Printed on: 11/11/2025. Please go to policy.umn.edu for the most current version of the document.
University of Minnesota  Administrative Policy

Controlled Substances Management

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Policy Statement

In conducting activities with controlled substances, University employees and any other individuals using University resources or facilities, or receiving funds administered by the University, and volunteers and representatives who may speak or act as agents for the University, must comply with this policy and federal and state regulations relating to controlled substances.

Individuals who fail to comply with this policy may be subject to discipline, referral for research misconduct proceedings, and/or reporting to external licensing authorities by the University. Any disciplinary action imposed will follow the applicable Board of Regents and administrative policies and procedures for the individual's employment.

Controlled Substances Compliance Management and Responsibility

The Executive Vice President for Finance and Operations is responsible for administering this policy and has the authority to enforce practices and stop any activities deemed unsafe or non-compliant with applicable State or federal regulations at the University. The Assistant Vice President for Health, Safety and Risk Management or their designees will assist the Executive Vice President for Finance and Operations with administering health and safety policies and programs at the University.

Health, Safety, and Risk Management

Health, Safety, and Risk Management (HSRM) is responsible for providing leadership, resources, and services to ensure that applicable regulations, policies, and procedures are being implemented, and compliance is met. The Controlled Substances program must be followed by all University staff if applicable to the type of work being performed:

See Controlled Substances Use at University

HSRM is also responsible for representing the University during regulatory inspections and acts as the liaison between the regulated department/activity and the regulatory agency.  

Reason for Policy

This policy supports the numerous State and federal government regulations pertaining to the legal purchase and use of controlled substances. University employees and other individuals covered by this policy must comply with this policy in order to ensure that they follow all applicable regulations and safely handle and prevent diversion of controlled substances.

Procedures

There are no procedures associated with this policy.

Forms/Instructions

Forms and Instructions can be found on the HSRM website

Controlled Substances Use at University

Appendices

There are no appendices associated with this policy.

Frequently Asked Questions

There are no FAQs associated with this policy.

Contacts

SubjectContactPhoneEmail
Primary ContactSabine Fritz612-625-7227[email protected]
Responsible Individuals
Responsible Officer Policy Owner Primary Contact
  • Associate Vice President for Health, Safety, and Risk Management
  • Associate Vice President for Health, Safety, and Risk Management
  • Sabine Fritz

Definitions

Authorized User

A University employee authorized to access controlled substances by a DEA Registrant.

Clinical Setting

Environment where healthcare services are provided.

Controlled Substance

Any substance listed in the Controlled Substances Act, Code of Federal Regulations (21 CFR, part 1300 to end) Minnesota Statute 152.01-.02 or Minnesota Board of Pharmacy Rules, Chapter 6800.4210 to 6800.4250.

DEA Registrant

A University employee delegated by the department head to hold DEA registration and is responsible for ordering, storing, using and disposing of controlled substances.

Designee

A University employee delegated by the DEA registrant to assist laboratories in ordering, storing, and disposing of controlled substances.

Disposal

The action of getting rid of expired, excess and unwanted controlled substances. Disposal also refers to controlled substances that are residual (often referred to as waste) or have been contaminated through use.

Disposition Records or Perpetual Inventory

An accurate, continuous and current record used to track the acquisition, use and disposal of controlled substances. These are not the same as lab books a researcher uses to record scientific findings.

Drug Enforcement Administration (DEA)

The agency within the United States Department of Justice that enforces the controlled substances laws and regulations.

Minnesota Board of Pharmacy (MNBP)

The agency authorized by the state of Minnesota to implement and regulate Minnesota Statutes and Board of Pharmacy Rules and to oversee the conduct and professional competence of MNBP registrants.

Registration

Formal grant of specific authority by the DEA.

Research

Systematic investigation, including development, testing and evaluation designed to develop or contribute to general knowledge.

Responsibilities

Authorized Users

Complete the online tutorial. Properly use controlled substances and maintain disposition records; perform activities with controlled substances as directed by the DEA Registrant, sign Authorized Users Signature Log, perform DEA required inventories and report significant volume discrepancies to the DEA registrant.

Health, Safety and Risk Management (HSRM)

Perform periodic site reviews which include reviews of Registrant's purchasing and disposition processes as well as inventory records and security measures; verify registration and justification for use; maintain recommended Controlled Substances tutorial regarding policies and procedures for registrants and authorized users; provide guidance and support to researchers and clinicians; approves use of controlled substances in animal usage protocols for IACUC. Perform controlled substances audits of DEA registrants’ laboratories and clinical spaces.

HSRM holds DEA Schedule I-IV registrations for Thompson Center allowing for pickup of controlled substances for disposal according to policy and regulations. Periodically review security and compliance procedures of controlled substance storage facilities.

Department Head

Designate and support the DEA Registrant.

DEA Registrant

Maintain DEA registration. Exercise signature authority to purchase and dispose of controlled substances used within that Unit. Able to designate Power of Attorney for ordering Schedule I and II substances. Ensure proper use, storage and disposal of controlled substances and maintenance of disposition records at each location. Conduct University required annual audits comparing disposition records to safe content, noting all discrepancies. Ensure that HSRM is informed and included in all discussions and meetings with the DEA and the Minnesota Board of Pharmacy. Report inventory discrepancies to HSRM. Report significant inventory discrepancies as required by the DEA and MNBP administrative rules 6800.4800.

Designee

Duties as assigned by the DEA registrant.

Related Information

Related Policies

Other Related Information

History

Amended:

September 2025 - Comprehensive Review.

Included clinical laboratories under the policy's coverage. Removed responsibilities previously assigned to Registrants and Authorized Users. Eliminated exclusions section. Introduced a new section on Controlled Substances Compliance Management and Responsibilities. Relocated the Health, Safety, and Risk Management content from Procedures to a standalone section to better emphasize their role. Removed Forms and Instructions section; users are now directed to the Controlled Substances website for relevant resources.

University has an administrative policy for the use of controlled substances in research settings but does not currently have a policy that covers the use of controlled substances in clinical settings. To address this inconsistency, the Office of Institutional Compliance (OIC) partnered with Health, Safety, and Risk Management (HSRM) to conduct a risk assessment to determine if any compliance gaps exist that needed to be addressed in clinical settings.

Amended:

January 2022- Comprehensive Review.

  1. Eliminates the DEA Questionnaire by adding the questions to the authorized user signature log.
  2. Separated audit responsibilities into University required annual audit and DEA required biennial inventory. Clarified who is responsible for the annual audit vs. the DEA biennial inventory.
  3. Changed record retention from 3 to 2 years.

Amended:

August 2016 - Comprehensive Review, Eliminates the requirement to send an annual inventory to UHS. Changed the order of the wording in the Policy Statement. Spelled out the duties of the Registrant and the Authorized User in the Policy Statement. Added more details to the Responsibilities section for UHS.

Amended:

May 2013 - Updated to reflect program move from Research to University Services.

Amended:

July 2012 - Comprehensive Review, Major Revision - 1. Eliminates the requirement to register with the Board of Pharmacy, which supports the risk recalibration initiative. 2. Removes a requirement to have a location registrant in each research lab using controlled substances.

Amended:

January 2006 - Simplified the DEA registration process. Corrected the controlled substances disposal process. Clarified responsibilities between ORA and DEA. Changed procedure titles, and reformatted and updated the information.

Amended:

June 2001 - Updated definition of "Disposal" and responsibility for "unit registrant", and procedures were updated to reflect the updated disposal and unit registrant definitions and to make sure these were consistent with Drug Enforcement Agency (DEA) and Minnesota Board of Pharmacy regulations. These updates were approved by the Faculty Consultative Committee.

Amended:

August 2000 - Updated January 2000 revision history entry. Changed "While department licenses will have a designated person, the department and University assume liability for the license rather than the individual". to the following: "A designated person will hold the DEA and MNBP licenses in the name of the University Unit." Since the Unit Registrant does still hold some personal responsibility as the DEA and MNBP registrant, the entry in the revision history was changed to reflect this.

Amended:

January 2000 - Revised to centralize control and oversight for controlled substance licensing and auditing; Individual DEA licenses are replaced in favor of two-tiered system to license departments or units and individual laboratories; A designated person will hold the DEA and MNBP licenses in the name of the University Unit; Departments will be responsible for serving as a gatekeeper for controlled substances purchases and determining the validity of requests; The Office of Regulatory Affairs can assist in this by providing evidence of IRB or IACUC approval for use of controlled substances in human or animal subjects; A system for monitoring purchases will be developed; The Department of Environmental Health and Safety and Office of Regulatory Affairs will share responsibility for policy implementation; Annual self-audits by license holders and reviews by DEHS and RA will be performed; Policy Statement, Reason, Definitions and Responsibilities sections rewritten and clarified. Procedures rewritten to reflect the changes described above. Added forms section.

Effective:

July 1997