solely on the interpretation of the DEA Diversion Investigator when the pre-registration investigation is conducted.
Controlled substances must be stored at the address on the registration. If research involving the controlled substances needs to be conducted at a different location from that listed on the registration, the researcher or his/her agent can transport the controlled substances to the off-site location so long as it is done within the scope of their employment. This does not authorize an agent or registrant who is off duty, going home, etc., to be in possession of the controlled substance. Lastly, the controlled substances must be returned to and secured at the registered location at the end of the day.
In order to make sure that controlled substances aren 't lost, stolen, or misused, an active inventory must be maintained. This is as important as the physical security measures taken to ensure the proper management of controlled substances.
A registered practitioner/researcher needs to ensure that the following types of inventories are kept and made available during an inspection:
An initial inventory according to 1304.11(b).
The subsequent biennial inventories according to 1304.11(c).
Ongoing use logs according to 1304.22(c) For the ongoing log you can simply download a sample template from the forms section DEAInventoryLog-HWF-015.pdf of the EHS website to use for controlled substances on any of the schedules. Use of this particular inventory log is not required; it is simply made available by EHS in an attempt to simplify your recordkeeping responsibilities.
In the course of an audit or during your general housekeeping routine in your lab, you might come across controlled substances that might have been left behind by a member of your lab who is no longer part of the institution. If this is ever the case, the controlled substances in question are considered to be abandoned and you are considered to be in illegal possession of controlled substances. To legally dispose of these controlled substances see the section below dealing with disposal of controlled substances.
When there is no longer a legitimate use or need for a controlled substance on your DEA registration or if you are in possession of abandoned controlled substances, DO NOT dispose of these materials by dumping them down the sink. This is an unlawful practice that is now prohibited by the DEA and department of health. Instead, contact the Hazardous Materials Reverse Distributor Group (303-724-0344 or 303-724-0345) to have your unwanted controlled substances disposed of in a proper and legal manner.
Upon destruction of your controlled substances you will be mailed copies of the destruction paperwork for you to keep as proof of destruction. If you do not receive the destruction documentation within 14 days please contact the Reverse Distributor group.
Any loss, theft, or diversion of any kind related to controlled substances under your registration need to be reported immediately and without delay to the local DEA field office (720-985-4233). Additional notification needs to be given to the University Police Department (303-724-4444) so that a formal investigation can be started. In addition, DEA Form 106: Theft or Loss of Controlled Substances need to be filled out on line and submitted to the DEA. Keep in mind that only those persons registered with and authorized by the DEA to handle controlled substances may utilize/submit this form.
When preparing to leave the university it is the researcher's responsibility to ensure that a new DEA registration at their new site is applied for and approved before removing any controlled substances from the university. If research at the new location will no longer require the use of controlled substances either of the following two steps can be done to remove the controlled substances from the researcher's DEA registration:
Transfer the controlled substances to another researcher or,
Turn in the controlled substances to the reverse distributor group for destruction.