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Controlled Substances in Research and Development

    Title:

    Controlled Substances in Research and Development

    Publication date:

    8/30/2013

    Effective date:

    8/30/2013

    BRIEF

    Policy Summary

    Controlled-substance use in research at Berkeley Lab must comply with all federal regulations, laws, and Department of Energy (DOE) directives. Use of these substances requires implementation of best practices in procurement, accountability, security, and disposal.

    No controlled substance or controlled-substance analogue may be created unless prior approval is obtained from the Program Administrator in the Environment/Health/Safety (EHS) Division. No controlled substance may be transferred to or from Berkeley Lab without approval from the Program Administrator in EHS.

    Who Should Read This Policy

    Employees who work with, handle, procure, or facilitate disposal of controlled substances at Berkeley Lab

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    To Read the ES&H Program Details, Go To:

    The Controlled Substances Program Plan

    Contact Information

    Controlled Substances Program Administrator
    Industrial Hygiene Group
    EHS
    DGBest@lbl.gov

    Title:

    Controlled Substances in Research and Development

    Publication date:

    8/30/2013

    Effective date:

    8/30/2013

    POLICY

    A. Purpose

    Controlled-substance use in research at Lawrence Berkeley National Laboratory (Berkeley Lab) must comply with all federal regulations, laws, and Department of Energy (DOE) directives. Use of these substances requires implementation of best practices in procurement, accountability, security, and disposal.

    B. Persons Affected

    Employees who work with, handle, procure, or facilitate disposal of controlled substances at Berkeley Lab.

    C. Exceptions

    Not applicable

    D. Policy Statement

    D.1 General (Work Processes A–D)

    1. Controlled substances include those defined in Schedules I, II, III, IV, and V of the Controlled Substances Act (Title 21 USC Section 812). The Drug Enforcement Administration (DEA) is the regulatory agency for controlled substances (21 CFR 1300-1308).
    2. Berkeley Lab will maintain DEA registrations (Work Process B) for each off-site location and for the Laboratory main site where controlled substances are used.
    3. All personnel who have direct access to controlled substances must register with the Program Administrator (Work Process C) and pass an employee screening (Work Process D; required by DEA).
    4. Each authorized controlled substances custodian (authorized custodian) must provide secure storage and maintain inventory records that comply with the DEA regulations.
    5. Authorized custodians are encouraged to review the Exempt Chemical Preparations List for substances that are not regulated. See http://www.deadiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf.
    6. Absolutely no controlled substance may be transported between another institution and Berkeley Lab or from Berkeley Lab to another institution (which includes transportation between Berkeley Lab locations) without prior approval from the Program Administrator. No controlled substance or controlled-substance analogue may be created at any Laboratory location unless prior approval is obtained from the Program Administrator.
    7. All personnel are required to report any suspicion of illegal use or diversion of controlled substances to the Program Administrator.

    D.2 Acquisition Process (Work Process E)

    Controlled substances may only be purchased through eBuy vendors or a one-time purchase order. Blanket purchase orders may not be used.

    D.3 Custodianship Process (Work Processes F–G)

    1. Per DEA regulation, the substances must be delivered to the address on the registration. For Berkeley Lab, the delivery address is One Cyclotron Road, Building 69, Facilities Receiving. Substances will be tracked by the use of a Chain of Custody document for all transfers between authorized custodians, authorized controlled substances workers (authorized workers), and Berkeley Lab locations (Work Process F)
    2. The authorized custodian or worker must notify the Program Administrator of any significant loss of material within one business day of discovery.
    3. The authorized custodian must update the Berkeley Lab registration information for:
      1. Changes in the storage location or configuration (Work Process G)
      2. Changes in the quantity or specific substance to be used
      3. Changes to the list of persons having direct access to the controlled substances

    D.4 Disposal Process (Work Process H)

    1. The authorized custodian notifies the Program Administrator of the need to dispose of excess controlled substance.
    2. The authorized custodian follows instructions for Schedule I or II substances here: http://www.lbl.gov/ehs/ih/programs/csp/assets/CSdisposalInstrux1_2.pdf.
    3. The authorized custodian follows instructions for Schedule III, IV, or V substances here: http://www.lbl.gov/ehs/ih/programs/csp/assets/CSdisposalInstrux3_5.pdf

    E. Roles and Responsibilities

    Managers, supervisors, and employees must adhere to the provisions of this policy.

    Role

    Responsibility

    EHS Division Director

    Obtains and maintains appropriate DEA research registrations

    Authorized controlled-substances custodian

    (Authorized custodian)

    • Initiates controlled-substance acquisition process for research use
    • Reports any suspicions of illegal use or diversion of a controlled substance
    • Obtains prior approval from the Program Administrator for transfers of controlled substances from another institution to Berkeley Lab
    • Obtains prior approval from the receiving institution and the Berkeley Lab Program Administrator for transfers of controlled substances to another institution
    • Obtains specific authorization from the Program Administrator prior to synthesizing a controlled substance or controlled-substance analogue
    • Maintains an up-to-date Berkeley Lab registration form for the project and passes an employee screening
    • Maintains proper security controls
    • Completes Controlled Substances training
    • Reviews the Exempt Chemical Preparations List for substances not subject to DEA regulation
    • Reports any loss of a controlled substance to the Program Administrator within 24 hours of discovery
    • Maintains accountability for all assigned controlled substances, including purchasing and disposal records and inventory use logs
    • Understands and maintains awareness of all activities with controlled substances for which he/she is accountable
    • Enters chemicals into the Chemical Management System
    • Participates in the initial, annual, and terminal Property Management inventory
    • Provides an appropriate storage configuration for controlled substances
    • Reports any changes to the Program Administrator of:
      • Storage configuration or location
      • Quantity or substance required for research
      • Personnel having direct access to the controlled substance

    Authorized controlled substances worker

    (Authorized worker)

    • Reports any suspicions of illegal use or diversion of a controlled substance
    • Passes the employee screening process
    • Never transfers a controlled substance from another institution or location to Berkeley Lab without prior approval from the Program Administrator
    • Never transfers controlled substances from Berkeley Lab to another institution without prior approval from the receiving institution
    • Never synthesizes a controlled substance or controlled-substance analogue without specific authorization from the Program Administrator
    • Maintains proper security controls
    • Makes accurate entries on the inventory/use log for any controlled substance used
    • Completes Controlled Substances training

    Subcontract Administrator

    • Maintains Procurement records
    • Processes one-time purchase requisitions

    Accounts Payable

    • Maintains invoice and payment records to vendors of controlled substances

    Receiving

    • Receives and secures controlled substances for all locations
    • Initiates Chain of Custody and maintains a copy
    • Completes Controlled Substances training

    Transportation

    • Receives controlled substances for delivery to the research location
    • Signs chain of custody as receiver and relinquisher
    • Completes Controlled Substances training

    Program Administrator or designee

    • Administers and directs the Controlled Substances program
    • Receives, reviews, and maintains a file of all Berkeley Lab controlled-substances registration forms
    • Notifies the Berkeley Lab Security Manager of a theft or loss of a controlled substance
    • Supports the disposal of controlled substances
    • Authorizes the synthesis of a controlled substance for research purposes
    • Authorizes the transfer of controlled substances to or from Berkeley Lab
    • Provides Controlled Substances training
    • Approves/disapproves purchase of controlled substances
    • Maintains records

    Human Resources

    • Performs employee screenings for those noted above
    • Communicates with the Program Administrator about the results of employee screenings

    Property Management

    • Performs initial and annual physical inventory and conducts inventories for transfers and disposal
    • Submits inventory reports to DOE per DOE Order 580.1A
    • Maintains appropriate inventory records per DOE Order 580.1A

    F. Definitions/Acronyms

    Term

    Definition

    Authorized custodian

    A Berkeley Lab employee responsible for overall possession of the controlled substance for a research project

    Authorized worker

    A Berkeley Lab employee authorized to receive, handle, access, or manipulate controlled substances for research purposes

    Chain of Custody Form

    Laboratory documentation showing the transfer of a substance from one person to another. The form is initiated primarily when the substance has been delivered to Building 69 Receiving prior to delivery to the research location. It must also be used if transferring a controlled substance to an authorized worker in another location.

    Chain of Custody (COC)

    Chronological documentation showing the custody, control, transfer, analysis, and disposition of a controlled substance. An identifiable person must always have physical custody of a controlled substance used for research purposes.

    Direct access

    Individuals who have the combination or key to the storage location or who directly handle, receive, manipulate, transfer, or take similar action with the material or container. (Persons who are in the same room at the time the materials are handled but who do not participate in the above activities are not considered as having direct access.)

    eBuy

    E-commerce ordering system used for low-value catalog items from online catalogs for various suppliers. Catalog items that require special approvals are routed for approval when such items are selected for purchase.

    One-time purchase order

    A purchase order that is processed through the electronic procurement system. The item must be correctly categorized to ensure that the appropriate approval is obtained.

    iBox

    A software tracking system that tracks and sorts packages at Laboratory receiving

    DEA registrant

    The Berkeley Lab function that holds the DEA registration(s). At Berkeley Lab, this is the EHS Division Director.

    Program Administrator

    The Berkeley Lab employee responsible for administering the Controlled Substances program

    PO

    Purchase order

    G. Recordkeeping Requirements

    All records will be kept in accordance with 21 CFR 1304.

    H. Implementing Documents

    Document Number

    Title

    Type

    N/A

    Inventory/Use Logs

    Form

    N/A

    Controlled Substances Program Registration

    Form

    N/A

    Controlled Substances Program Employee Screening

    Form

    N/A

    Chain of Custody

    Form

    03.06.001.001

    Controlled Substances Program Plan

    Program

    03.06.001.002

    Work Process A, General Requirements

    Process

    03.06.001.003

    Work Process B, DEA Registration

    Process

    03.06.001.004

    Work Process C, Berkeley Lab Registration

    Process

    03.06.001.005

    Work Process D, Employee Screening 

    Process

    03.06.001.006

    Work Process E, Purchasing Controlled Substances

    Process

    03.06.001.007

    Work Process F, Receiving and Transferring Controlled Substances

    Process

    03.06.001.008

    Work Process G, Storage of Controlled Substances

    Process

    03.06.001.009

    Work Process H, Disposal of Controlled Substances

    Process

    I. Contact Information

    Controlled Substances Program Administrator
    Industrial Hygiene Group
    EHS
    DGBest@lbl.gov

    J. Revision History

    Date

    Revision

    By whom

    Revision Description

    Section(s) affected

    Change Type

    1/2/2012

    1

    Lunsford

    Rewrite for wiki

    All

    Minor

    8/30/2013

    2

    Rothermich

    Update to align with 21 CFR 1300-1321

    All

    Major

    DOCUMENT INFORMATION

    Title:

    Controlled Substances in Research and Development

    Document number

    03.06.001.000

    Revision number

    2

    Publication date:

    8/30/2013

    Effective date:

    8/30/2013

    Next review date:

    8/30/2016

    Policy Area:

    Controlled Substances

    RPM Section (home)

    Conduct of Research & Development

    RPM Section (cross-reference)

     

    Functional Division

    EHS

    Prior reference information (optional)

    RPM Sections 2.23, 11.39, 1.06

    Source Requirements Documents

    • DOE Order 580.1A, Department of Energy Personal Property Management Program Contractor Requirements Document
    • 21 CFR 1300-1321, Regulations for Controlled Substances
    • Title 21 USC 802(6), Controlled Substances Act

    Other Driving Requirements

    • BUS 50, University of California Business and Finance Bulletins, Controlled Substances Program Best Practices Guide, May 5, 2009

    Implementing Documents

    Document Number

    Title

    Type

    N/A

    Inventory/Use Logs

    Form

    N/A

    Controlled Substances Program Registration

    Form

    N/A

    Controlled Substances Program Employee Screening

    Form

    N/A

    Chain of Custody

    Form

    03.06.001.001

    Controlled Substances Program Plan

    Program

    03.06.001.002

    Work Process A, General Requirements

    Process

    03.06.001.003

    Work Process B, DEA Registration

    Process

    03.06.001.004

    Work Process C, Berkeley Lab Registration

    Process

    03.06.001.005

    Work Process D, Employee Screening 

    Process

    03.06.001.006

    Work Process E, Purchasing Controlled Substances

    Process

    03.06.001.007

    Work Process F, Receiving and Transferring Controlled Substances

    Process

    03.06.001.008

    Work Process G, Storage of Controlled Substances

    Process

    03.06.001.009

    Work Process H, Disposal of Controlled Substances

    Process

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