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Controlled Substances

Office of the Vice President for Research

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Council of Research Associate Deans

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Human Research Protection Program

If you have questions after reviewing this web site and the instruction documents provided here, contact Kathy Fox at foxxx005@umn.edu or 612-624-0664.

Employees who work with controlled substances for research are strongly recommended to complete the online tutorial: Using Controlled Substances for Research. It provides an introduction to Federal and State regulations, and University policy and procedures about the use of controlled substances for research. After taking the tutorial, the record will be posted in the employee's online training record.

Registrations

To use controlled substances for research and teaching at the University of Minnesota, state and federal registrations are required. These documents will provide the guidance to obtain the registrations you need.

All changes of Unit and Location Registrants, including additions to the Unit, must be reported to Kathy Fox.

• Applying Online for DEA Registration

• Changing DEA Research Registrant
  

• Changing Location Registrants and Locations in Your Unit
• Closing a Lab with Controlled Substances
• Exemption to Registration Structure
  • Applying for an Exemption
• New to Using Controlled Substances for Research
• Mandatory DEA-related Questionnaire
  
• Minnesota Board of Pharmacy Applications for Researchers
  
• Unit and Location Registrant’s Roles and Responsibilities

Purchasing and Security

Purchasing Controlled Substances

The use of centralized purchasing of controlled substances is highly recommended. On the Minneapolis campus, Boynton Pharmacy will obtain, and often stocks, the controlled substances commonly used in animal research. In St. Paul, the Veterinary Medical Center Pharmacy can supply most controlled drugs.

• Boynton Memo to Researchers
• Purchasing Requirements for VMC Pharmacy
• Using DEA Form 222 to Order Controlled Substances
  

Security

The University of Minnesota policy Using Controlled Substances for Research requires researchers to store controlled substances in a safe. Small safes must be bolted to an immovable object.

• Guidance for Purchasing a Safe to Store Controlled Substances

Inventory and Record-keeping

The following forms and records have been created to meet the record-keeping requirements for using controlled substances for research. They contain all the required elements in the DEA regulations.

• Authorized Users Signature Log
  
• Controlled Substance Disposal Form
  
• Combined Drug Disposition Record

• Research Controlled Substance Inventory
  
• Research Controlled Substance Disposition Record
  
• Single Drug Disposition Record
  

Forms and Instructions

There are three DEA forms that may be needed by researchers using controlled substances.

• DEA Form 106: Reporting Theft or Loss of Controlled Substances
  Instruction Document: Reporting Theft and Loss on DEA Form 106
  When to Use Form 106
  
• DEA Form 41
  Instruction Document: Reporting Accidental Loss on DEA Form 41
  
• Power of Attorney Form
  Using DEA Power of Attorney Form
  

Standard Operating Procedure (SOP)

The University of Minnesota Controlled Substances SOP defines the person who is responsible for each of the activities related to using controlled substances for research.

• SOP: Using Controlled Substances for Research

Policy and Procedures

• University of Minnesota policy Using Controlled Substances for Research
  • Purchasing, Receiving and Storing Controlled Substances
  • Using and Disposing of Controlled Substance