Stanford University

Controlled Substances and Precursor Chemicals

What are controlled substances?

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.

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 mission of the Precursor Chemicals Control Programs is to disrupt the illicit production of controlled substances by preventing diversion of precursor chemicals.

Scope of Program and institutional registration

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 Stanford 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 for the researcher using this institutional registration.

This Program and Stanford University’s institutional registration with the DEA covers Schedule II-V controlled substances regulated by the DEA, precursor chemicals regulated by the DEA and CA-DOJ used in research at the main Stanford campus. See the List of Controlled Substances and Precursor Chemicals for all of these chemicals.

Exclusions

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

  • 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.
  • 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.
  • Use of any Schedule I drug: Faculty and senior research staff must independently obtain individual DEA registrations for any Schedule I drug. Individual registration can be processed by submitting Form 225 to the DEA.
  • Off-campus use of controlled substances and precursor chemicals: 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, Stanford faculty will be subject to the host institution’s controlled substance program. If there is no program, faculty will need to register independently for an individual DEA registration.

Regulations

All individuals and groups associated with Stanford University must comply with with federal and state laws and University procedures governing controlled substances and precursor chemicals. These regulations include:

  • Code of Federal Regulations: Title 21, Chapter II (Parts 1300 to end): These regulations implement the Controlled Substances Act of 1970, the Diversion Control Amendments of 1984, 1985, 1986, 2011, and subsequent amendments.
  • Health and Safety Code Division 10: California Uniform Controlled Substances Act.
Registrations and Purchase Approvals
  1. Enrolling in the University’s registration and purchase approval

    Any University faculty or senior research staff member needing to purchase controlled substances for research under Stanford’s institutional registration must submit to EH&S:

    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.

    It takes approximately three to ten working days to process an application.

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

    Faculty and senior research staff must independently seek authorization from the Research Advisory Panel of California (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.

    Applications are available online, and additional guidance is provided in the SU Controlled Substances Authorized Researcher’s Guide.

    If you already have your own registration with the Drug Enforcement Administration (DEA)

    If you already have your own registration, you don’t have to participate in the University’s program. 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): These regulations implement the Controlled Substances Act of 1970, the Diversion Control Amendments of 1984, 1985, 1986, and subsequent amendments.
    • Health and Safety Code Division 10: California Uniform Controlled Substances Act.

    Registration for work with Schedule I Controlled Substances

    Per CFR 1301.18, faculty and senior research staff must independently obtain individual DEA registrations. Individual registration can be processed by submitting Form 225 to the DEA.

    Registration for work with 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 Hopkins Marine Stanford University – Controlled Substances & Precursor Chemicals Program March 2005 Station), Stanford faculty will be subject to the host institution’s controlled substance program. If there is no program, faculty will need to register independently for an individual DEA registration.

    Complying with the requirements of the University’s Controlled Substances and Precursor Chemical Program

    Failure to comply with the authorization, storage, security, inventory, and record-keeping 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.


Researcher Authorization and Security
  1. 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 and Precursor Chemicals Program. All faculty, staff, and students intending to conduct research using controlled substances must complete the Authorized Researcher Application. This form is then sent to EH&S’s Controlled Substances Program Office.

    Reporting 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.

    If the controlled substances are stolen or diverted, the information will be forwarded to Stanford’s Office of Public Safety. The University’s Program then will submit the required loss/theft reports directly to the DEA. If any imminent safety threat exists, contact Public Safety directly at 9-911.

    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.

    Reporting drug diversion

    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.

    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 feasible to allow an employee to work in a drug security area.


Management Responsibilities
  1. EH&S manages the institutional program which:

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

    Participating faculty and senior research staff

    Participating faculty and senior research staff are those staff who have enrolled under the University’s Program for research involving the use Schedule II-V controlled substances. Enrolling involves seeking EH&S’s approval and submitting the Controlled Substance Purchase Request Application and Controlled Substance Authorized Researcher Application, along with a “Start-up Lab Inspection.”

    In order for Stanford to ensure compliance and maintain its institutional DEA registration, it is critical that participating faculty and senior research staff clearly understand their responsibilities, which are to:

    • Comply with University, federal, and state regulations pertaining to the possession of controlled substances by adhering to Stanford University’s Controlled Substances and Precursor Chemicals Program
    • Maintain strict control over inventory and security for controlled substances
    • Ensure that controlled substances are not intermingled in any manner (e.g. usage, storage, etc.) with those controlled substances owned by other individual(s) or other sources
    • Ensure that Schedule II controlled substance inventory and records are maintained separately from Schedule III-V controlled substances
    • Apply for authorization from the Research Advisory Panel of California (RAPC) if research involves Schedule I Controlled Substances, Human Research (involving Schedule I or II Controlled Substances), or drug abuse treatment research
    • Ensure necessary researcher authorization for individuals in the laboratory who are assigned to work with controlled substances (e.g. staff, graduate students, post-docs, visiting scholars, or co-faculty) and maintain documentation to verify currently authorized researchers
    • Take the online Controlled Substances Training (EHS-2125-WEB) available via STARS and ensure that authorized researchers complete this training
    • Provide training to authorized researchers on laboratory-specific operations involving controlled substances and precursor chemicals; provide information on the health hazards of the substances, including local and systemic toxicity and the conditions and situations that could result in exposure; and retain training records for at least one year
    • Ensure authorized researchers receive, store, use, dispose of, and continually maintain usage log sheets and the online chemical inventory management system for controlled substances, per the University’s Program
    • Maintain usage logs for two years after the full use or disposal of controlled substances
    • Ensure that periodic self-inspections are conducted at least quarterly, using the Periodic Inspection Controlled Substance Checklist (Form 7)
    • Retain inspection records for at least one year
    • Assign more than one authorized researcher to conduct self-inspections
    • Complete and submit to EH&S the physical inventory biennially, as required by regulations
    • Contact the Controlled Substances Program Office for approval prior to moving the storage location of controlled susbtances
    • Immediately report missing controlled substances to EH&S by calling 5-9999 (EH&S will forward cases of suspected theft or diversion to Stanford’s Department of Public Safety. Any imminent safety threats are to be reported to Public Safety at 9-911.)
    • Ensure that any delegated duties associated with this program are conducted in a timely manner

    Authorized researchers

    Authorized researchers are individuals (e.g. staff, graduate students, undergraduate students, post-docs, visiting scholars, and co-faculty) who are assigned by the participating faculty or senior research staff to work with controlled substances within their laboratory, and who have submitted the Controlled Substance Authorized Researcher Application to EH&S.

    An authorized researcher is responsible for:

    • Complying with University, federal, and state regulations pertaining to the possession of controlled substances by adhering to Stanford University’s Controlled Substances and Precursor Chemicals Program regarding:
      • Authorization
      • Training
      • Security, receipt, storage, use and maintenance of usage log sheets, disposing of controlled substances
      • Separately maintaining Schedule II controlled substance inventory and records from Schedule III-V controlled substances
      • Reporting theft or loss of controlled substances
    • Taking the online Controlled Substances Training

    • Participating in or conducting program activities such as maintaining online inventory, periodic inspections, biennial campus-wide inventory, etc., if delegated by participating faculty or senior research staff

Controlled Substance Management
  1. Use authorization and purchasing

    Any faculty or senior research staff member needing to purchase Schedule II-V Controlled Substances for research under Stanford’s institutional registration must gain EH&S use/purchasing approval.

    1. For use/purchasing approval, submit the following forms to EH&S:
    2. After receipt and approval of both forms, EH&S will coordinate with the authorized researchers to conduct an inspection of the laboratory to verify that security, storage, training, recordkeeping requirements are met.
    3. When re-ordering controlled substances within two years of the original use/purchase approval, submit the SU Controlled Substance Re-Ordering Request (Form 1b) to EH&S. After validating any purchase or re-ordering request, EH&S is to notify the requestor of approval/purchasing status and inform them of their Controlled Substance Authorization (CSA) number for this order. 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. EH&S will then initiate a journal transfer to charge the department for the Controlled Substance.

    SU Controlled Substance Purchase Request Application (Form 1a)*

    This form identifies the controlled substances requested and the names of the authorized researchers, and 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 (or the applicant’s supervisor, if the applicant is the department chairperson or higher)

    Note that this process does not cover authorization requirements of the Research Advisory Panel of California (RAPC).

    Faculty and senior research staff 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. Applications are available online.

    * For Schedule II requests, submit a separate Form 1a. Records for Schedule II Controlled Substances must be maintained separately from Schedule III-V records.

    SU Controlled Substance Authorized Researcher Application (Form 2)

    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
    • Obtain the requisite health and safety training from his or her supervisor on the hazards of working with the controlled substance
    • Follow listed work practices, as further detailed in the User’s Guide & Written Program

    Central receiving and dispensing process

    All authorized controlled substance purchases are delivered to the EH&S’s Controlled Substances and Precursor Chemicals Program Office, located on-campus at the Environmental Safety Facility at 480 Oak Road.

    Once shipment is received, EH&S notifies the faculty or senior research staff member, or an authorized designate, that material can be picked up at EH&S. Only Stanford Controlled Substance authorized researchers with Stanford ID (or other acceptable form of picture ID) will be allowed to pick up orders and sign the chain of custody statement. EH&S will maintain documentation of all approved distributions. Authorized researchers must deliver the order directly to the approved storage location specifically listed on the submitted SU Controlled Substance Purchase Request Application.

    Inventory and recordkeeping

    Per the Code of Federal Regulations (Title 21, Section 1304), complete and accurate records shall be kept of all controlled substances purchased, manufactured, transferred, or wasted.

    For authorized researchers: Controlled Substance Logbooks

    Each authorized faculty or senior research staff member must maintain an up-to-date, legible usage log of each controlled substance in possession using the SU Controlled Substances Usage Log (Form 3). Records must be kept locally for at least two years from the final use of the controlled substance. Logbooks shall be kept available for periodic audit by EH&S and the DEA.

    For authorized researchers: Biennial inventory submission

    On a periodic two-year institutional cycle, each faculty or senior research staff member must submit a controlled substance inventory on a particular day in January to EH&Sm using the SU Controlled Substances Biennial Inventory Form (Form 4). Submit a separate form for Schedule II controlled substance inventory.

    For EH&S: Institutional inventory tracking

    Upon initial registration with the DEA, EH&S has generated an initial campus-wide inventory of all reported stocks of controlled substances being covered under the University’s institutional registration.

    Every subsequent two years, the University shall inventory each substance during a one-day institutional inventory, in which participating faculty and senior research staff must complete the SU Controlled Substances Biennial Inventory Form. From these records, it must be possible to trace the flow of any drug from the vendor to the dispensing station (EH&S), to the end of use by the authorized research staff. Inventory records are to be maintained for at least two years from final use of the controlled substance.

    Storage and security

    • The University’s overall security system involves a coordinated system of physical and administrative controls.
    • Stanford University’s Department of Public Safety has officers who continuously patrol the University and enforce public safety and security.
    • 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.
    • Controlled substances shall be stored in a securely locked, substantially constructed cabinet, located where access is limited. (Note that carfentanil, etorpine hydrochloride, and diprennorphine must be stored in a safe.)
    • 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.
    • All researchers intending to handle controlled substances, including faculty and senior research staff, are required to undergo background screening via submission of the SU Controlled Substance Authorized Researcher Application (Form 2).
    • 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.
    • 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 substance is converted or diluted, the new container must be labeled properly.

    Loss or theft

    Any detected loss or theft of controlled substances must be reported immediately to Stanford University’s EH&S Emergency Line at 5-9999. If the material 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 9-911. EH&S will submit the required loss/theft reports directly to the DEA.

    Transfers

    Intra-campus transfers:

    Ownership of controlled substances may only be transferred to an individual covered under the University’s Program, and such transfer may only occur with specific written approval, granted by EH&S.

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

    • The original inventory must have been acquired under the Stanford DEA registration.
    • The faculty or senior research staff member receiving the substance(s) must submit a SU Controlled Substance Purchase Request Application to EH&S and receive approval from EH&S for such transfer.
    • Both parties must maintain documentation of any approved transfer.

    Prohibition of inter-campus transfers:

    Under no circumstances can controlled substances falling under the institutional registration be transferred into or out of the University campus. 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. 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. Request a pickup from EH&S’s Hazardous Waste Program by submitting the SU Controlled Substances Disposal Request Form (Form 6) via fax to x5-3468.

    Categories of waste

    • Wasted controlled substances: These include items such as unused tablets, injections, oral liquid, or preparations compounded in error, which contain controlled substances.
    • Expired controlled substances: These include controlled substances which have exceeded their shelf life, unwanted controlled substances classified as non-formulary drugs, 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.


Precursor Chemical Management
  1. The mission of the Precursor Chemicals Control Programs is to disrupt the illicit production of controlled substances by preventing diversion of chemicals used to make drugs. The illegal production of drugs such as methamphetamine, cocaine, heroin, and MDMA (ecstasy) requires enormous quantities of precursor and essential chemicals. These federal and state programs seek to minimize the regulatory burden on the legitimate chemical industry, while instituting effective anti-diversion policies.

    A Drug Enforcement Agency (DEA) registration (or California Department of Justice registration) is required to purchase precursor chemicals from vendors outside of California. If precursor chemicals are bought from a vendor within California, registration may not be required. Note that when purchasing precursor chemicals from California-based vendors, a minimum 21-day hold processing period is required.

    Review the List of Controlled Substances and Precursor Chemicals.

    Approval and purchase process – use of institutional DEA registration

    Any University faculty or senior research staff member needing to purchase precursor chemicals for research must submit the Precursor Chemical Purchase Request Application to EH&S to initiate the approval process. A statement of intended use may be required.

    After approving the Purchase Request Application, EH&S will place the order using a pre-selected vendor. 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, where the authorized researcher is notified that the package can be picked up. Precursor chemicals must be delivered to the research lab directly after pick-up. EH&S will then initiate a journal transfer to charge the department for the precursor chemical.


Storing, Transferring, Inventorying & Disposing
  1. Storing controlled substances

    Controlled substances shall be stored in a securely locked, substantially constructed cabinet, located where access is limited.

    As an exception, note that carfentanil etorphine hydrochloride and diprennorphine must be stored in a safe.

    Storing precursor chemicals

    Precursor chemicals’ storage must follow Stanford University’s chemical storage requirements for the hazard class of the chemical (e.g. flammable or toxic).

    An intra-campus transfer of a controlled substance will be approved by EH&S if the following criteria are met:

    • The original inventory must have been acquired under the Stanford DEA registration.
    • The faculty or senior research staff member receiving the substance(s) must submit a Controlled Substance Purchase Request Application (Form 1a) to EH&S and receive approval from EH&S for such transfer.
    • Both parties must maintain documentation of any approved transfer.

    Transferring controlled substances

    To another individual at another University or institution

    Under no circumstances can controlled substances falling under Stanford’s institutional registration be transferred off or onto the main campus.

    Moving controlled substances between Stanford University and VAPAHSC

    Faculty with dual appointments at Stanford University and the VA Palo Alto Health Care System (VAPAHSC) 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.”

    Tracking inventory

    Controlled Substance Usage Logs

    Each authorized faculty or senior research staff member must maintain an up-to-date inventory of each controlled substance in possession using the SU Controlled Substances Usage Log (Form 3). Records must be kept locally for a minimum of two years after the final use of the controlled substance. The usage log shall be readily available for periodic audit by EH&S and the DEA.

    The biennial campus-wide inventory

    Per CFR 1304.11(b), the University must inventory each substance during a one-day institutional inventory, in which participating faculty and senior research staff must complete the Controlled Substances Biennial Inventory Form (Form 4) every two years. From these records, it must be possible to trace the flow of any drug from the vendor to the dispensing station (EH&S) to the end of use by the authorized research staff. Inventory records should be maintained for at least two years.

    Disposing of controlled substances and precursor chemicals

    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’s Hazardous Waste Program. Participants of the University’s Controlled Substances Program are to request waste pick-up from the Hazardous Waste Program by submitting the SU Controlled Substances Disposal Request Form (Form 6) via fax to x5-3468.

    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.


Schedules of Controlled Substances
  1. The Federal Drug Enforcement Administration (DEA) divides controlled substances into five schedules. These drugs are listed in the Controlled Substances Act (CSA) of 1970. Examples of drugs in each schedule can be found in the List of Controlled Substances and Precursor Chemicals, though this is not a complete listing (use the included hyperlinks for drugs that are not listed).

    Section 812 of the CSA lists substances that were controlled when the law was enacted. Since then, approximately 160 substances have been added, removed, or transferred from one schedule to another. The current official list of controlled substances can be found in section 1308 of the most recent issue of Title 21 Code of Federal Regulations (CFR), Part 1300 to end (21 CFR §1308), and the final rules published in the Federal Register after the issuance of the CFR.

    This list describes the basic or parent chemical, but doesn’t describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may be controlled substances. These lists are intended as general references, and are not comprehensive listings of all controlled substances. Please note that a substance need not be listed as a controlled substance to be treated as a Schedule I substance for criminal prosecution. A controlled substance analogue is a substance that is intended for human consumption and is structurally or pharmacologically substantially similar to, or is represented as being similar to, a Schedule I or Schedule II substance, and is not an approved medication in the United States.


FAQs about Controlled Substances
  1. General

    What are controlled substances?

    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.

    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 mission of the Precursor Chemicals Control Programs is to disrupt the illicit production of controlled substances by preventing diversion of precursor chemicals.

    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:

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

    Any University faculty or senior research staff member needing to purchase controlled substances for research under Stanford’s Institutional Registration must submit to EH&S:

    • The SU Controlled Substance Purchase Request Application (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:
      • The Administrative Panel for Laboratory Animal Care (APLAC) for animal research
      • The Institutional Review Board (IRB) for human subjects-related research
      • The applicant’s department chairperson
    • The SU Controlled Substance Authorized Researcher Application (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 or precursor chemical purchase request application?

    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 senior research staff 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. Additional guidance is provided in the SU Controlled Substances Authorized Researcher’s Guide.

    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 senior research staff must independently obtain individual DEA registrations. Individual registration can be processed by submitting Form 225 to the DEA.

    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 substance 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 and  Precursor Chemical 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 of its Controlled Substances and Precursor Chemicals Program.

    All faculty, staff, and students intending to conduct research using controlled substances are required to complete the Authorized Researcher Application. This form must be sent to EH&S’s Controlled Substances Program Office and then forwarded 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. If the controlled substances are stolen or diverted, the information will be forwarded to Stanford University’s Office 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 9-911.

    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 and/or precursor chemicals, 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 5-9999. 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 drug security area.

    Storing, transferring, inventorying, and disposing

    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 carfentanil etorphine hydrochloride and diprennorphine must be stored in a safe.

    How do I store precursor chemicals?

    Precursor chemicals’ storage must follow Stanford University’s chemical storage requirements for the hazard class of the chemical (e.g. flammable or toxic).

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

    Yes. An intra-campus transfer of a controlled substance will be approved by EH&S if the following criteria are met:

    • The original inventory must have been acquired under the Stanford DEA registration.
    • The faculty or senior research staff member receiving the substance(s) must submit a Controlled Substance Purchase Request Application (Form 1a) 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 falling under Stanford’s institutional registration be transferred off or onto the main campus.

    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 Logbooks?

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

    What is the biennial campus-wide inventory?

    Per CFR 1304.11(b), the University must inventory each substance during a one-day institutional inventory, in which participating faculty and senior research staff must complete the Controlled Substances Biennial Inventory Form (Form 4) every 2 years. From these records, it must be possible to trace the flow of any drug from the vendor to the dispensing station (EH&S), to the end of use by the authorized research staff. Inventory records should be maintained for at least two years.

    How do I dispose of controlled substances and precursor chemicals?

    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’s Hazardous Waste Program. Participants of the University’s Controlled Substances Program are to request waste pick-up from the Hazardous Waste Program by submitting the Controlled Substances Disposal Request Form (Form 6) via fax to x5-3468. For disposal of precursor chemical waste, requests are to be made online.

    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.


DEA Research Registration FAQs
  1. 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.

    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 is:

    SAN JOSE RESIDENT OFFICE
    One North First Street, Suite 405
    San Jose, CA 95113

    Diversion Number: (408) 291-2631
    Diversion Fax: (408) 291-2636
    Group Supervisor: Rikhart Rupnik: (408) 291-2631

    Stanford University’s Controlled Substances Program is also available for consultation on compliance requirements for individual registrants. Call EH&S at (650) 723-0448.

    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 and Precursor Chemicals.

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

    • Research off of 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 CFR1301.90-93.

    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 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 in picking up your unwanted or expired controlled substance waste:

    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.

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



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