Chapter 47 – Controlled Substances Program

DRAFT

Contents

Approved by Laurel Davis
Revised 9/30/2021

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. Controlled Substances Screening and Training
• 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
• Appendix B. Berkeley Lab Controlled Substances Registration Form
• Appendix C. Berkeley Lab Controlled Substances Program Screening Form
• Appendix D. Records
• Appendix E. Chain of Custody Form

Note:
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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) requirements. 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

Workers who have access to, 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
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 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. See Appendix A. Completes Controlled Substances training and screening 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. The Berkeley Lab Controlled Substances Registration Form is in Appendix B. Maintains all required records listed in Appendix D Provides an adequate lockable storage cabinet or safe that meets security requirements. Reviews the Exempt Chemicals Preparations List for substances to use 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. LBNL is required to notify the DEA 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 proposed changes 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 Work Planning and Control (WPC) Activities involving controlled substances. 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 and screening
Subcontract Administrator	Maintains Procurement policies, procedures, and systems for the purchase of controlled substances Maintains records as noted in Appendix D 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
Controlled Substances Program Administrator or designee	Administers and directs the day-to-day 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 Work Planning and Control (WPC) Activities involving controlled substances. Approves/disapproves all orders for controlled substances Advises on labeling requirements for DEA-exempt preparations Maintains records as noted in Appendix D Reviews/approves all secure storage locations Communicates with Laboratory personnel to resolve any security concerns Establishes points of contact, as necessary 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 DOE annual controlled substances inventory report compiled by Property Department Facilitates transfer of custody when authorized custodian leaves Notifies the Security Manager of any theft or loss of a controlled substance Coordinates disposal of controlled substances Maintains contract with an appropriate vendor for proper disposal (as applicable) Assists Laboratory personnel in packaging material for disposal as necessary Processes contractor invoices for disposal (as applicable) Provides guidance for disposal of 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 Prepares a biennial inventory per DEA requirements. Authorizes distribution to another DEA registration. 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.
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
Human Resources	Performs required background checks Communicates with the Program Administrator about the results of the background checks
Receiving	Receives and secures controlled substances for all locations Initiates Chain of Custody and maintains a copy Completes Controlled Substances training and screening

47.6 Definitions

Term	Definition
Access	Individuals who have the combination or key to the storage location or who 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 access.
Authorized controlled substances custodian	A Berkeley Lab worker responsible for overall possession of a controlled substance
Authorized controlled substances worker	A Berkeley Lab worker 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 transfer to the controlled substances custodian or authorized worker.
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 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, Schedule V substances having the lowest.
DEA registrant	The Laboratory Director who obtains and maintains the DEA registration. This responsibility is delegated to the Laboratory Deputy Director.
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.
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.”
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.
PO	Purchase order
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.
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.
Worker	The term worker is used to denote employees, affiliates, and others who are authorized to have access to controlled substances.

47.7 Required Work Processes

Work Process A. General Requirements
Work Process B. DEA Registration
Work Process C. Berkeley Lab Registration
Work Process D. Controlled Substances Screening and Training
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 1300-1399).
3. Authorized custodians are encouraged to review the Exempt Chemical Preparations List for substances that are not controlled substances. If purchased, custodians coordinate with the Program Administrator to implement DEA-required labeling.
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 immediately notify the Program Administrator of any theft or loss of material. LBNL is required to notify the DEA within 24 hours of discovery.

Work Process B.  DEA Registration

At a minimum, for each separate physical location (e.g., Aquatic Park (B977), Emery Station East (B978), Donner Building (B001), and the Berkeley Lab Main Site [Hill]) that wishes to use controlled substances in research, a DEA registration must be obtained and maintained by the Controlled Substances Program Administrator for the Schedule materials used at that location.

Work Process C.  Berkeley Lab Registration

All workers who will handle, manipulate, access, receive, or ship controlled substances must register with the Program Administrator as 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 communicate with the Program Administrator in advance of any desired changes with respect to:

• The storage location or configuration
• The quantity or type of controlled substance
• The personnel having access to the controlled substance

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

Work Process D.  Controlled Substances Screening and Training

In accordance with DEA regulations, all workers who are authorized custodians, authorized workers, or others who have access must be screened for past felony and misdemeanor convictions and past illegal drug use. If an individual has not previously completed a background check as part of the hiring process, Human Resources will initiate a background check with the vendor used by the Laboratory.

Each worker who intends to qualify as an authorized custodian, worker, or who has access will complete the Controlled Substances Program Screening Form as part of the Controlled Substances training (EHS0811). 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 worker 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 C.

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. 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 I or II controlled substances require additional DEA forms to complete the order. These forms will be completed by the Controlled Substances Program Administrator or the Subcontract Administrator (buyer) who has Power of Attorney to sign those forms.

Work Process F.  Receiving and Transferring Controlled Substances

All controlled substances are received at the Building 69 Receiving Department. The Program Administrator will coordinate with Property Management personnel and 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.

Note that for Schedule I or II controlled substances, there may be some cases where the controlled substances must be shipped directly to the address on the DEA registration. In these situations, the Program Administrator will coordinate receipt with Property Management and the authorized custodian and communicate that information to 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:

• Receiving stores the package in a locked location and initiates the Chain of Custody (COC) Form and informs the requester and the Program Administrator that the package has been received.
• The Program Administrator coordinates transfer of the controlled substance from Receiving to the authorized custodian, including communication with Property Management.
• The controlled substance custodian or worker secures the controlled substance in the approved, locked repository and initiates the inventory record in conjunction with Berkeley Lab Property Management.
• Copies of the COC for each controlled substance will be held by the authorized custodian, the Program Administrator, and Facilities Receiving.

If any controlled substance is transferred to another registered location (e.g., Aquatic Park 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 and coordinated with Property Management.

• The transferring authorized custodian initiates a COC for the controlled substance to be transferred. The receiving authorized custodian or worker signs the COC. Both must verify the amount of material received is accurately reflected on the COC.
• If the substance will not be used immediately and must be stored for any length of time, the receiving authorized custodian must provide adequate lockable storage.
• The receiving custodian must initiate an inventory/use log.

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 must be stored in a substantially constructed, securely locked cabinet or safe. UL burglar-resistant locks are preferred and padlocks and hinges must have the mounting screws or bolts of the hasp inaccessible when the door is closed and lock is fastened. The storage cabinet and location must be approved by the Program Administrator in advance of its purchase or installation.

• The safe or cabinet cannot be placed in a hallway or corridor.
• The storage unit must only be used for controlled substances and their inventory logs, unless approved by the Program Administrator.
• Do not transfer a controlled substance from its original container for storage purposes.
• For keyed locks, the keys must be in the physical custody of an authorized custodian or worker at all times. Do not store keys in a drawer or on the wall.
• When an authorized custodian or worker is no longer authorized (leaves the Laboratory, changes assignments, etc.), retrieve the key or change the combination of the lock. Be sure to update your Berkeley Lab registration with the Program Administrator.
• If your storage cabinet must be moved, notify the Program Administrator for approval of the new location.

Schedule I-II substances may be stored with Schedule III-V substances, but must be approved by the Program Administrator in advance.

Maintain all records of receipt, use and disposal of all controlled substances as noted in Appendix D.  The types of information required on an inventory/use log are 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 substances.
2. The Program Administrator will conduct a preliminary inventory to identify exactly what containers, substances, and quantities need to be disposed.
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.

47.8 Source Requirements

• 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

47.9 Other Driving Requirements

• BUS-50, University of California Business and Finance Bulletins, Controlled Substances Program, May 5, 2009
• Research Advisory Panel of California (RAPC), Department of Justice, Office of the Attorney General, State of California

47.10 Appendices

Appendix A. Inventory/Use Log
Appendix B. Berkeley Lab Controlled Substances Registration Form
Appendix C. Berkeley Lab Controlled Substances Program Screening Form
Appendix D. Records
Appendix E. Chain of Custody Form

Appendix A. Inventory/Use Log

Controlled substances custodians are responsible for maintaining an accurate inventory and usage log of controlled substances. Controlled substances projects may vary, so different forms may be used to track the controlled substances. The Program Administrator works closely with each controlled substances custodian to ensure they have an appropriate system for this documentation. The following are required:

1. Upon initial approval of a new controlled substances project, initiate an inventory to track the approved substances. Show the initial inventory as “zero” if no controlled substances have been received.
2. Begin an inventory/use log when you receive the controlled substance.
3. Add the specific information for the material received to the inventory/use log. Make sure all quantities can be accounted for between the amount received, all uses, and any remaining inventory.
4. The Program Administrator will contact you annually to conduct the annual inventory with Property Management.
5. Keep the inventory/use log for two years from the ending date of the inventory.
6. Each inventory/use log must contain the following information (as required by the DEA):
   1. The name of the substance
   2. The finished form of the substance (e.g., 10-mg tablet, 10-mg/ml ampoule, etc.)
   3. The number of units of volume in each commercial container (e.g., 100-tablet bottle; 10-milliter ampoule, etc.)
   4. The number of finished form units or volume dispensed
   5. Additional information includes what it was used for (as applicable), the date of use, the number of units or volume dispensed, the initials of the individual that dispensed or administered the substance, and any notes, including whether a container is being held for disposal or quality control.
   6. If the substance is Schedule I or II, make an exact count or measure of the contents.
   7. If the substance is Schedule III, IV, or V, make an estimated count or measure of the contents unless the container holds >1,000 tablets or capsules, in which an exact count must be made.

Appendix B. Controlled Substances Program Registration Form

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

Appendix C. Controlled Substances Program Screening Form

Go here to download a pdf of the Controlled Substances Program Screening form.

Appendix D. 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 per 41 CFR 109	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
	Biennial inventory per DEA requirements	Minimum of two years from the date of execution.

Appendix E.  Chain of Custody Form

Click here to download a pdf of the Chain of Custody form. Contact the Program Administrator if an alternate form needs to be developed for a specific situation.

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