This webpage was developed by UCD EHS and is intended to provide general guidance for any researcher on campus whose research involves the use of controlled substances.
Complete details and specific requirements mentioned in this site are explained in detail in Title 21 of the Code of Federal Regulations.
Any further questions about the registration process can be addressed by calling the DEA's Registration Support number (800) 882-9539.
Controlled substances are any drugs or chemical substances whose possession and use are regulated under the United States Controlled Substances Act. Controlled substances exhibit stimulant, depressive, and/or hallucinogenic effects on individuals who consume them and tend to promote abuse and psychological/physical dependence. For a complete listing of controlled substances visit the DEA web site. Management criteria differ depending on which controlled substances "schedule" the chemical is listed under.
Before any controlled substance can be purchased a researcher, a valid DEA registration number must be obtained from the local DEA office and that number must be subsequently registered with the university's reverse distributor program.
Some states require that you register with them before applying for a controlled substances license through the DEA. Colorado does not require you to register with the state. NOTE: Starting July 1, 2009: Researchers that were previously obtaining their controlled substances from the Vivarium will no longer be able to do so unless they have their own DEA controlled substances registration. For more information on this subject read the document Investigator Use of Controlled Substances in Animal Care and Use Protocols and DEA License Acquisition.
Registration Types
- Registration Process
- Security
- Recordkeeping
- Abandoned Controlled Substances
- Disposal
- Lost or Stolen Controlled Substances
The first step in applying for a DEA registration number is determining what type of registration is needed. The two most common types of registrations used by the UCD research community are "Practitioner" or "Researcher" registration. The Practitioner registration can only be applied for by a physician, is good for three years, and carries with it a larger registration fee. The Researcher registration can be applied for by a non-physician and is good for one year. The fee for a Researcher can be waived when the license is obtained for work at UCD (during online registration you will be asked to provide an institution representative's name for verification of fee waiver. Use your department dean or the vice chancellor for research, who can verify you are an employee of UCD, a state institution). The table below summarizes and compares the two types of registrations.
Drug Enforcement Administration (DEA) Registration Process
| Business activity |
Controlled substances |
DEA application forms |
Registration period (years) |
Coincident activities allowed |
| Practitioner |
Schedules II-V |
New
— 224
Renewal
— 224a |
3 |
May conduct research and instructional activities with those substances granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. Need to be a registered physician. |
| Research |
Schedule I |
New
— 225
Renewal
— 225a |
1 |
A researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in Sec. 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances. Need not be a physician. |
| Research |
Schedules II-V |
New
— 225
Renewal
— 225a |
1 |
May conduct chemical analysis with controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities or research with such substances, and to persons exempted from registration pursuant to Sec. 1301.24; and conduct instructional activities with controlled substances. Need not be a physician. |
NOTE: For the purpose of applying for a DEA registration, an applicant's legal status (green card, student visa, legal resident, etc.) is not an issue of concern so long as the applicant is able to provide references/past history on any research they have done.
Registration Process
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, a sample of the actual DEA-225 application can be printed out and filled out ahead of time. Filling out the application ahead of time will ensure that all of the required information is available before starting the online application process. If you are applying for a practitioner registration, a paper DEA-224 application can be requested in writing from the DEA at the following address:
Drug Enforcement Administration
Attn: ODR P.O. Box 2639 Springfield, VA 22152-2639
Application is conducted with DEA at:www.deadiversion.usdoj.gov/online_forms.htm.
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 sending a copy of the license via fax (303-724-0388) or email to the Environmental Health and Safety Department (EHS) — ATTN: Reverse Distributor Program.
Security
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.
Recordkeeping
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.
Abandoned Controlled Substances
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.
Disposal
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.
Lost or Stolen Controlled Substances
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.
Leaving the University
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.
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