Using Controlled Substances for Research

Responsible Officer

Myron Frans

Senior Vice President for Finance and Operations

Owner

Katharine Bonneson

Assistant Vice President for University Health and Safety

Primary Contact

Sabine Fritz

Last Revised

08-9-2016

Effective Date

07-1-1997

Policy Statement

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, 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.

Drug Enforcement Administration (DEA) Registrants must:

Maintain a current DEA registration whenever controlled substances are being used
Require any person that handles controlled substances to complete a DEA-based questionnaire
Keep a record of the questionnaire until that person no longer handles controlled substances
Authorize the purchase, use, and disposal of controlled substances
Maintain an accurate list of authorized users of controlled substances
Supervise the use of controlled substances
Conduct a physical inventory of controlled substances at least every two years
Maintain all records for at least three years
Report any significant volume discrepancies to University Health and Safety (UHS), University of Minnesota Police Department (UMPD) and DEA

Authorized users must:

Complete and submit the DEA-based questionnaire to the DEA Registrant
Comply with the directions for using controlled substances given by the Registrant
Maintain accurate records of the acquisition, use, and disposition of controlled substances
If authorized to purchase controlled substances, follow pharmacy purchasing guidelines
Use proper personal protective equipment and adhere to safe practices while using controlled substances
Report any significant volume discrepancies to the Unit Registrant

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 the practioner's license.

This policy does not cover teaching activity performed within a clinical environment. However, clinical teaching activities must comply with DEA and Minnesota MNBP.

Reason for Policy

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.

Procedures

Research Medication Ordering (Coming Soon)

Forms/Instructions

Appendices

Frequently Asked Questions

Contacts

Subject	Contact	Phone	Email
Primary Contact	Sabine Fritz	612-625-7227	[email protected]

Definitions

Authorized Personnel: A University employee authorized to use controlled substances by a DEA Registrant who also serves as the employee's direct supervisor.
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 in the Unit.
Disposal: Disposal 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: 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.
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 has a DEA Registrant with which it is associated.
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 competency 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 generalizable knowledge.
Unit: Any organizational entity within the University that has budgetary authority. Includes, but is not limited to, colleges, departments, centers, institutes, offices and programs.

Responsibilities

Authorized Users: Properly use controlled substances and maintain disposition records; perform activities with controlled substances as directed by the DEA Registrant, sign Authorized Users Signature Log and complete the DEA-based questionnaire for employee screening procedures as described in 21CFR1301.90.
University Health and Safety (UHS): 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 Training tutorial regarding policies and procedures for registrants and authorized users; provide guidance and support to researchers; approves use of controlled substances in animal usage protocols for IACUC.
Provide slurry bottles to researchers as needed and pick up controlled substances for disposal according to policy and regulations. Periodically review security and compliance procedures of controlled substance storage facilities.
Department/Unit Head: Designate the DEA Registrant for the Unit.
DEA Registrant: Maintain DEA registration. 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. Supervise use by authorized users. Conduct biennial inventory of controlled substances. Report inventory discrepancies to UHS. Report significant inventory discrepancies as required by the DEA and MNBP administrative rules 6800.4800.

Related Information

Related Policies

Board of Regents Policy: Animal Care and Use
Board of Regents Policy: Research Involving Human Participants
Administrative Policy: For-Cause Investigations Related to Research Compliance Concerns

Other Related Information

The Controlled Substances Act
Code of Federal Regulations (21 CFR, part 1300 to end)
Minnesota Board of Pharmacy Rules, Chapter 6800. 4200 to 6800. 4800
Controlled Substances Training tutorial
Department of Environmental Health & Safety

History

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

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