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.
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.
Drug Enforcement Administration (DEA) Registrants must:
Maintain a current DEA registration whenever controlled substances are being used
Complete the online tutorial: Controlled Substances prior to using controlled substances
Authorize the purchase, use, and disposal of controlled substances
Maintain an accurate list of authorized users of controlled substances
Conduct or assign to designee a physical audit of controlled substances annually
Maintain all records for at least two years. Report any volume discrepancies to University Health and Safety (UHS)
Authorized users must:
Complete the online tutorial: Controlled Substances prior to using controlled substances
Sign the Authorized User list
Comply with the directions for using controlled substances given by the Registrant or lab manager
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 volume discrepancies to the DEA Registrant
Perform the DEA Initial and Biennial Inventory
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 practitioner's license.
This policy does not cover teaching activity performed within a clinical environment. However, clinical teaching activities must comply with DEA and Minnesota Board of Pharmacy (MNBP).
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.
Assistant Vice President for University Health and Safety
Sabine Fritz
Definitions
Authorized User
A University employee authorized to use controlled substances by a DEA Registrant
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 assisting laboratories in ordering, storing, using and disposing of controlled substances in the Unit.
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
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 not research.
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
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.
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 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. Perform controlled substances audits of DEA registrants laboratories.
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. Conduct University required annual audits comparing disposition records to safe content, noting all discrepancies. Report inventory discrepancies to UHS. Report significant inventory discrepancies as required by the DEA and MNBP administrative rules 6800.4800.
Eliminates the DEA Questionnaire by adding the questions to the authorized user signature log.
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.
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.
Administrative Policy