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Standard Operating Procedure

Using Controlled Substances for Research


SCOPE:

This document describes the activities of using controlled substances for research and who is responsible for each.

LINKS:

Using Controlled Substances for Research (policy)

Using and Disposing of Controlled Substances (procedure)

Purchasing, Receiving, and Storing Controlled Substances (procedure)

DEFINITIONS:

Authorized Personnel (Authorized Users or AU): A University employee authorized to use controlled substances by a Unit Registrant who may also serves as the AUs 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 and Minnesota Board of Pharmacy, Chapter 6800.

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Disposal: Disposal of controlled substances that are in the original container or original form and that are outdated, surplus or no longer intended for use.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 includes 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 establishes regulations 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.

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 building, room or set of contiguous or adjacent rooms where controlled substances are stored or used. A Location is managed by a single University employee and has a single address.

Mandatory DEA-related questionnaire: This questionnaire is intended to ensure that those who have access to controlled substances: a) do not have felony drug convictions; b) have not had a Drug Enforcement Administration (DEA) license revoked or surrendered for cause; and c) have not had an application for registration with the DEA denied. The questionnaire applies to University employees and any other individuals, including students, volunteers and visitors, who have access to controlled substances for University research purposes.

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

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

Research: Any investigative activity engaged in by University personnel using University facilities or resources regardless of funding source.

Research Education and Oversight (REO): A department within the Office of the Vice President for Research that is responsible for ensuring that University of Minnesota personnel comply with internal policies and local, state and federal regulations.

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 DEA registration.

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

Section 1: Registering

Responsibility Activity
Department Head 1.Designate a Unit Registrant for each Unit. Unit Registrants must hold a DEA registration and have sole authority over the purchase of controlled substances in their Unit.
Unit Registrant

2.Complete DEA registration applications and renewals, as directed on each form. Copy DEHS on DEA correspondence.

3.Designate a person of responsibility for each location (e.g., laboratory) within the Unit using controlled substances.

Unit Registrant or Principal Investigator

4.Designate all Authorized Users for this location and have them sign the Authorized Users Signature Log.

5.DEA registrations must be returned upon termination of employment at the University.

Section 2: Purchasing

Responsibility Activity
Unit Registrant

1.Obtain DEA Forms 222 for the purchase of Schedule I and II substances. This form may NOT be modified and requires the Unit Registrant signature.

Unit Registrant or designee

2.Initiate the ordering of controlled substance(s) from Boynton Health Service Pharmacy or Veterinary Medical Center Pharmacy using EFS Internal Sales Voucher Request Form.

Unit Registrant

3.Approve all Unit purchases of controlled substances for research.

  • Power of Attorney may be granted to another person, preferably to a department head or senior administrator and not a Unit Registrant, to obtain and execute DEA Form 222. This must be documented in writing and a copy of the documentation be sent with each order form. The DEA Power of Attorney form is available on the Controlled Substances webpage.

Section 3: Receiving

Responsibility Activity
Unit Registrant or Authorized User

Note: All controlled substance shipments must be processed and stored in a safe as soon as possible after receipt. Shipments of Schedule I and II will be delivered to the address on the Form 222. Process each controlled substance order received, as follows:

  1. Open the package and verify the contents.
  2. Initial and date the purchase receipt and file with the other controlled substance records. Provide Unit Registrant with a copy of receipt.
  3. Enter the following information into the disposition record:
    • name of substance
    • strength or concentration (e.g., mg/ml or mg size of tablets)
    • final form (liquid, tablets, etc)
    • amount per container (e.g., number of tablets or ml per bottle)
    • date received
    • number of containers received
    • from whom the substance was received
    • initial of person processing shipment

Section 4: Storing/Securing

Responsibility Activity
Unit Registrant
  1. Ensure that controlled substances are stored in a safe that is bolted to an immovable object.
  2. Ensure that controlled substances are stored in a safe whenever they are not in use.
    • Controlled substances must be stored separately from other drugs and materials.
    • Access to the controlled substances safe must be limited to the minimum number of people necessary to conduct the research.
    • Schedule III-V controlled substances may be stored in the same safe as Schedule II controlled substances.

Section 5: Labeling

Responsibility Activity
Authorized User
  1. Ensure that each controlled substance container that has been removed from its original container, or has been compounded or diluted, is labeled according to federal and state regulations. Labels of all controlled substances used in research must include the following:
    • name of substance
    • schedule of drug
    • lot number
    • date of dilution and initials / expiration date no more than 30 days after dilution
    • final strength or concentration of controlled substance
    • volume or amount of substance per container
  2. Ensure that the compounding or diluting of a controlled substance is documented in the Disposition Record.
    • The act of compounding each concentration of the solution and the number of new containers must be documented.
    • Each new container must be accounted for and labeled in the same manner as original containers.

Section 6: Using

Responsibility Activity
Authorized User
  1. Record each use of a controlled substance in the Controlled Substance Disposition Record, the Single Drug Disposition Record and/or the Combined Drug Disposition Record. The information that must be recorded, includes:
    • date of use
    • name of drug
    • strength or concentration of drug
    • purpose of use (i.e., protocol number or other info)
    • amount used
    • amount disposed of, if any
    • amount combined or diluted, if any
    • amount transferred, if any
    • initials of user
  2. Controlled substances use must also be documented in research records/lab notebooks.

Section 7: Disposing

Responsibility Activity
Authorized User
  1. Ensure that each controlled substance is disposed of in accordance with the regulations.
  2. Controlled substances may be transferred to DEHS for disposal using the controlled substances disposal form. Disposal is necessary when controlled substances are expired, will no longer be used, or a lab closes-out. Contaminated controlled substances in a syringe may be disposed of by injecting it into a slurry bottle (supplied by DEHS) and writing the information on the disposal form.
    1. Slurry bottles must be locked in the safe.
    2. Follow the instructions on the DEHS disposal website when the slurry bottle is almost full to arrange for pick-up.
    3. At the time of pick up by DEHS, retain a copy of the disposal form for your records after DEHS and laboratory staff have each signed the disposal form.

Section 8: Maintaining and Retaining Records

Responsibility Activity
Unit Registrant and Authorized Users 1. Complete the Disposition Record. The person performing a task (e.g., receiving, using, disposing) is responsible for documenting the necessary information in the Disposition Record
Unit Registrant

2.Ensure that the records documenting the purchase, receipt, storage, use, transfer or disposal of each controlled substance are maintained for a minimum of three years.

3.Ensure that the mandatory DEA-related questionnaire is signed by the Authorized Users prior to using controlled substances for research. File these confidential documents in a secure place.

Section 9: Inventory

Responsibility Activity
Unit Registrant
  1. Perform annual inventory of all controlled substances stored at the registration site and reconcile the actual amount with the Disposition Records. This inventory is required by University policy.
  2. Send a copy of all location inventories to DEHS.
    • An inventory includes counting the number of opened and unopened containers and documenting the number of containers and the amounts contained. This is compared with the Disposition Record and any discrepancy is identified.
  3. Perform the initial investigation of any discrepancy found in the inventory.
  4. Perform additional investigation of discrepancy, as needed.
  5. If inventory and Disposition Records cannot be reconciled, report discrepancy within 24 hours to the DEA (use DEA Form 106), and DEHS. In case of obvious theft or break-in, notify the University of Minnesota Police Department immediately.

Section 10: Inspection

Responsibility Activity
REO Inspect the storage location, security and all associated records of controlled substances used by the Unit Registrants and/or Authorized Users. This periodic inspection may be scheduled or unscheduled.
DEA Inspect the storage location, security and all associated records of controlled substances used by Unit Registrants and/or Authorized Users. These inspections may be made without notice to the Registrant.
Unit Registrant Maintain records in a manner that allows them to be easily provided to inspectors and cooperate with inspecting authorities.