Program Scope: See above

Exclusions

Stanford University’s CS Program and institutional DEA registration does not cover:

1. Individuals with personal DEA registrations: Any individual possessing a personal DEA registration for research use is prohibited from filing controlled substance purchase requests under the University’s Program. In accordance with their personal DEA registration, such persons shall be individually responsible for proper purchasing, recordkeeping, disposal, and other regulated practices.
2. Use of controlled substances in patient-care at Stanford University: Pharmacists and physicians supporting Vaden Student Health Services and other Stanford clinics shall solely operate under their own DEA registrations.
3. Use of any Schedule I drug: Faculty or Protocol Director must independently obtain individual DEA registrations for any Schedule I drug. See section below on FAQs for Faculty Seeking or Holding Individual DEA Registrations.
4. Off-campus use of controlled substances: When performing research at a non-Stanford facility (such as the Veterans Administration Palo Alto Health Care System) and Stanford’s off-campus research locations (such as Hopkins Marine Station), Stanford Faculty will be subject to the host institution’s controlled substances program. If there is no program, Faculty will need to register independently for an individual DEA registration.

What are controlled substances (CS)?

Controlled substances are drugs and certain other chemicals, both narcotic and non-narcotic, that come under the jurisdiction of federal and state laws regulating their manufacture, sale, distribution, use, and disposal. These controlled substances are regulated by the Federal Drug Enforcement Administration (DEA) and the California Department of Justice (CA-DOJ). The selected drugs are listed in 5 schedules (categories), see the List of DEA Controlled Substances Schedules I-V. See DEA website for more information.

What are precursor chemicals?

Precursor chemicals are chemicals used in the course of legitimate research that can potentially be used in the illicit production of controlled substances, such as methamphetamine, cocaine, heroin, and MDMA (ecstasy). The purchase of precursor chemicals is regulated by the Federal Drug Enforcement Administration (DEA) and the California Department of Justice (CA-DOJ).

See the DEA List I and II Regulated Chemicals. For more information: https://www.deadiversion.usdoj.gov/chem_prog/34chems.htm

See the CA-DOJ, California Code, Health and Safety Code HSC 11100, for list of chemicals. For more information: https://oag.ca.gov/bi/ccsp

Stanford Environmental Health & Safety (EH&S) manages the institutional program which:

1. Oversees initiation and maintenance of the institutional research registration for DEA Schedule II- V controlled substances
2. Coordinates research authorizations for use and transfer of controlled substances involving the University’s DEA Registration
3. Procures and dispenses orders for controlled substances used in research
4. Performs periodic compliance inspections
5. Coordinates the biennial campus-wide inventories and provides report to the DEA
6. Develops and promulgates compliance tools
7. Communicates with agencies on all compliance issues, including reporting lost or stolen controlled substances
8. Provides for appropriate disposal of controlled substances (Schedule II-V) obtained under Stanford’s institutional DEA registration

Participating Faculty or Protocol Director

Participating Faculty or Protocol Director who apply for enrollment to the University’s CS Program for their research using Schedule II-V controlled substances by submitting the Controlled Substance Purchase Request Application (CSP Form 1a) and the Controlled Substances Authorized Researcher Application (CSP Form 2). EH&S will follow with a “Start-up Lab Inspection” with the applicant faculty/Protocol Director and their CS manager described below in the enrollment details.

In order for Stanford to ensure compliance and maintain its institutional DEA registration, it is critical that participating Faculty or Protocol Director clearly understand their responsibilities:

Authorized researchers

Authorized researchers are individuals (e.g. staff, graduate students, undergraduate students, post-docs, or visiting scholars) who are assigned by the participating Faculty or Protocol Director to work with controlled substances within their laboratory, and who have submitted the Controlled Substances Authorized Researcher Application (CSP Form 2) to EH&S.

An authorized researcher is responsible to:

1. Comply with University, federal, and state regulations pertaining to the possession of controlled substances by adhering to Stanford University&s Controlled Substances Program regarding:
   • Authorization
   • Training
   • Security, receipt, storage, use and maintenance of usage log sheets, disposing of controlled substances
2. Take the online Controlled Substances Training (EHS-2125-WEB) available at Axess/STARS
3. Separately maintain Schedule II CS inventory and records from Schedule III-V CS.
4. Reporting theft or loss of controlled substances to participating Faculty or Protocol Director and EH&S at (650) 725-9999.
5. Participating in or conducting program activities such as maintaining online inventory, periodic inspections, biennial campus-wide inventory, etc., if delegated by participating Faculty or Protocol Director.

Benefits of enrolling under Stanford CS Program (using Stanford’s institutional research DEA registration

1. Individual faculty do not have the management responsibility to apply for and to annually renew their individual registrations.
2. Individual faculty do not bear the annual cost of holding a registration.
3. EH&S administers the institutional DEA research registration, which provides various services, including:
   • Support on security and recordkeeping issues
   • Ordering of controlled substances and chemicals (the cost of controlled substances are borne by faculty)
   • Administration of biennial CS inventories

Research requiring authorization from the Research Advisory Panel of California (RAPC)

Faculty or Protocol Director must independently seek authorization from the Research Advisory Panel of California (RAPC) if their research projects specifically involve:

• Any Schedule I controlled substances
• Human research using any Schedule I or Schedule II controlled substances
• Research for the treatment of drug abuse using any drug, scheduled or not

Stanford’s Institutional Review Board (IRB) Office checks protocols to ensure that investigators have sought this authorization, when required. Researchers using Schedule II (in non-human research), III, IV, or V controlled substances need not apply to RAPC.

Applications are available online.

Enrolling in the University’s CS program and purchase approval

Any University Faculty or Protocol Director needing to purchase Schedule II-V controlled substances for research under Stanford’s institutional registration must gain EH&S use/purchasing approval by submitting:

1. The Controlled Substance Purchase Request Application (CSP Form 1a), which identifies the substances to be ordered. This form also provides proof of legitimate research use, via approval from one of the following:
   • Administrative Panel for Laboratory Animal Care (APLAC) for animal research
   • Institutional Review Board (IRB) for human subjects-related research
   • The applicant’s department chairperson
2. Controlled Substances Authorized Researcher Application (CSP Form 2): Only personnel whose submitted forms are cleared by EH&S will be institutionally authorized to access controlled substances.Authorization to access controlled substances will be denied to any personnel who have been convicted of a felony offense relating to controlled substances or who, at any time, had an application for DEA registration denied or registration revoked, in accordance with Section 21 CFR 1301.90.

After receipt and processing of both forms, EH&S will schedule a “Start-up Lab Inspection” with Faculty applicant and their authorized researchers to verify that CS requirements regarding security, storage, training, recordkeeping, and safety are met. A CS Logbook will be provided to the lab for recordkeeping. For questions, please contact EH&S CS Program Office or call (650) 725-7521.

Complying with the requirements of the University’s Controlled Substance Program

Failure to comply with the authorization, storage, security, inventory, and record-keeping processes established within the University’s CS program exposes Stanford to losing its registration, and thereby gravely impacts your and other researchers’ ability to conduct research involving controlled substances.

Background history information

The Federal Drug Enforcement Agency (DEA) considers certain information vital to assessing the likelihood of an employee committing a drug security breach. The need to know this information is a matter of business necessity and essential to overall controlled substances security. In this regard, it is believed that crime convictions and unauthorized use of controlled substances are proper subjects for inquiry.

Thus, Stanford University has an employee-screening component of its Controlled Substances Program. All faculty, protocol directors, staff, post-docs, and students intending to conduct research using controlled substances must complete the Controlled Substances Authorized Researcher Application (CSP Form 2). This online form is then sent to EH&S CS Program Office.

This form fulfills the regulatory requirement to fairly assess the likelihood of personnel to commit a drug security breach. Authorization to access controlled substances will be denied to any personnel who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for DEA registration denied or registration revoked, in accordance with Section 21 CFR 1301.90. Names of all new authorized researchers must be made available to the U.S. Drug Enforcement Administration for criminal history screening. The form also communicates the employees’ or students’ responsibility to:

• Take the online Controlled Substances Training (EHS-2125-WEB) available at Axess/STARS
• Obtain the requisite health and safety training from his or her supervisor on the hazards of working with the controlled substances
• Follow listed work practices, as further detailed in the Program

Reporting a loss, theft or drug diversion

Any loss, stolen, or suspected diversion of controlled substances shall be immediately reported via the Stanford University EH&S Emergency Line at (650) 725-9999.

If the controlled substances are stolen or diverted, the information will be forwarded to Stanford’s Department of Public Safety. The University’s Program then will submit the required loss/theft reports directly to the DEA per 21 CFR 1301.91. If any imminent safety threat exists, contact Public Safety directly at 911 or 9-911 (from a University phone).

If an employee who has knowledge of drug diversion from the University by a fellow employee, the employee has an obligation to report such information to Stanford University’s EH&S Emergency Line, (650) 725-9999. Stanford shall treat such information as confidential and shall take reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing it. Failure to report information related to drug diversion will be considered in determining whether it is permissible to allow an employee to work in a laboratory area.

Consequences of engaging in illicit activities

According to the DEA, employees who possess, sell, use or divert controlled substances will subject themselves not only to state or federal prosecution for any illicit activity, but shall also immediately become subject to independent action regarding their continued employment. Stanford will assess the seriousness of the employee’s violation, the employee’s position of responsibility, and his or her past record of employment in determining whether to suspend, transfer, terminate, or take other action against the employee.

Purchasing controlled substances

Once enrollment in the CS Program has been completed (see CS Program enrollment details above), to order controlled substances, submit: SU Controlled Substance Re-ordering Request (CSP Form 1b) to EH&S. After validating the purchase request, EH&S will notify the requestor of the status of the request. EH&S then facilitates the requested controlled substance purchase using pre-selected vendors. If specific suppliers are identified by the requestor, EH&S will make all possible attempts to fulfill the request and follow-up if the request cannot be fulfilled. It takes approximately three to ten working days to process a purchase request. EH&S will then initiate a journal transfer to charge the PTA for the controlled substances.

For Schedule II purchase requests, submit a separate CSP Form 1b from any Schedule III-V controlled substances purchase request. Records for Schedule II Controlled Substances must be maintained separately from Schedule III-V records.

Central receiving and dispensing process

All authorized controlled substances purchases are delivered to the EH&S’s CS Program Office, located on-campus at the Environmental Safety Facility at 480 Oak Road. All visitors to EH&S must first report to the EH&S Main Building at 484 Oak Road.

Once shipment is received, EH&S notifies the Faculty or Protocol Director, and CS Manager, that the CS can be picked up at EH&S. Only Stanford CS authorized researchers with Stanford ID (or other acceptable form of photo ID) will be allowed to pick up the CS orders and sign the chain of custody logbook. EH&S will maintain documentation of all CS purchases. Authorized researchers must deliver the order directly to their CS storage location specifically listed on the submitted SU Controlled Substance Purchase Request Application (CSP Form 1a).

Inventory and recordkeeping

Per the Code of Federal Regulations (21 CFR 1304), complete and accurate records shall be kept of all controlled substances purchased, manufactured, transferred, or wasted. Therefore the following forms and system shall be used:

• CSP Form 3: Controlled Substance Usage LogsEach authorized Faculty or Protocol Director must maintain an up-to-date, legible usage log of each controlled substance in possession using the SU Controlled Substance Usage Log (CSP Form 3). Each usage log sheet (CSP Form 3) should also document the disposal of remaining CS. Records must be kept locally for at least two years from the final disposition of the controlled substance. Usage Log sheets shall be kept available for periodic audit by EH&S and the DEA.
• ChemTracker 4: CS Inventory must also be included in the online chemical inventory management system (ChemTracker 4).
• CSP Form 1c: Addition or Deletion of Authorized Researchers
  Each authorized Faculty or Protocol Director must maintain an up-to-date list of authorized researchers, any changes to list should be submitted to EH&S using Addition or Deletion of Authorized Researchers (CSP Form 1c).

• CSP Form 4: Biennial inventory submission
  Per 21 CFR 1304.11(b), the University must conduct an inventory of all controlled substances obtained through its institutional DEA registration in one day every two years. On this periodic two-year institutional cycle, each Faculty or Protocol Director must submit a controlled substances inventory on a particular day in January to EH&S. EH&S will assign the date and will send a SU Controlled Substances Biennial Inventory Form (CSP Form 4) to each Faculty or Protocol Director and their CS manager. A separate CSP Form 4 for Schedule II controlled substances inventory will be submitted as needed.

Storage and security

The University’s overall security system involves a coordinated system of physical and administrative controls.

1. Public Safety: Stanford University’s Department of Public Safety has officers who continuously patrol the University and enforce public safety and security.
2. Building Systems: Stanford University’s buildings have card key or key systems to lock buildings after hours, with some facilities also having video cameras stationed at the entrances to buildings.
3. CS Storage: Controlled substances shall be stored in a securely locked, substantially constructed cabinet, located where access is limited. (Note that thiafentanil, carfentanil, etorpine hydrochloride, and diprenorphine must be stored in a safe per 21 CFR 1301.75.)  All CS shall be stored in secondary containment with Schedule II in a separate secondary containment from Schedule III-V.
4. Access: CS access within the laboratory must be limited to the smallest number of authorized researchers necessary to perform related research activities to assure complete accountability and reconciliation of any discrepancy that may result.
5. Screening of Authorized Researchers: All researchers intending to handle controlled substances, including Faculty or Protocol Director, are required to undergo background screening via submission of the SU Controlled Substances Authorized Researcher Application (CSP Form 2).
6. Work Practices: Controlled substances must never be left unattended at any time. Discovery of an unattended controlled substance, or an unsecured storage area, exposes the institution to losing its registration.
7. Containers/Labelling: Controlled substances must not be transferred from their original containers for inventory purposes. Identifying labels must not be removed from the original containers. If the controlled substance is mixed, converted or diluted, the new container must be labeled properly with a bottle number, name of CS, concentration and/or amount, and date of expiration. If the new CS container is not used completely in the same day, a new usage log sheet (CSP Form 3) should be completed.
8. Loss or Theft: Any detected loss or theft of controlled substances must be reported immediately to Stanford University’s EH&S Emergency Line at (650) 725-9999. If the CS is stolen, or diversion is suspected, EH&S will forward the information to the Department of Public Safety. If any imminent safety threat exists, personnel are to contact Public Safety directly at 911 or 9-911 (from a University phone). EH&S will submit the required loss/theft reports directly to the DEA.

Transfers

Intra-campus transfers:

Ownership of CS may only be transferred between owners enrolled in the University’s Program, and such transfer may only occur with specific written approval, granted by EH&S.

An intra-campus transfer of a CS will be approved only if the following criteria are met:

• The original inventory must have been acquired under the Stanford’s institutional DEA registration.
• The Faculty or Protocol Director receiving the CS must submit a SU Controlled Substance Purchase Request Application (CSP form 1a or CSP Form 1b) to EH&S and receive approval from EH&S for such transfer.
• Both parties must maintain documentation of any approved transfer.

Prohibition of transferring controlled substances:

Under no circumstances can controlled substances falling under the institutional registration be transferred into or out of the University campus, or to another individual at another University or institution. Faculty with dual appointments at Stanford University and the VA Palo Alto Health Care System (VAPAHCS) are prohibited from taking or transferring controlled substances into or out of VAPAHCS laboratories. When performing research at VAPAHSC, Stanford Faculty will be subject to VAPAHSC’s Health Care System Memorandum No. 151-04-2, “Procedures for Obtaining, Storing, and Disposing Controlled Substances for Use on Animals in Research Studies.” Also, Faculty with on- and off-campus laboratories are prohibited from taking or transferring controlled substances into or out of on-campus laboratories.

Disposal

Controlled substances must be properly accounted for before disposal and are not allowed to be disintegrated, crushed into powder, and dissolved in water for disposal. Participants of the University’s Controlled Substances Program are to request waste pick-up from the EH&S Hazardous Waste Program by submitting the SU Controlled Substances Disposal Request Form (Form 6). Each usage log sheet (CSP Form 3) should also document the waste pickup.

Categories of waste

• Wasted controlled substances: These include items such as: vials, tubes, or syringes after administration which contain remaining CS but cannot or may not be further utilized; oral liquid, or preparations compounded in error, which contain controlled substances.
• Expired or unused inventory of controlled substances: These include controlled substances which have exceeded their shelf life, unwanted controlled substances, or a drug that has fallen into disuse.

EH&S manages the destruction of properly submitted controlled substances, per the DEA’s requirements.

Note that EH&S only manages the disposal of controlled substances obtained under Stanford’s institutional DEA registration. Individual registrants are responsible for managing the disposal of their controlled substances, per DEA requirements.

General

What are controlled substances (CS)?

Controlled substances are drugs and certain other chemicals, both narcotic and non-narcotic, that come under the jurisdiction of federal and state laws regulating their manufacture, sale, distribution, use, and disposal. These controlled substances are regulated by the Federal Drug Enforcement Administration (DEA) and the California Department of Justice (CA-DOJ). The selected drugs are listed in 5 schedules (categories), see the List of DEA Controlled Substances Schedules I-V. See DEA website for more information.

What is Stanford University’s Controlled Substances and Precursor Chemicals Program?

Research use of selected drugs and precursor chemicals is regulated by the Federal Drug Enforcement Administration (DEA) and the California Department of Justice (CA-DOJ). To assist Stanford personnel in complying with these regulations and University policy, specific institutional requirements have been established for the management of controlled substances and precursor chemicals.

The University has an institutional registration with the DEA for research involving Schedule II-V Controlled Substances. Precursor chemicals may be procured using this institutional registration.

Registrations and purchase approvals

If I already have my own registration with the Drug Enforcement Administration (DEA), do I need to participate in the University’s program?

No. You are expected to continue to administer and manage your own DEA registration. Keep in mind that compliance with federal and state laws and University procedures governing controlled substances and precursor chemicals is required of all individuals and groups associated with Stanford University. These regulations include the following:

• Code of Federal Regulations: Title 21, Chapter II (Parts 1300 to end)
• Health and Safety Code Division 10: California Uniform Controlled Substances Act

How do I enroll under the University’s registration and get purchase approval for CS?

Any University Faculty or Protocol Director needing to purchase controlled substances for research under Stanford’s Institutional Registration must submit to EH&S:

• The SU Controlled Substance Purchase Request Application (CSP Form 1a), which identifies the substances to be ordered. This form also provides proof of legitimate research use, via approval from one of the following:
  1. The Administrative Panel for Laboratory Animal Care (APLAC) for animal research
  2. The Institutional Review Board (IRB) for human subjects-related research
  3. The applicant’s department chairperson

  Note: For Schedule II requests, submit a separate Form 1a because Schedule II Controlled Substances and Schedule III-V must be kept separate.

• The SU Controlled Substances Authorized Researcher Application (CSP Form 2): Only personnel whose submitted forms are cleared by EH&S will be institutionally authorized to access controlled substances.Authorization to access controlled substances will be denied to any personnel who have been convicted of a felony offense relating to controlled substances or who had an application for DEA registration denied or registration revoked at any time, in accordance with Section 21 CFR 1301.90.

How long does it take to process a controlled substance purchase request application?

After enrollment process is completed using SU Controlled Substance Purchase Request Application (CSP Form 1a), future CS purchases using the SU Controlled Substance Re-ordering Request (CSP Form 1b) will take approximately three to 10 working days.

What type of research needs authorization from the Research Advisory Panel of California (RAPC)? How do I get authorization from RAPC?

Faculty and Protocol Directors must independently seek authorization from the RAPC if their research projects specifically involve:

• Any Schedule I controlled substance
• Human research using any Schedule I or Schedule II controlled substance
• Research for the treatment of drug abuse using any drug, scheduled or not

Stanford’s Institutional Review Board (IRB) Office checks protocols to ensure that investigators have sought this authorization, when required. Researchers using Schedule II (in non-human research), III, IV, or V controlled substances need not apply to RAPC.

Get applications for authorization online.

Why do I need my own registration with the DEA for work with Schedule I Controlled Substances? How do I get a registration for Schedule I Controlled Substances?

Per CFR 1301.18, Faculty and Protocol Directors must independently obtain individual DEA registrations. See section below regarding FAQs for Faculty Seeking or Holding Individual DEA Registrations.

Why do I need to have my own registration with the DEA for work with any Controlled Substances off-campus?

When performing research at a non-Stanford facility (such as the Veterans Administration Palo Alto Health Care System) or off of the main campus (such as the Hopkins Marine Station), Stanford faculty will be subject to the host institution’s controlled substances program or, if one does not exist, will need to register independently for an individual DEA registration.

What happens if I do not comply with the requirements of the University’s Controlled Substances Program?

Failure to comply with the authorization, storage, security, inventory, and recordkeeping processes established within the University’s program exposes Stanford to losing its registration, and thereby gravely impacts your and other researchers’ ability to conduct research involving controlled substances and precursor chemicals.

The consequences of engaging in illicit activities are reviewed below.

Researcher authorization and security

Why do I have to provide background history information? Who reviews this information? Where is it filed?

It is the position of DEA that obtaining certain information about employees is vital to fairly assess the likelihood of an employee committing a drug security breach. The need to know this information is a matter of business necessity and essential to overall controlled substances security. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry. Thus, Stanford University has an employee-screening component in its Controlled Substances Program.

All faculty, staff, post-docs, and students intending to conduct research using controlled substances are required to complete the SU Controlled Substances Authorized Researcher Application (CSP Form 2). This form must be sent to EH&S’s Controlled Substances Program Office. Names of all new authorized researchers must be made available to the to the DEA’s field office.

How do I report a loss or theft?

Any loss, stolen, or suspected diversion of controlled substances shall be immediately reported via the Stanford University EH&S Emergency Line at (650) 725-9999. If the controlled substances are stolen or diverted, the information will be forwarded to Stanford University’s Department of Public Safety. The University’s Program will then submit the required loss/theft reports directly to the DEA.

If any imminent safety threat exists, contact Public Safety directly at 911 or 9-911 (from a University phone).

What are the consequences of engaging in illicit activities?

It is the position of the DEA that employees who possess, sell, use, or divert controlled substances will subject themselves not only to state or federal prosecution for any illicit activity, but shall also immediately become subject to independent action regarding their continued employment. Stanford will assess the seriousness of the employee’s violation, the employee’s position of responsibility, and his or her past record of employment, etc., in determining whether to suspend, transfer, terminate, or take other action against the employee.

If I think a co-worker is diverting controlled substances, why do I have to report him/her? How is this done confidentially?

Per 21 CFR 1301.91, the DEA requires that an employee who has knowledge of drug diversion from the University by a fellow employee has an obligation to report such information to Stanford University’s EH&S Emergency number at (650) 725-9999. Stanford shall treat such information as confidential and shall take reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing the information. Failure to report information related to drug diversion will be considered in determining whether it is feasible to allow an employee to work in a laboratory area.

Storing, transferring, inventorying, and disposing CS

How do I store controlled substances?

Controlled substances shall be stored in a securely locked, substantially constructed cabinet, located where access is limited. Note that thiafentanil, carfentanil, etorpine hydrochloride, and diprenorphine must be stored in a safe.

Can I transfer controlled substances to another faculty member on the Stanford campus?

Yes. An intra-campus transfer of a CS will be approved only if the following criteria are met:

• The original inventory must have been acquired under the Stanford’s institutional DEA registration.
• The Faculty or Protocol Director receiving the CS must submit a SU Controlled Substance Purchase Request Application (CSP form 1a or CSP Form 1b) to EH&S and receive approval from EH&S for such transfer.
• Both parties must maintain documentation of any approved transfer.

Can I transfer controlled substances to another individual at another University or institution?

No. Under no circumstances can controlled substances purchased using Stanford’s institutional registration be transferred off the main campus or to another individual at another institution.

I have a dual appointment at Stanford University and the Veterans Administration Palo Alto Health Care System (VAPAHSC). Can I move controlled substances between Stanford University and VAPAHSC?

No. Faculty with dual appointments at Stanford University and the VAPAHCS are prohibited from taking or transferring controlled substances into or out of VAPAHCS laboratories. When performing research at VAPAHSC, Stanford faculty will be subject to VAPAHSC’s Health Care System Memorandum No. 151-04-2, “Procedures for Obtaining, Storing, and Disposing Controlled Substances for Use on Animals in Research Studies.”

Who checks our Controlled Substance Logbook?

Each authorized faculty or Protocol Director must maintain an up-to-date inventory of each controlled substance in their possession using the Controlled Substances Usage Log (CSP Form 3). Records must be kept locally for a minimum of two years from the final disposition of the controlled substance. The Logbook (provided by EH&S) shall be readily available for periodic audit by EH&S and the DEA.

What is the biennial campus-wide inventory?

Per 21 CFR 1304.11(b), the University must conduct an inventory of all controlled substances obtained through its institutional DEA registration in one day every two years. On this designated day, each Faculty or Protocol Director must submit a controlled substances inventory to EH&S. EH&S will assign the date and will send a SU Controlled Substances Biennial Inventory Form (CSP Form 4) to each Faculty or Protocol Director and their CS manager. A separate CSP Form 4 for Schedule II controlled substances inventory will be submitted as needed.

How do I dispose of controlled substances?

Controlled substances must be properly accounted for before disposal. Controlled substances are not allowed to be disintegrated, crushed into powder, and dissolved in water for disposal. They must be picked up by EH&S Hazardous Waste Program by submitting the SU Controlled Substances Disposal Request Form (Form 6). Each usage log sheet (CSP Form 3) should also document the waste pickup.

Note that EH&S only manages the disposal of DEA controlled substances (Schedule II-V) obtained under Stanford’s institutional DEA registration. Individual registrants are responsible for managing the disposal of their controlled substances, per DEA requirements.

Stanford faculty seeking or holding individual research registrations with the Federal Drug Enforcement Agency (DEA) are subject to a number of specific regulatory requirements. The Frequently Asked Questions (FAQs) below are intended to provide guidance on the application process with DEA investigators, and to facilitate understanding of the responsibilities of holding an individual DEA research registration. Stanford University’s Controlled Substances Program is also available for consultation on compliance requirements for individual registrants. Call EH&S at (650) 723-0448.

General

How do I check the schedule of a controlled substance?

See the DEA’s Controlled Substances schedules.

How do I contact the DEA?

Contact information for the DEA is available on their website. The local DEA Office contact information for is:

For Routine Registration assistance about new applications, renewal applications, order forms, or changes to an application or DEA registration: contact a Registration Program Specialist during normal business hours.

For Investigative Matters or Tactical Diversion Squads (TDS): contact a Diversion Investigator or Special Agent during normal business hours.

What to know before seeking registration with the DEA

Can I enroll under Stanford University’s institutional research DEA registration?

Stanford holds an institutional registration for research use of Controlled Substances (for Schedules II -V). Faculty who are interested in considering enrollment in this program should review Controlled Substances Chemicals sections above.

Stanford University’s institutional research DEA registration does not cover:

• Research off the main Stanford University campus
• Research involving Schedule I Controlled Substances
• Use in patient care
• Clinical trials in which participants take medication off-site

In these instances, the faculty member would need to seek his/her own registration (see below).

Coverage under the institutional registration may not be appropriate for every research program use. In such instances, a faculty member may need to apply for an individual research registration.

Questions regarding the institutional registration program, or about individual registration, can be directed to the Controlled Substances Program by calling EH&S at (650) 723-0448.

What are the benefits of enrolling under Stanford’s institutional research DEA registration?

• Individual faculty do not have the management responsibility to apply for and to annually renew their registrations.
• Individual faculty do not bear the annual cost of holding a registration.
• EH&S administers the institutional DEA research registration, which provides various services, including:
  • Support on security and recordkeeping issues
  • Ordering of controlled substances (the cost of controlled substances are borne by faculty)
  • Administration of biennial inventories

What would my responsibilities include if I hold an individual DEA registration?

Under Title 21 Code of Federal Regulations (CFR) 1300-1399, responsibilities of managing an individual DEA registration include:

• Undergoing the application and review process by the DEA
• Ensuring that personnel from your lab who would have access to controlled substances have undergone a screening process
• Ensuring security and recordkeeping requirements
• Renewing DEA registration annually
• Performing biennial inventory of controlled substances stocks
• Sending unused or expired controlled substances to a reverse distributor for disposal
• Reporting any discrepancy in inventory or losses of controlled substances to the DEA

Registration and approvals

How far in advance should I submit the application to the DEA?

After you have determined that your research requires an individual registration (see above), you should submit an application to the DEA approximately three months before your research would require the use of controlled substances. This timeframe should be adequate to complete the DEA’s evaluation and vetting process and then order the controlled substances from the vendor.

Do not submit your DEA application if your research plans are preliminary, or if the faculty member will be traveling extensively.

Once your application is in the DEA queue, the DEA office will want to review and expedite the application in a timely manner. The DEA will need to interact directly with the faculty applicant. Faculty are strongly advised to have their projects well planned before initiating the application process, in order to promptly answer questions posed by the DEA investigator. The DEA office processes hundreds of applications, and any delay in responding to requests for follow-up information may result in significant delays in processing your application.

How do I apply for a DEA registration?

After you have determined that your research needs an individual registration (see above):

1. Apply for a registration online.
2. Complete the online application for a “research” registration using “DEA Form 225.” Note that there are different forms for different DEA registrations (e.g. individual “practitioner” registrations use “DEA Form 224”).
3. After you submit this application electronically, a DEA investigator will contact you for detailed information about the nature of your intended research. This DEA follow-up may occur days to weeks after the online submission. Be prepared to answer (verbally or in writing) questions regarding:
   • The specific controlled substances to be used (along with drug code)
   • The intended research use for each substance (including the specific nature of the proposed research use)
   • The approximate amount of each substance expected to be used annually
   • The name(s) and address(es) of vendor(s)
   • The storage location and a description of local security measures (e.g. a securely locked, substantially constructed cabinet or safe, where access is limited)
   • General building security information (e.g. building alarm system, cardkeys, receptionist), including relative security from theft and other access
   • A list of personnel with access to controlled substances (including name, title, and birth date)

It is important that you respond to requests for information from the DEA investigator completely and in a timely manner (i.e. within five working days). Failure to respond in a timely manner and/or with incomplete information may result in rejection of the application or a significant delay in the application.

When must I seek authorization from the Research Advisory Panel of California (RAPC)?

In addition to holding a DEA registration, you must independently seek authorization from the RAPC if your research project specifically involves:

• Any Schedule I controlled substance
• Human research using any Schedule I or Schedule II controlled substance
• Research for the treatment of drug abuse using any drug, scheduled or not

Applications are available online.

Note that you must have DEA registration and approval from Stanford’s Institutional Review Board (IRB) Office before you seek RAPC approval.

How do I renew my registration?

To renew your registration, go to this website and click on “Renewal Application,” then complete the online application.

Researcher authorization

Why do I have to perform employee screening for my researchers who will work with the controlled substances under my registration? How do I do this?

It is the position of DEA that obtaining certain information about employees is vital to fairly assess the likelihood of an employee committing a drug security breach. The need to know this information is a matter of business necessity and essential to overall controlled substances security. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are proper subjects for inquiry.

The DEA’s employee screening procedures for personnel assigned to work with Controlled Substances are available at 21 CFR 1301.90-93.

The screening process includes:

• Inquiring in writing if the employees have past felony convictions in the last five years, or have used narcotics in the last three years, other than those prescribed by a physician
• Obtaining permission from the employees to make inquiries with local or federal law enforcement regarding felony convictions
• Informing employees of potential disciplinary action for employees who engage in illicit activities
• Informing employees of the regulatory responsibility to report suspect diversion

Questions regarding employee screening for controlled substances access can be directed to the Controlled Substances Program by calling EH&S at (650) 723-0448.

Storage, security, and recordkeeping

How do I store controlled substances?

Storage and security requirements depend upon the schedule of the controlled substances and the type of business registration. The DEA provides general storage and security information.

Questions regarding security requirements can be directed to the Controlled Substances Program at (650) 723-0448.

How do I create and maintain usage logs for controlled substances?

Registrants must track each usage of a controlled substance following these requirements. Questions regarding usage logs can be directed to the Controlled Substances Program at (650) 723-0448.

What additional procurement and recordkeeping requirements apply to Schedule I and II controlled substances?

To purchase a Schedule I or II Controlled Substance, the registrant will need a DEA Form 222. This is a personalized form showing the registrant’s DEA number. This form must be submitted to vendors during the ordering process.

Read more about the additional storage, recordkeeping, and inventory requirements for Schedule I and II Controlled Substances.

How do I conduct a biennial inventory?

Registrants must conduct an inventory of all stocks of controlled substances on hand no later than every two years from the previous biennial inventory date. You are required to maintain copies of your biennial inventory inspection for at least two years. A DEA inspector may ask to review the biennial inventory during a site inspection.

Review the DEA’s inventory procedures online.

Questions regarding biennial inventories can be directed to the Controlled Substances Program at (650) 723-0448.

Disposal

How do I dispose of controlled substances?

Review the procedure for disposing of controlled substances.

Individual registrants must arrange for the disposal of unwanted or expired controlled substances independently. The following vendor may be able to assist you:

Inmar
48021 Warm Springs Blvd.
Fremont, CA 94539
Telephone: (800) 350-0397
Fax: (510) 933-1470

To have a vendor dispose of your controlled substance waste, you will need DEA Form 41. The University’s Hazardous Waste Program is not allowed to manage controlled substances acquired from individual registrants. However, if there are any questions regarding management of controlled substances waste, EH&S is available for consultation at (650) 723-0448.

Why is it important to maintain custody of controlled substances when I move my lab or leave the University?

If you plan to move to another location at Stanford, it is critical that you ensure that the controlled substances and their records are moved under your supervision, to avoid loss or theft.

If you plan to leave the University, you must make arrangements to move them with you or arrange for their disposal. Abandoning controlled substances may result in criminal penalties. Consult with the DEA office on these matters (see above for contact information).

Loss or theft

How do I report a loss or theft of controlled substances?

If any imminent safety threat exists, contact Public Safety directly at 9-911 or 9-911 (from a University phone).

The DEA provides direction on thefts or significant losses. To report losses or thefts, submit DEA Form 106.

CS Enrollment Form: Controlled Substance Purchase Request Application (CSP Form 1a)

CS Authorized Researcher Application:  SU Controlled Substances Authorized Researcher Application (CSP Form 2)

CS Purchase Request: SU Controlled Substance Re-ordering Request (CSP Form 1b)

CS Usage Log sheet: SU Controlled Substances Usage Log (CSP Form 3)

CS Addition and/or Deletion of Authorized Researcher: Addition or Deletion of Authorized Researchers (CSP Form 1c)

CS Waste Pick-up Request:  SU Controlled Substances Disposal Request Form (CSP Form 6)

CS Recommended Inspection Checklist: Periodic Inspection Controlled Substance Checklist (CSP Form 7)

For questions, please contact EH&S CS Program Office or call (650) 723-0448.

The purchase of precursor chemicals is regulated by the Federal Drug Enforcement Administration (DEA) and the California Department of Justice (CA-DOJ). Precursor chemicals may be procured for the researcher using Stanford’s institutional DEA registration administered by EH&S.

California law requires Stanford to purchase these chemicals from California-based suppliers such as Spectrum Chemical. Note that when purchasing precursor chemicals from California-based vendors, a minimum 21-day holding period is required by California DOJ so plan your purchase request accordingly. For questions, please contact EH&S CS Program Office or call (650) 723-0448.

Purchasing Precursor Chemicals

Any University faculty or senior researcher needing to purchase precursor chemicals for research must submit:

1. Precursor Chemical Purchase Request Application (CSP Form 5) to EH&S. This form describes:
   1. Description of precursor chemical (see Spectrum Chemical)
   2. Signature approval of responsible Faculty/Senior Researcher
   3. Researcher
   4. Account number to charge the department for purchase
2. The application must also include “Statement of intended use” on Departmental letterhead signed and dated by Faculty or Senior Researcher and the authorized researcher. The “Statement of intended use” should:
   1. list the chemical being ordered, the size and number of units,
   2. its intended use and state that the amount ordered will last less than a year, and
   3. its storage location.
3. A Standard Operating Procedure may also be requested during the submittal process.

After processing the Purchase Request Application, EH&S will place the order with Spectrum Chemical. A minimum 21-day holding period by the vendor is required before EH&S receives the shipment. If a specific supplier is identified by the requestor, EH&S will make all possible attempts to fulfill the request and follow-up if the request cannot be met.

The shipment is delivered directly to EH&S and the researcher is notified that the precursor chemicals can be picked up. The researcher will be required to check-in at the EH&S Main Building at 484 Oak Road; show a photo ID and sign the chain of custody logbook. Precursor chemicals must be brought back to the research lab directly after pick-up. Certain precursor chemicals may require EH&S to deliver to the lab and the researcher will be notified before delivery. EH&S will then initiate a journal transfer to charge the PTA for the precursor chemical(s).

Storing precursor chemicals

Precursor chemical storage must follow Stanford University’s chemical storage requirements for the hazard class of the chemical (e.g. flammable Storage Group L or compatible organic bases Storage Group A); see https://ehs.stanford.edu/topic/waste-disposal/handling-storing-waste for details that apply both to stock chemicals and chemical waste.

Tracking inventory

Precursor chemicals must be entered into the online chemical inventory management system (ChemTracker 4). If the precursor chemical will not be replenished in the lab, delete the chemical from the online chemical inventory management system (ChemTracker 4).

Disposal of Precursor Chemicals

Precursor chemicals should be disposed through EH&S Hazardous Waste Program. See Chemical Waste Disposal for more information.