Approved by the: Amendments approved by the:

University Senate - April 20, 2000 Administration - July 26, 2000 Board of Regents - no action required Senate Consultative Committee - May 3, 2001 University Senate - September 20, 2001 Administration - December 4, 2001 Board of Regents - no action required

Effective July 1997

Responsible University Officer
Vice President for Research

Responsible Office
Department of Environmental Health and Safety
Office of Regulatory Affairs

Policy Statement

In conducting research and teaching activities with controlled substances, University authorized departments, units and employees must comply with federal and state laws and regulations regarding their uses, including registration with DEA and MNBP, storage requirements, inventory maintenance and substance disposal.

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.

The Department of Environmental Health and Safety and the Office of Regulatory Affairs are responsible for monitoring compliance.

Reason for Policy

The University has responsibility to assure that departments, units and employees will comply with all applicable laws and internal requirementsto safely handle and prevent diversion of controlled substances used in research when procuring, storing, using and disposing of them.

• Who Should Know This Policy?
• Related Information
• Contacts
• History
• Exclusions
• Definitions
• Responsibilities
• Procedure
• Forms/Instructions

Who Should Know This Policy

NO - President
NO - Provost / Chancellor / Provost
YES - Vice President / Vice Chancellor
YES - Dean
YES - Director / Department Head / Chair
YES - Principal Investigator
YES - Faculty
YES - Resource Responsibility Center Mgr.
YES - Area Manager
NO - Other Accounting / Finance Personnel
NO - All Employees
YES - Other Groups - Those involvedin using controlled substances.

Regents Policy - Animal Care and Use
Regents Policy - Use of Human Subjects in Research
Controlled Substances Act, Code of Federal or Substance Regulations (21 CFR, part 1300 to end)
Minnesota Rules (Minnesota Board of Pharmacy, Chapter 6800. 4210 to 6800.4250)
Guide to Regulation of Controlled Substances
Department of Environmental Health Services
Office of Regulatory Affairs

History

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 holdthe DEA and MNBP licenses in the name of the University Unit." Since theUnit Registrant does still hold some personal responsibility as the DEA andMNBP registrant, the entry in the revision history was changed to reflectthis.

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 beperformed; Policy Statement, Reason, Definitions and Responsibilities sectionsrewritten and clarified. Procedures rewritten to reflect the changes describedabove. Added forms section.

Effective: July 1997

To obtain a copy of a historical policy,e-mail the U Policy Librarian at process@tc.umn.edu or call 624-4372.

Exclusions

This policy does not apply to controlled substances dispensed by a practitioner to a patient in the course of professional practice asauthorized by his/her license.

Definitions

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. Extracted guidelines are available on the DEHS Guide to Regulation of Controlled Substances.

Department of Environmental Health and Safety (DEHS)
The University of Minnesota Department of Environmental Health and Safety

Disposal
Disposal of controlled substances that are in the original container or original form and that are outdated, surplus or no longer intended for use.   Disposal also applies to small quantities of controlled substances that are residual (often referred to as waste) or have been adulterated 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 section of the United States Department of Justice that establishesregulations for the handling and use of controlled substances.

Employees/Members of the University
Faculty, staff and any other individuals employed by the University, 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. Members do not include students taking courses, attending classes or enrolled in an academic program unless they meet one of the other criteria.

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 whichthey practice, to dispense a controlled substance in the course of professional practice.

Location
A building, room or set of contiguous or adjacent rooms where controlledsubstances are stored or used. A location is managed by a single Universityemployee, has a single address and is designated by a Unit or by DEHS toserve as asingle MNBP registration site.

Location Registrant
A University employee authorized by his/her Unit to hold a MNBP registration to obtain controlled substances from a designated Unit Registrant, and to store, use and properly dispose of controlled substances at a single location. Location Registrants who use Schedule I or II controlled substances in their research or meet other relevant criteria may qualify to hold individual DEA licenses. The exemption requires approval of DEHS, Regulatory Affairs and the Unit head.

Minnesota Board of Pharmacy (MNBP)
The agency authorized by Minnesota statute to regulate controlled substances.

Registration
Formal grant of specific authority by the DEA and/or Minnesota Board of Pharmacy (MNBP)

Regulatory Affairs
The Office of Regulatory Affairs in the Office of the Vice-President forResearch which is responsible for ensuring compliance of University of Minnesotapersonnel with internal policies 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. 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.

Unit
A Unit is a department or other administrative structure which by size, non-contiguous locations or nature of activity requires separate registration as directed by DEHS.

Unit Registrant
A University employee delegated by his/her Unit to hold a DEA and MNBP registration in the name of the Unit and to order, store, distribute, use and disposeof controlled substances within that Unit.

Responsibilities

Authorized Personnel
Properly use and maintain disposition records of controlled substances.

Department of Environmental Health and Safety
Maintain a current list of all registration holders. Approve security ofstorage facilities of all registrants. Conduct a final inspection when aregistration holder or registration address becomes inactive. Periodicallyreview eachregistration holder's purchasing process, disposition and inventoryrecordsand security measures. Periodic site reviews. Establish Unit definitions.

Department/Unit Head
Designate the Unit Registrant for the unit and sign registration applications for all registrants in the Unit. Maintain a record of applications for licensure for all registrants within the unit. Maintain a record of justificationfor each controlled substance used by each registrant. Provide a list ofallregistrants and record of justifications to DEHS.

Location Registrant
Maintain a MNBP registration. Provide the Unit Head with a justification for each controlled substance to be acquired for use in research or teaching. Justification may be evidenced by the number of an approved IACUC or IRB application, the number of a funded research project, a course description or syllabus, or other written description of the research or teaching activity in which controlled substances are used. Properly store and use controlled substances, and maintain appropriate disposition records. Supervise useby authorized personnel. Conduct annual inventory of controlled substancesused at that location. Notify Unit Registrant and DEHS of discrepanciesfoundin 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.

Research Subjects Protection Program
Assist DEHS and the Office of Regulatory Affairs in collecting information on authorized use of controlled substances by investigators using animalor human subjects.

Sponsored Projects Administration
Assist DEHS and Regulatory Affairs in collecting information on authorized use of controlled substances by investigators managing a sponsored project.

Unit Registrant
Maintain DEA and MNBP registrations.  Exercise signature authority to purchase and dispose of controlled substances used within that Unit and for which a justification is on record. Maintain current list of Location Registrants and authorized users within the Unit. Ensure proper use, storage and disposal of controlled substances and maintenance of disposition records.   Conduct annual inventory of Unit Registrantpurchase and disposition records.  Notify DEHS and University Police of inventory discrepancies.

Procedures

To ensure compliance, the following procedures are included:

2.1.4.1 Receiving and Using Controlled Substances
2.1.4.2 Storing and Disposing of Controlled Substances

Forms/Instructions

In support of this policy, the following forms are included:

• Application for Registration of Controlled Substance Researcher (Minnesota Boardof Pharmacy)
• Researcher Controlled Substance Perpetual Inventory
• Controlled Substance Registration
• Report of Theft or Loss of Controlled Substances (DEA)

Procedure 2.1.4.1

Responsible University Officer
Vice President for Research

Responsible Office
Department of Environmental Health and Safety
Office of Regulatory Affairs

Receiving and Using Controlled Substances

A Department or Unit intending to use controlled substances for research or teaching must have one Unit Registrant with Drug Enforcement Administration (DEA) and the Minnesota Board of Pharmacy (MNBP) registrations held in the name of the Department or Unit.  The Unit Registrant purchases or authorizes purchases and disposal of controlled substances for Location Registrants within the Department or Unit. Unit registrants, using a form obtained from DEHS, may grant power of attorney to the Department Head or another Unit Registrant to order controlled substances and execute DEA order forms when the Unit registrant is unavailable.  The power of attorney form must be attached to each order form and may be revoked at any time.

All principal investigators or other primary responsible persons within the department who store and/or use controlled substances at a specific location for research or teaching must be registered with the MNBP (i.e. be a "Location Registrant") and be administratively associated with a Unit Registrant. Purchases may only be made using the Unit Registrant's registration number. Upon approval of the Unit Head, the Department of Environmental Health and Safety (DEHS), and Regulatory Affairs, an investigator who uses Schedule I or II drugs in research or meets other relevant criteria may be excepted from this system and may hold an individual DEA license for purchase and use of controlled substances in research or teaching at the investigator's location. Requests for exemptions must be made in writing on a form provided by DEHS. Exemptions are renewed annually at the time of registration renewal.

Each Unit Registrant must provide DEHS with a copy of the Unit DEA and MNBP registrations at the time of registration and renewal. In addition, the Unit Registrant must provide DEHS with a list of MNBP registrants (and other DEA registrants if they occur) and authorized users within the Unit on an annual basis, including name, registration number and location. DEHS must be notified when a registration address changes or becomes inactive.

Along with each registration there must be a record justifying use of each controlled substance used in research or teaching. This justification may be the number of an approved IACUC or IRB application, the number of a funded grant, a classroom syllabus or course plan, or other description of research or teaching activity.

Once the controlled substance(s) is received, the package must be opened by the Registrant or Authorized Personnel to verify the contents and any discrepancies should be rectified with the sender. If necessary, DEHS should be contacted.  The Unit Registrant must ensure that records are maintained of all transactions involving the purchase, receipt, use, transfer and disposal of controlled substances.  The Location Registrant is responsible for maintaining the records at each Location and providing the Unit Registrant with a copy of the Inventory Record on an annual basis.  The Registrant or Authorized Personnel making the transaction must be the one to complete the record.

Pharmacies dispensing controlled substances must maintain internal policies and procedures governing procurement, use, storage, dispensing and disposal of controlled substances. These policies and procedures must be available for review by the DEHS. Controlled substances shall not be dispensed for use in human and animal research unless the appropriate oversight committee has approved the protocols for their use.

DEHS will review each registration holder's purchasing and inventory processes and records, and security measures when a registration or registration address becomes active or inactive. DEHS and the Office of Regulatory Affairs will review registrants periodically during the active registration interval.

Procedure 2.1.4.2

Responsible University Officer
Vice President for Research

Responsible Office
Department of Environmental Health and Safety
Office of Regulatory Affairs

Storing and Disposing of Controlled Substances

All registrants must provide effective controls and procedures to guard against theft and diversion of controlled substances. Controlled substances must be stored separate from other drugs or materials in a securely locked, substantially constructed cabinet. The following criteria are considered in determining security requirements: the type of activity, the type and form of controlled substance, the quantity of controlled substance, the location of the premises, the type of building construction, the type of vault, safe, and secure enclosures, the adequacy of key control systems, the adequacy of electric detection and alarm systems, the extent of unsupervised public access, the adequacy of supervision over employees with access, procedures for handling visitors, the availability of local police and the adequacy of the use and disposal tracking system (detailed security requirements are in sections 1301.71-1301.76 of the Code of Federal Regulations).

An accurate, continuing and current record of the acquisition, use and disposal of controlled substances shall be maintained at each location. Separate records shall be maintained for each Schedule I and II controlled substances. Separate records shall be maintained by the registrant for each registered location and for each independent activity for which the registrant is registered. Purchasing and inventory records must be maintained for 3 years. The registrant shall conduct an annual inventory and reconciliation as part of a self-audit. A copy of the completed self-audit must be submitted to the Department of Environmental Health and Safety (DEHS) prior to registration renewal. The disposition records or log will be reviewed by DEHS and the Office of Regulatory Affairs when it conducts a periodic on-site review of controlled substances as required by the Drug Enforcement Administration (DEA) and the Minnesota Board of Pharmacy (MNBP).

The log, or disposition record, will include the following information:

• Name of the substance for each finished form of the substance
• Number of units or total volume of each finished form in each commercial container
• Number of commercial containers of each finished form received
• Expiration date and lot numbers of the containers received
• Name, address and registration number of the source from which the containers were received
• Amount of each finished form transferred or used, including the name and address of the person(s) to whom it was given, the date of transfer, the name of the individual who used the substance and the reason it was used
• If controlled substances are compounded or aliquotted, each new container must be labeled and tracked as with the original container. (Note that Federal law and IACUC guidelines prohibit use of non-pharmaceutical grade drugs for anesthesia, analgesia, euthanasia or for any survival procedures in live animals, unless there is no adequate commercial preparation available.)
• Number of units or volume of the finished forms and/or commercial containers disposed of in any other manner, as well as the date and manner of the disposal

Any inventory discrepancy of controlled substances must be reported to the University Police and DEHS immediately upon discovery.

The person having custody of the controlled substance must dispose of outdated, surplus or no longer intended for use, and waste controlled substances according to Federal regulations.  The disposal of controlled substances must be recorded on DEA Form 41, "Registrants Inventory of Drugs Surrendered". They may be transferred to DEHS for disposal or individual arrangements may be made with companies that dispose of pharmaceuticals.

DEHS and Regulatory Affairs will periodically review each registration holder's purchasing and disposition records, inventory and security measures.