Unit Responsibilities

Unit Registrants Roles, Responsibilities, and Registrations

The Unit Registrant is the DEA registrant for research in a particular Unit (department or other University administrative unit).

The Unit Registrant

  • Is appointed by the unit administrator
  • Holds a Drug Enforcement Administration (DEA) registration for the unit
  • Exercises signature authority for purchases and disposal of controlled substances
  • Conducts or receives annual inventory record from all locations
  • Reports inventory theft or loss to the DEA and MNBP

Please familiarize yourself with the instruction documents and other guidance that is available on the Controlled Substance web page. All the instructions, documents, and hyperlinks referenced in this document are available on that site.

Authorized Users perform one or more activities (receiving, using, disposing, etc.) with controlled substances for research under the supervison of the Unit Registrant or lab manager.

Authorized Users

  • Complete the controlled substances training module and receive lab-specific training in procedures for using controlled substances
  • Before being allowed to work with controlled substances for research, all Authorized Users must sign the DEA-related questionnaire
  • Sign Authorized Users Signature Log
  • Do not need any specific registration

Standard Operating Procedure

Controlled substances must be properly handled at all stages of purchase, use, storage, etc. The Controlled Substances Standard Operating Procedure (SOP) has been created to serve as a reference in the laboratory. The SOP defines the responsible person for each of the activities related to using controlled substances for research.

Registrations

A Drug Enforcement Administration (DEA) registration is required for using controlled substances for research and teaching in each Unit.

The DEA issues registrations specifically for possession and use of controlled substances for research. A DEA registration for research is separate from a DEA registration for clinical use. The DEA online application for research registration is DEA Form 225. Research DEA registrations are issued for one year and must be renewed online annually. The DEA does not charge the University of Minnesota for research registrations.

Controlled substances used exclusively for teaching activities require the DEA Form 224 registration, which is valid for three years. There is no charge to the University for Form 224 registration used for teaching.

At the University of Minnesota, the DEA research and teaching registrations are held in the University Unit's name (usually the department or division name) and then the Unit Registrant's name. This allow the University to easily change the Unit Registrant's name. The DEA online application instructions  will guide you through correctly completing the online DEA application.

To change the Unit Registrant, it is not necessary for the new Unit Registrant to start with a new DEA application. The current Unit Registrant sends a letter to the DEA requesting the name change. For more information about this process, please see Changing Research DEA Registrant.

All changes of Unit Registrants must be reported to DEHS.

Unit and Registration Structure

The department head or unit administrator appoints a Unit Registrant for the Unit. Each Unit laboratory using controlled substances for research or teaching must have the approval of the Unit (DEA) Registrant.

The Unit Registrant obtains a DEA registration for each University building address where controlled substances will be stored in the Unit.

For example, if a Unit has three separate laboratories in two different buildings where controlled substances are stored and used, the Unit Registrant would be required to have the following:

  • 2 DEA registrations

Many departments, divisions, or other University administrative units have a Unit Registrant already established. New researchers within the Unit should check with their administrator to find out the name of the Unit Registrant and if there is a DEA registration for the building in which their new laboratory is located. If a DEA research registration exists in their Unit for the building in which their lab is located, the new researcher must contact the Unit Registrant to inform him or her that the lab will be using controlled substances for research. If no DEA registration exists for their building, the Unit Registrant must apply for the research DEA registration at that building address. 

The DEA requires a separate research DEA certificate for C-I controlled substances. To comply with the DEA regulations, C-I drugs must be stored in a safe separate from other scheduled drugs. The C-I safe must have access limited to the Unit Registrant. 

Power of Attorney

If the Unit Registrant will not be available for a specific period, the Power of Attorney Form may be used to assign signature authority to another person to order controlled substances for research activities. The Power of Attorney is assigned only for the specific period of time the Unit Registrant is absent and is not assigned as an enduring power of attorney.

Link:
Power of Attorney Form