Chapter 47
CONTROLLED SUBSTANCES PROGRAM PLAN

Contents

Approved by Dan Best
Revised 08/13

47.1 Policy
47.2 Scope
47.3 Applicability
47.4 Exceptions
47.5 Roles and Responsibilities
47.6 Definitions
47.7 Required Work Processes

Work Process A. General Requirements
Work Process B. DEA Registration
Work Process C. Berkeley Lab Registration
Work Process D. Employee Screening
Work Process E. Purchasing Controlled Substances
Work Process F. Receiving and Transferring Controlled Substances
Work Process G. Storage of Controlled Substances
Work Process H. Disposal of Controlled Substances

47.8 Source Requirements
47.9 Other Driving Requirements

47.10 Appendices

Appendix A. Inventory/Use Log and Examples
Appendix B. Berkeley Lab Controlled Substances Registration Form
Appendix C. Records
Appendix D. Requirements for the Storage of Controlled Substances
Appendix E. Chain of Custody Form
Appendix F. Disposal of Schedule I or II Controlled Substances
Appendix G. Disposal of Schedule III, IV, and V Controlled Substances

NOTE:
. . . . . Denotes a new section.
. . . . . . . . Denotes the beginning of changed text within a section.
. . . . . . . . Denotes the end of changed text within a section.

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47.1 Policy

Use of controlled substances in research at Berkeley Lab must comply with all federal regulations, laws, and Department of Energy (DOE) Orders. The 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 of the Environment/Health/Safety (EHS) Division. No controlled substance may be transferred to or from Berkeley Lab without approval from the Program Administrator, EHS.

47.2 Scope

The purpose of this program is to ensure that all controlled substances are used appropriately and within all Drug Enforcement Administration (DEA) regulations and DOE requirements.

47.3 Applicability

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

47.4 Exceptions

There are no exceptions to the requirements of the Controlled Substances Program.

47.5 Roles and Responsibilities

Role

Responsibility

EHS Division Director

Obtains and maintains appropriate DEA research registrations. Berkeley Lab is exempt from fees in accordance with 21 CFR 1301.21.

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 to the Program Administrator, who will initiate an investigation by Protective Services
  • Never transfers controlled substances from another institution to Berkeley Lab without prior approval from the Berkeley Lab Controlled Substances Program Administrator
  • Never transfers controlled substances from Berkeley Lab to another institution without prior approval from the receiving institution and the Berkeley Lab Controlled Substances Program Administrator
  • Never synthesizes a controlled substance without specific authorization from the Berkeley Lab Controlled Substances Program Administrator
  • Maintains proper security controls (always has possession of the key, never gives out the combination to the storage cabinet, etc.)
  • Makes accurate entries on the inventory/use log for any controlled substance he or she uses. An inventory/use log and examples are provided in Appendix A.
  • Completes Controlled Substances training
  • Maintains accountability for all controlled substances for which he or she is assigned
  • Understands and maintains awareness of all activities with controlled substances for which he or she is accountable
  • Maintains an up-to-date Berkeley Lab registration form for his or her project and passes an employee screening. The Berkeley Lab Controlled Substances Registration Form and Employee Screening form is in Appendix B.
  • Maintains all required records listed in Appendix C
  • Provides an adequate lockable storage cabinet or safe that meets security requirements. Storage requirements are found in Appendix D.
  • Reviews the Exempt Chemicals Preparations List for substances to use that are not subject to DEA regulation
  • Reports any loss of a controlled substance to the Program Administrator within 24 hours of discovery
  • Enters chemicals into the Chemical Management System
  • Participates in the initial, annual, and terminal Property Management inventory
  • Reports to the Program Administrator about any changes 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 to the Program Administrator
  • Never transfers controlled substances from another institution to Berkeley Lab without prior approval from the Berkeley Lab Controlled Substances Program Administrator
  • Never transfers controlled substances from Berkeley Lab to another institution without prior approval from the receiving institution and the Berkeley Lab Controlled Substances Program Administrator
  • Never synthesizes a controlled substance or controlled substance analogue without specific authorization from the Berkeley Lab Controlled Substances Program Administrator
  • Maintains proper security controls (always has possession of the key, never gives out the combination to the storage cabinet, etc.)
  • Makes accurate entries on the inventory/use log for any controlled substance he or she uses (see Appendix A)
  • Completes Controlled Substances training
  • Passes the employee screening process

Subcontract Administrator

  • Maintains Procurement policies, procedures, and systems for the purchase of controlled substances
  • Maintains records as noted in Appendix C
  • 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
  • Maintains receiving records and initiates Chain of Custody
  • Completes Controlled Substances training

Controlled Substances Program Administrator or designee

  • Administers and directs the day-to-day Controlled Substances Program
  • Receives, reviews, and maintains a file of all Berkeley Lab Controlled Substances registration forms
  • Approves/disapproves all orders for controlled substances
  • Maintains records as noted in Appendix C
  • Reviews/approves all secure storage locations
  • Communicates with Laboratory personnel to resolve any security concerns
  • Establishes points of contact, as necessary
  • Reviews DOE annual controlled-substances inventory report compiled by Property Department
  • Facilitates transfer of custody when authorized custodian leaves
  • Notifies the Security Manager of the significant theft or loss of a controlled substance
  • Coordinates disposal of controlled substances
    • Maintains contract with an appropriate vendor for proper disposal
    • Assists Laboratory personnel in packaging material for disposal as necessary
    • Processes contractor invoices for disposal
    • Provides and maintains Controlled Substances Disposal Instructions for both Schedule I-II and Schedule III-V controlled substances.
  • 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
  • Authorizes the creation of a controlled substance for research purposes
  • Authorizes the transfer of controlled substances to or from Berkeley Lab
  • Provides Controlled Substances training
  • Submits biennial report to DEA.
  • Submits annual report to the DEA Registrant
  • Authorizes distribution to another DEA registration.
  • Completes and signs DEA-222 forms for the purchase of Schedule I or II controlled substances within the current registration and power of attorney.

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

Human Resources

  • Performs required employee screening
  • Communicates with the Program Administrator about the results of the employee screening

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
  • Completes Controlled Substances training

47.6 Definitions

Term

Definition

Authorized controlled substances custodian

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

Authorized controlled substances worker

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

Chain of Custody (COC) Form

Laboratory documentation showing the transfer of a substance from one person to another. The form is used primarily when the substance is delivered to Building 69 Receiving prior to delivery to its ultimate-use location.

Chain of Custody

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 Agency (DEA) in Sections 21 CFR 1300-1308 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, Schedule V substances having the lowest.

Direct access

Individuals who have the combination or key to the storage location or who directly handle, manipulate, transfer, or take similar action with the material or container. Persons in the 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 into 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 EHS Division Director who obtains and maintains the DEA registration

PO

Purchase order

Program Administrator

The Berkeley Lab employee responsible for administering the Controlled Substances Program

Power of Attorney

A legal document issued by the DEA Registrant to the Program Administrator and Subcontract Administrator allowing specific actions to be taken on his/her behalf.

47.7 Required Work Processes

Work Process A. General Requirements
Work Process B. DEA Registration
Work Process C. Berkeley Lab Registration
Work Process D. Employee Screening
Work Process E. Purchasing Controlled Substances
Work Process F. Receiving and Transferring Controlled Substances
Work Process G. Storage of Controlled Substances
Work Process H. Disposal of Controlled Substances

Work Process A.  General Requirements

  1. Controlled substances include those defined in Schedules I, II, III, IV, and V of the Controlled Substances Act (Title 21 USC Section 812).
  2. The Drug Enforcement Administration (DEA) is the regulatory agency for controlled substances (21 CFR 1300-1308).
  3. 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.
  4. Absolutely no controlled substances may be transported between another institution and Berkeley Lab or from Berkeley Lab to another institution without prior approval from the Program Administrator.
  5. No controlled substances or controlled substance analogue may be created at any Laboratory location unless prior approval is obtained from the Program Administrator.
  6. The controlled-substance custodian or worker must notify the Program Administrator of any significant loss of material within one business day of discovery.

Work Process B.  DEA Registration

At a minimum, for each separate physical location (e.g., Berkeley BioCenter West, Joint BioEnergy Institute, Donner Building, Berkeley Lab Main Site [Hill]) that wishes to use controlled substances in research, a DEA registration must be obtained and maintained by the EHS Division Director for the Schedule materials used at that location.

Work Process C.  Berkeley Lab Registration

All employees who will handle, manipulate, access, receive, or ship controlled substances must register with the Program Administrator and pass an employee screening (required by DEA). Persons who register and pass the employee screening are authorized controlled-substance workers (authorized workers). Persons who have custodial responsibilities for the controlled substances are authorized controlled-substance custodians (authorized custodians). The controlled-substance custodian must update the Berkeley Lab registration information when:

Registration forms and updates (Appendix B) are filed with the EHS Controlled Substances Program Administrator.

Work Process D.  Employee Screening

In accordance with DEA regulations, all employees who are authorized custodians or authorized workers must be screened for past felony and misdemeanor convictions and past illegal drug use. Each employee who intends to qualify as an authorized custodian or worker will complete the Employee Screening Form and submit the form to the Human Resources representative (noted on the form). The Human Resources Department will contact the employee to complete the required forms for submission to the screening vendor. Any false information, omission of information, or misuse of controlled substances will jeopardize the employee’s position with the Laboratory. The information gathered from the screening process will not preclude the employee from conducting research at Berkeley Lab with controlled substances, but will be considered as part of the evaluation of qualifications. It is recognized that information from foreign countries may not be available; however, this information will be considered as part of the overall qualification. See Appendix B.

Work Process E.  Purchasing Controlled Substances

Procurement of controlled substances is limited to eBuy and one-time purchase orders. Blanket orders may not be used. If purchased through eBuy, a request for approval is automatically sent to the Program Administrator by the Procurement system. Concurrently, notification is sent to Property Management and Facilities Receiving.  The approval is required prior to authorization of the procurement. If the individual is not registered with the Program Administrator, the individual is informed of the requirements and approval is withheld until the appropriate Berkeley Lab registration is obtained and all registration requirements are fulfilled. Once the eBuy request is approved, an automatic e-mail is sent to the requestor, and manually sent to Property Management and Facilities Receiving, notifying them of the purchase. The item is automatically noted as “receiving required” in the Facilities Receiving iBox system.

If purchased through a one-time purchase order and correctly categorized as a controlled substance, an automatic approval will have been sent to the Program Administrator prior to receipt by the vendor. Concurrently, notification is sent to Property Management and Facilities Receiving. The vendor will contact the Program Administrator for the DEA registration number. If the requisition has not been correctly categorized, the buyer will correct the categorization and the automatic approval will be initiated. If the researcher is not registered with the Program Administrator, the researcher is informed of the requirements and approval is withheld until all registration requirements are fulfilled. The vendor will contact the Program Administrator for the DEA registration. Once the request is approved, an e-mail will be sent to Property Management and Facilities Receiving, notifying them of the purchase. The item must be marked by Procurement as “receiving required.”

Note: Schedule II controlled substances require additional DEA forms to complete the order. These forms will be completed by the Controlled Substances Program Administrator.

Work Process F.  Receiving and Transferring Controlled Substances

All controlled substances are received at the Building 69 Receiving Department. Property Management personnel will contact the authorized custodian to initiate the inventory.  Controlled substances must be stored in a lockable, sturdy cabinet in Building 69 dedicated to this purpose, with no other items or chemicals while in Receiving.

When the item is delivered to B69 Receiving, Receiving personnel will acknowledge receipt in the iBox Financial Management System. The following steps are completed:

If any controlled substance is transferred to another registered location (e.g., Potter Street to the Hill), the authorized custodian initiates a COC form. Transfers may only take place between individuals within the same registration. Any transfer of controlled substances between individuals on other registrations must be approved by the Program Administrator.

Work Process G.  Storage of Controlled Substances

Each authorized custodian must provide adequate storage and maintain inventory records that comply with the DEA regulations. Controlled substances, Schedules III-V, must be stored in a substantially constructed, securely locked cabinet or safe.

Schedule I-II substances may be stored with Schedule III-V substances as long as the storage unit meets the additional following criteria:

Maintain all records of receipt, use and disposal of all controlled substances as noted in Appendix C.  An example of an inventory/use log and examples of the information required is shown in Appendix A.

Work Process H.  Disposal of Controlled Substances

Disposal of excess controlled substances will be through Berkeley Lab contracts facilitated by the Program Administrator.

  1. The controlled-substance custodian notifies the Program Administrator of the need to dispose of excess controlled substance.
  2. The controlled-substance custodian follows instructions for Schedule I or II substances in Appendix F.
  3. The controlled-substance custodian follows instructions for Schedule III, IV, or V substances in Appendix G.

47.8 Source Requirements

47.9 Other Driving Requirements

47.10  Appendices

Appendix A. Inventory/Use Log and Examples
Appendix B. Berkeley Lab Controlled Substances Registration Form
Appendix C. Records
Appendix D. Requirements for the Storage of Controlled Substances
Appendix E. Chain of Custody Form
Appendix F. Disposal of Schedule I or II Controlled Substances
Appendix G. Disposal of Schedule III, IV, and V Controlled Substances

Appendix A. Inventory/Use Log and Examples

Go here to download a pdf of the Inventory/Use Log and Examples.

Appendix B. Berkeley Lab Controlled Substances Registration Form

Go here to download a pdf of the Berkeley Lab Controlled Substances Registration form.

Appendix C. Records

Role

Record Name

Duration

Procurement Department

  • Purchase requisition
  • Vendor contract(s)

Minimum two years from the date of execution

Accounts Payable

Invoices and record of payment

Minimum two years from the date of execution

Subcontract Administrator

Power of attorney

Ongoing

Facilities Receiving

Chain of Custody (COC) — copy

Minimum two years from the date of initiation

Authorized custodian

  • Chain of Custody (COC) — original
  • Inventory/use logs
  • Proof of delivery to the disposal vendor
  • Copy of shipping documents (vendor form)
  • Schedule I and II records must be kept separate from records of Schedule III-V substances. All records must be kept for a minimum of two years.
  • For Schedule I or II substances, the purchaser’s copy of the DEA 222 form must be kept for a minimum of two years.

Authorized worker

Chain of Custody (COC) — original (for transfers to another physical location)

Minimum of two years from the date of execution.

Property Department

Property report for DOE Order 580.1A

Ongoing

Program Administrator

Registration form/updates

As long as the project is active

 

Power of attorney

Ongoing

 

Requests for transfer between registrations

Minimum of two years from the date of execution.

 

DEA-222 forms

Minimum of two years from the date of execution

 

Annual report to the EHS Division Director

As needed

 

Biennial report to DEA

Minimum of two years from the date of execution.


Appendix D. Requirements for the Storage of Controlled Substances

Several controlled-substances storage options are shown below. These are not the only ones available, but they do represent some choices. If you are using a current configuration that you believe meets the requirements, contact the Program Administrator for approval.

Features to Look For

Other Requirements

Resources

This site has a variety of storage cabinets that are suitable for storage of controlled substances.

This site has a variety of storage cabinets that are suitable for storage of controlled substances.

Product Snapshots

Brand: Sandusky

  • Dimensions: 30"W x 12"D x 30"H
  • Weight: 50 lbs.
  • Lifetime guarantee
  • Welded steel with powder coat paint finish
  • Keyless electronic locking system
  • Cost: $169

Brand: Korden Drug Lockers

A higher level of security for controlling Class II drugs and other pharmaceuticals

Interbank-Equipment/Korden Drug Storage Lockers offer a formidable barrier against unauthorized access with an outer case of heavy-duty 16-gauge steel and 14-gauge doors resting on a full-length hinge with 3-point locking.

Authorized entry first requires the opening of a mechanical manager’s key lock. Once open, access is granted only after the correct digital code is entered into the electronic lock. With every entry, an audit stamp is recorded by the lock with user information, date and time of entry. Every transaction via the electronic lock will be recorded enabling a digital trail that is irrefutable. 

Cost: $1,840


Appendix E.  Chain of Custody Form

Click here to download a pdf of the Chain of Custody form.


Appendix F. Disposal of Schedule I or II Controlled Substances

Controlled Substances Disposal Instructions
Schedule I-II Controlled Substances

To disposal of Schedule I or II drugs, pre-approval is required by the disposal subcontractor, EXP Pharmaceutical Inc. (EXP).

  1. Complete the EXP Schedule I & II Return Request Form
    1. Read the instructions carefully. Careful completion of the form will avoid rejection of your request by EXP. Any questions regarding the form should be referred to EXP at (800) 350-0397, ext. 247, or the Controlled Substance Program Administrator.
    2. Fill out the form as follows:
    3. DEA Name: University of California
      DBA Name: Lawrence Berkeley National Lab
      Address: One Cyclotron Road
      City, State, Zip Code: Berkeley, CA 94720
      EXP Acct: 1872
      Buying Group: Leave blank
      Shipper Phone Number: Researcher’s phone number
      Authorized Registrant: Researcher’s name
      DEA License: Contact the Program Administrator
      DEA Exp. Date: Contact the Program Administrator

  2. Fax the completed form to EXP. Retain a copy for your records. Do not mail the drugs at this time.
  3. EXP will mail a completed DEA 222 form and pre-addressed mailing label to the Program Administrator. The DEA-222 is the authorization to ship the drugs.
  4. Contact Property Management, ext. 6569, for an appointment to inventory the drugs prior to packing and mailing. Property Management will come to your location to complete the inventory. Note: The disposal inventory and shipment of the material must occur on the same day.
  5. Once the inventory is completed, pack the material securely. Insert each drug into a separate ziplock bag (provided by Property Management during the final inventory), then into a second ziplock bag. Use filler material to pack the contents securely. Insert the DEA 222 form into a ziplock bag before placing it in the package. Use the pre-addressed mailing label provided by EXP for each package. Record the EXP account number on the label (see above).
  6. The items must be tracked during shipment. Any freight carrier may be used (UPS, FedEx, or USPS). Track the shipment and get confirmation of receipt.
  7. Retain copies of the shipment and receipt confirmation for your records. If you do not receive the return receipt, contact EXP at (800) 350-0397, ext. 247.
  8. When EXP has disposed of the drugs, it will send the Program Administrator proof of destruction, the DEA-41 form. When this is received, the invoice can be certified. The Program Administrator will file the DEA-41 form in the EXP files.

Appendix G.  Disposal of Schedule III, IV, and V Controlled Substances

Controlled Substances Disposal Instructions
Schedule III-V Controlled Substances

Pre-approval for mailing a Schedule III-V drug is not required.

  1. Complete the EXP Schedule III-V Inventory Form
    1. Read the instructions carefully. Any questions regarding the completion of the form should be referred to EXP at (800) 350-0397, ext. 247, or the Controlled Substance Program Administrator. Retain a copy for your records.
    2. Fill out the form as follows:

      DEA Name: University of California
      DBA Name: Lawrence Berkeley National Lab
      Address: One Cyclotron Road
      City, State, Zip Code: Berkeley, CA 94720
      EXP Acct: 1872
      Buying Group: Leave blank
      Shipper Phone Number: Researcher’s phone number
      Authorized Registrant: Researcher’s name
      DEA License: Contact the Program Administrator for the specific registration.
      DEA Exp Date: Contact the Program Administrator for the specific date.

  2. Contact Property Management, ext. 6569, for an appointment to inventory the drugs prior to packing and mailing. Property Management will come to your location for the inventory. Note: The disposal inventory and shipment of the material must occur on the same day.
  3. Once the forms are completed, package the material securely. Insert each drug into a separate ziplock bag, then into a second ziplock bag. Use filler material to pack the contents securely. Filler material is available in Building 69. Insert the original Schedule III-V Inventory Form into a ziplock bag before placing it in the package. Keep a copy for your records. Address the package to:

    EXP Pharmaceutical Services Corp
    48021 Warm Springs Boulevard
    Fremont, CA 94539

  4. The package may be shipped by any freight carrier (USPS, UPS, FedEx, etc.). Track the shipment and get confirmation of receipt.
  5. Retain a copy of the shipping documents and confirmation of receipt for your records. If you do not receive the return receipt, contact EXP at (800) 350-0397, ext. 247.
  6. When EXP has disposed of the drugs, it will send the Program Administrator proof of destruction, DEA-41 form. Once this is received, the invoice can be certified. The Program Administrator will file the DEA-41 form in the EXP files.

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