In conducting research and teaching 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.
Failure to comply with this policy may be grounds for discipline by the University, suspension or termination of research by the University Institutional Review Board or Institutional Animal Care and Use Committee, referral for academic misconduct proceedings and/or reporting to external licensing authorities. Any disciplinary action taken by the University will follow the employment rules governing the individual's employment category.
Exclusions
This policy does not apply to controlled substances dispensed by a practitioner to a patient in the course of professional practice as authorized by his/her license.
This policy does not cover teaching activity performed within a clinical environment. However, clinical teaching activities must still comply with DEA and MNBP regulations applicable to practitioners and pharmacies.
The state and federal governments have numerous 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.
More Controlled Substance forms are listed at the Department of Environmental Health and Safety website.
- Authorized Personnel
- A University employee authorized to use controlled substances by a Location or Unit Registrant who also serves as his/her direct supervisor.
- Controlled Substance
- Any substance listed in the Controlled Substances Act, Code of Federal or Substance Regulations (21 CFR, part 1300 to end) Minnesota Statute 152.01-.02 and Minnesota Board of Pharmacy, Chapter 6800. 4210 to 6800.4250.
- Department of Environmental Health and Safety (DEHS)
- The University of Minnesota Department of Environmental Health and Safety
- Disposal
- Disposal of controlled substances that are outdated, excess or no longer intended for use. Disposal also refers controlled substances that are residual (often referred to as waste) or have been contaminated through use.
- Disposition Records
- An accurate, continuous and current record used to track the acquisition, use and disposal of controlled substances.
- Drug Enforcement Administration (DEA)
- The unit within the United States Department of Justice that establishes and enforces regulations for the handling and use of controlled substances.
- Institutional Animal Care and Use Committee (IACUC)
- The Institutional Animal Care and Use Committee for animal subjects use managed by the Research Subjects Protection Program (RSPP) in the Office of the Vice-President for Research
- Institutional Review Board (IRB)
- The Institutional Review Board for human subjects use managed by the Research Subjects Protection Program (RSPP) in the Office of the Vice-President for Research
- Licensed Practitioner
- A physician, dentist, veterinarian, or other individual licensed, registered or otherwise permitted by the United States or the jurisdiction in which they practice, to dispense a controlled substance in the course of professional practice.
- Location
- A room or designated area where controlled substances are stored or used. A location is managed by a single University employee, has a single address and is designated by a Unit Registrant to serve as a single MNBP registration site.
- Location Registrant
- A University employee authorized by his/her Unit Registrant and is responsible for compliance with regulations and University procedures at the location.
- Minnesota Board of Pharmacy (MNBP)
- The agency authorized by Minnesota statute that requires any person who engages in research, teaching or educational projects involving the use, study or testing of controlled substances, to apply annually for registration.
- Registration
- Formal grant of specific authority by the DEA and/or Minnesota Board of Pharmacy (MNBP)
- Regulatory Affairs (ORA)
- The Office of Regulatory Affairs in the Office of the Vice-President for Research is responsible for ensuring compliance of University of Minnesota personnel with internal policies and procedures and with local, State and Federal regulations.
- Research
- Any investigative activity engaged in by University personnel using University facilities or resources regardless of funding source.
- Teaching
- Teaching activities include classroom demonstrations, laboratory exercises and research projects that are required for completion of a course at the undergraduate, graduate or professional level.
- Unit
- A Unit is a department or other administrative structure which is designated by ORA for the purposes of this policy.
- Unit Registrant
- A University employee delegated by his/her department head to hold DEA and MNBP registrations in the name of the Unit and is responsible for ordering, storing, using and disposing of controlled substances.
- Authorized Users
- Properly use controlled substances and maintain disposition records. Allowed to perform activities with controlled substances as directed by Location Registrant. Must sign Authorized Users Signature Log.
- Department of Environmental Health and Safety
- Maintain a current list of all registration holders. Approve and periodically review security of controlled substances storage facilities. Assist review and approval of exemptions.
- Department/Unit Head
- Designate the Unit Registrant for the unit and sign exemption form.
- Location Registrant
- Maintain a MNBP registration. Accountable for use of controlled substances at that location. Properly store and use controlled substances, and maintain appropriate disposition records. Supervise use by authorized users. Conduct annual inventory of controlled substances. Notify Unit Registrant of discrepancies found in the inventory.
- Office of Regulatory Affairs
- Perform periodic site reviews and reviews of registrant's purchasing process, disposition and inventory records and security measures. Monitor acquisition of controlled substances and verify registration and justification for use. Provide training in controlled substances policies and procedures for registrants and authorized users. Approve use of controlled substances in animal usage protocols for IACUC.
- Research Subjects Protection Program
- Assist ORA and DEHS in collecting information on authorized use of controlled substances by investigators using animal or human subjects.
- Unit Registrant
- Maintain DEA and MNBP registrations. Exercise signature authority to purchase and dispose of controlled substances used within that Unit. Ensure proper use, storage and disposal of controlled substances and maintenance of disposition records at each location. Properly store and use controlled substances, and maintain disposition records. Ensure an annual inventory is conducted by each location, obtain a copy and send a copy to ORA on an annual basis. Report inventory discrepancies to ORA. Report significant inventory discrepancies as required by DEA and MNBP regulations.
There are no appendices for this policy.
There is no FAQ for this policy.
- 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 consitant 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
-
To obtain a copy of a historical policy,
e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.
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