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Controlled Substances in Research and Development

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    Title:

    Controlled Substances in Research and Development

    Publication date:

    10/06/2021

    Effective date:

    10/20/2021

    BRIEF

    Policy Summary

    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.
    No controlled substance or controlled substance analogue may be created unless prior approval is obtained from the Program Administrator in the Environment, Health and 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 and affiliates who have access to, receive, 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:

    Controlled Substances Program Plan

    Contact Information

    Controlled Substances Program AdministratorEHS Division
    [email protected]

    Title:

    Controlled Substances in Research and Development

    Publication date:

    10/20/2021

    Effective date:

    10/20/2021

    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 and affiliates who have access to, receive, 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 1300-1399).
    2. Berkeley Lab will maintain DEA registrations (Work Process B) for each separate physical location where controlled substances are used.
    3. All personnel who have access to controlled substances must register with the Program Administrator (Work Process C) and complete training and screening, including a background check initiated by Human Resources (Work Process D; required by the 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 controlled substances. If such substances are purchased, custodians coordinate with the Program Administrator to implement DEA-required labeling.
    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 be purchased only 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 theft or loss of material within one business day of discovery.
    3. The authorized custodian must communicate with the Program Administrator in advance of any desired changes with respect to:
      1. The storage location or configuration (Work Process G).
      2. The quantity or specific substance to be used.
      3. The personnel having 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 Program Administrator will conduct a preliminary inventory to identify exactly what containers, substances, and quantities need to be disposed of.
    3. The Program Administrator determines an appropriate vendor for the controlled substances disposal and works with the custodian to set up a purchase requisition.
    4. Once disposal arrangements are in place, the Program Administrator will coordinate with Property Management to conduct a disposal inventory prior to packing up the controlled substances for shipment. Note: The disposal inventory and shipment of the material must occur on the same day.

    E. Roles and Responsibilities

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

    Role

    Responsibility

    Laboratory Director

    Obtains and maintains appropriate DEA research registrations per 21 CFR 1301.13(j). This authority is delegated to the Laboratory Deputy Director for Operations. Berkeley Lab is exempt from fees in accordance with 21 CFR 1301.21.

    Laboratory Deputy Director for Operations

    As delegated by the Laboratory Director, serves as the Responsible Official for ongoing oversight of the Controlled Substances Program. The responsibility for day-to-day implementation of the Controlled Substances Program is re-delegated to the Controlled Substances Program Administrator.

    Authorized controlled substances custodian (Authorized custodian)

    • Uses the Work Planning and Control (WPC) Activity Manager system to document controlled substances projects.
    • 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.
    • Maintains proper security controls.
    • Completes Controlled Substances training and screening.
    • Reviews the Exempt Chemical Preparations List for substances that are not controlled substances and coordinates with the Program Administrator to implement DEA labeling requirements.
    • Reports any theft or loss of a controlled substance to the Program Administrator immediately. Berkeley Lab is required to notify the DEA 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 proposed changes to the Program Administrator of:
      • Storage configuration or location.
      • Quantity or substance required for research.
      • Personnel having access to the controlled substance.

    Authorized controlled substances worker (Authorized worker)

    • Reads and accepts the conditions of WPC Activities involving controlled substances.
    • Reports any suspicions of illegal use or diversion of a controlled substance.
    • 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 and the Program Administrator.
    • 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 and screening.

    Subcontract Administrator

    • Maintains Procurement records.
    • Processes purchase requisitions.
    • May complete DEA-222 forms for the purchase of Schedule I or II controlled substances within the current registration and power of attorney.

    Accounts Payable

    • Maintains invoice and payment records to vendors of controlled substances.

    Receiving

    • Receives and secures controlled substances.
    • Initiates Chain of Custody and maintains a copy.
    • Completes Controlled Substances training and screening.

    Program Administrator or designee

    • Administers and directs the Controlled Substances Program in accordance with the authority re-delegated by the Laboratory Deputy Director.
    • Obtains and maintains appropriate DEA research registrations and coordinates review and approval by the Research Advisory Panel of California (for Schedule I research).
    • Receives, reviews, and maintains a file of all Berkeley Lab controlled substances registration forms.
    • Reviews and makes recommendations for WPC Activities involving controlled substances.
    • Advises on labeling requirements for DEA-exempt preparations.
    • Reviews/approves all secure storage locations.
    • Notifies the Berkeley Lab Security Manager of a theft or loss of a controlled substance.
    • Participates in the initial and annual Property Management inventory, and ensures that an initial inventory is conducted even if there are no controlled substances present to inventory.
    • Reviews the DOE annual controlled substances inventory report compiled by Property Department.
    • Facilitates transfer of custody when authorized custodian leaves.
    • Interacts with appropriate authorized custodians and authorized workers, and agencies, as needed.
    • Monitors the Federal Register for additions to the Controlled Substances List.
    • Assists authorized custodians with compliance, if necessary.
    • Coordinates the disposal of controlled substances.
    • Authorizes the creation or synthesis of a controlled substance for research purposes.
    • Authorizes the transfer of controlled substances to or from Berkeley Lab.
    • Authorizes distribution to another DEA registration.
    • Prepares a biennial inventory per DEA requirements.
    • Provides Controlled Substances training.
    • Approves/disapproves purchase of controlled substances.
    • Completes and signs DEA-222 forms for the purchase or supply of Schedule I or II controlled substances within the current registration and power of attorney.
    • Maintains records.

    Human Resources

    • Performs background checks for those noted above.
    • Communicates with the Program Administrator about the results of background checks.

    Property Management

    • Performs initial and annual physical inventory and conducts inventories for transfers and disposal.
    • Submits inventory reports to DOE per 41 CFR 109.
    • Maintains appropriate inventory records per 41 CFR 109.

    F. Definitions/Acronyms

    Term

    Definition

    Authorized custodian

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

    Authorized worker

    A Berkeley Lab worker 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 transfer to the controlled substances custodian or authorized worker. 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.

    Controlled substance

    A drug or other substance regulated by the Department of Justice/Drug Enforcement Administration (DEA) in Sections 21 CFR 1300–1399 and specifically identified in Schedules I–V. A controlled substance used for research purposes requires a specific DEA registration. The Schedules are based on the potential for abuse, with Schedule I substances having the highest potential for abuse and Schedule V substances having the lowest.

    Access

    The access of those individuals who have the combination or key to the storage location or who 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 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

    Listed substance

    An ingredient in the manufacture of a controlled substance. Listed substances are divided into List I and List II, based on their importance in the manufacturing process. Listed substances have threshold amounts established by the DEA Administrator. These thresholds apply to single or multiple transactions (within a month) and require reporting by the distributor of the chemical. There are no reporting requirements for Berkeley Lab because the Laboratory does not distribute these chemicals; it is the "end user."

    DEA registrant

    The Berkeley Lab function that holds the DEA registration(s). At Berkeley Lab, this is the Laboratory Director. This responsibility is delegated to the Laboratory Deputy Director.

    Program Administrator

    The Berkeley Lab employee responsible for administering the Controlled Substances Program in accordance with the authority re-delegated by the Laboratory Deputy Director.

    PO

    Purchase order

    Power of Attorney

    A legal document issued by the DEA Registrant (or designee) to the Program Administrator allowing specific actions to be taken on his/her behalf, including signing DEA registration applications and DEA-222 forms for Schedule I and II controlled substances. A Power of Attorney is also issued by the Program Administrator to the Subcontract Administrator to sign DEA-222 forms to order Schedule I and II controlled substances.

    Research Advisory Panel of California (RAPC)

    A panel formed in the State of California Attorney General's office to review proposed research studies with Schedule I and II controlled substances.65

    Worker

    The term "worker" is used to denote employees, affiliates, and others who are authorized to have access to controlled substances.

    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 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, Controlled Substances Screening and Training 

    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 AdministratorEHS Division
    [email protected]

    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

    9/30/2021

    2.1

    L. Davis

    Periodic review

    All

    Minor

    DOCUMENT INFORMATION

    Title:

    Controlled Substances in Research and Development

    Document number

    03.06.001.000

    Revision number

    2.1

    Publication date:

    10/20/2021

    Effective date:

    10/20/2021

    Next review date:

    10/20/2026

    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

    • 41 CFR 109, Department of Energy Property Management Regulations
    • 21 CFR 1300-1399, Regulations for Controlled Substances
    • Title 21 United States Code (USC), Controlled Substances Act

    Other Driving Requirements

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

    Implementing Documents

    Document Number

    Title

    Type


    Inventory/Use Logs

    Form

    N/A

    Controlled Substances Program Registration

    Form

    N/A

    Controlled Substances Program 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, Controlled Substances Screening and Training 

    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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