The purpose of the Committee is to:

• Establish and review policies and procedures on all matters relating to the purchase, storage, usage, and disposal of controlled substances by members of the University Research community,
• Review and authorize UVM Researchers’ requests to purchase and use controlled substances in research and education. Researchers are prohibited from purchasing and using controlled substances without this authorization,
• Develop standards for monitoring compliance and responding to non-compliance with regulations and/or institutional procedures.

The following policies provide requirements for the use of controlled substances associated with animal research, the administration of controlled substances to human subjects as part of a research protocol, and when using controlled substances for in vitro or analytical research. These policies do not apply to controlled substances administered or dispensed to a patient by a licensed practitioner in the course of professional medical, dental, or veterinary practice.

Back To Top

The University is committed to ensuring safety and compliance with federal and state regulations pertaining to controlled substances in the research setting. This Committee is established to review policies and procedures and provide oversight for compliance in conducting safe research with controlled substances. Three primary resources are listed below:

• DEA Researcher’s Manual – An Informational Outline of the Controlled Substances Act
• Title 21 United States Code (USC) Controlled Substance Act (link is external) U.S. Department of Justice - Drug Enforcement Administration (DEA) outline of the federal Controlled Substance Act
• Title 21 Code of Federal Regulations, Part 1300-End (link is external) Index listing the links to the sections of DEA policy for controlled substance registration.

Back To Top

The Committee is established by authority of the University’s Vice President for Research (“VPR”), pursuant to the University’s Controlled Substances in Research UOP, (link) in order to oversee compliance with federal and state regulations governing the use of controlled substances.

The Committee is delegated the authority by the Vice President for Research to:

• Define the policies, procedures, guidelines, and standards governing the use of controlled substances at the University.
• Define the basic policies, procedures and standards by which research and instructional protocols using controlled substances will be reviewed;
• Review requests and render determinations regarding the use of controlled substances for research and educational purposes; approval to use controlled substances, despite institutional approvals, is contingent upon DEA registration and ongoing compliance with DEA regulations;
  • (Note: Controlled substances registered through a pharmacy or hospital, are not subject to UVM Controlled Substance Committee approval).
• Monitor the use, storage and access control of controlled substances and require inventory reports from investigators;
• Terminate the authority to use controlled substances at UVM;
• Respond to observations of non-compliance and recommend corrective actions to appropriate personnel including Department Chair, Dean, Vice President for Research, UVM Police, Office of General Counsel and/or U.S. DEA.

The Vice President for Research shall have the final authority to disapprove, restrict, or terminate the use of controlled substances by a UVM researcher.

• The CSC will present to the VPR information pertaining to compliance monitoring along with recommendations as needed.

Back To Top

Committee Chair

It is the responsibility of the Committee Chair to:

• Conduct Committee meetings in accordance with established federal and state regulations and University operating policies and procedures
• Sign official Committee action documents
• Keep abreast of relevant federal and state regulations
• Contact the Vice President for Research with an appraisal of the Controlled Substance Committee’s prior year’s performance
• Recommend new Committee members to the Vice President for Research
• Ensure that new committee members are properly oriented to and educated about their duties and responsibilities
• Initiate activities designed to assist investigators

Appointment

The Chair must:

• be an employee of the University
• be an approved controlled substance registrant at the University
• be appointment by the Vice President for Research or their delegate

The term of appointment to the Chair shall be three years and is renewable.

Vice-Chair

A Vice-Chair is nominated by the Chair from among Membership of the CSC.

• The Vice Chair must meet the qualifications set forth in the CSC Policies and Procedures
• The term of appointment for the Vice-Chair shall be three years and is renewable.

Administrative Support

Responsibilities include:

• Coordinate and conduct the administrative and clerical work of the Committee
• Serve as liaison with appropriate University administrative offices, project investigators, other institutional safety and ethics boards, and various regulatory agencies
• Assist University administrators in the preparation of federal and state reports

Back To Top

General criteria for membership

• Members shall be of varying professional backgrounds and shall demonstrate a genuine interest in, and commitment to, the purpose of the Committee.  The membership will be sufficiently qualified through the experience and expertise of its members and the diversity of its members, including consideration of race, gender, and cultural backgrounds.

Method of Appointment

• All members shall be appointed by the Vice President for Research or their delegate.
• When vacancies occur, nominations will be sought from Committee members, after which written formal recommendation(s) for the new member(s) shall be made, by the Committee Chair, to the Vice President for Research or delegate.
• The Vice President for Research or delegate shall in no case make an appointment without consulting the Committee Chair.

Term of Appointment

• Committee appointments shall normally be for three-year terms and are renewable.

Membership of the Committee

• The Committee will be comprised of 7 members.
• The ex officio members of the Committee shall include the following:
  • a representative from the Research Protections Office
  • a representative from the Office of the Vice President for Research
  • a representative of the Department of Risk Management & Safety
• The Committee Chair, Vice Chair, and remainder of the membership will be determined from the roster of active authorized users of controlled substances as follows:
  • the University Veterinarian from the Office of Animal Care Management.
  • one tenure-track faculty representative from the Larner College of Medicine.
  • two other tenure-track faculty representatives whose backgrounds and perspectives will help ensure a well-rounded and objective Committee. Preferably, at least one of these will represent other colleges at UVM.
• Members who miss two (2) consecutive meetings may be asked to resign from the Committee.

Remuneration

• Appointment to the Committee shall be without monetary compensation.

Liability

• UVM carries Crime Insurance that would indemnify UVM for employee or officer theft, computer fraud, funds transfer fraud, forgery and other criminal acts, in an amount of $5,000,000 per claim (and annual limit). Committee members are indemnified under UVM’s commercial general liability insurance, and errors and omissions insurance while carrying out their duties for the university.  If committee members are sued during the good faith performance of their duties, the University's insurance provides legal counsel and indemnification (protection against possible damage or lawsuit in accordance with UVM’s Indemnification policy. See https://www.uvm.edu/sites/default/files/UVM-Policies/policies/indem.pdf.)

Back To Top

Authorized User. Each registrant must designate and document those individuals who will be given authority to access and use controlled substances.

Controlled Substances (CS). Compounds containing any quantity of substances with a stimulant, depressant, or hallucinogenic effect on the higher functions of the central nervous system, and have the tendency to promote abuse or physiological or psychological dependence, as designated under the Controlled Substance Act

Controlled Substances Committee (CSC). Established by the Vice President for Research, the CSC reviews applications from UVM researchers who have valid DEA registrations, and may grant authority for them to purchase and use controlled substances in research at UVM. The CSC reviews policies and procedures regarding controlled substances, develops tools to assist researchers to comply with requirements, and develops standards for inspection, compliance monitoring, and responses to non-compliance. Any employee of the University utilizing controlled substances for research must apply for authorization with this committee and undergo a review of plans to meet regulatory requirements.

Controlled Substance Schedule. The drugs and substances covered under the Controlled Substance Act are organized into five schedules. The DEA Website maintains a current schedule of which substances are controlled as well as their classification. Schedules are codified in 21 CFR§1308.

Schedule I: No accepted medical use.

• Schedule I compounds are classified as illicit drugs along with their chemical precursors.
• The DEA requires a Schedule I registration application for use of these substances.

Schedules II-V: Accepted medical uses.

• Schedule II substances have a high potential for abuse with severe psychological or physical dependence.
• Schedule III-V substances have a lower potential for abuse than substances in Schedules I or II.

Drug Enforcement Administration (DEA). Federal department that regulates the use of substances that have a high potential for diversion or abuse. DEA regulations are codified in 21 CFR§1300.

DEA Registrant (the Registrant). A person who holds a DEA Registration and who is responsible for the use, security, and disposal of controlled substances in accordance with DEA regulations. The DEA registrant is responsible for maintaining a list of authorized users, limiting access to the CS, and for ensuring all security measures. The Registrant is solely responsible for the controlled substance from receipt to destruction.

DEA Registration. DEA registration grants practitioners (defined as physicians, dentists, veterinarians, pharmacies, or hospitals), researchers, and others, federal authority to handle controlled substances in the course of processional practice.

Back To Top

The Committee, with support from Risk Management and Safety (RMS) and the OVPR, will develop a complete and uniform set of standard operating policies and procedures. These operating policies and procedures shall be developed and updated as necessary to ensure compliance with all relevant federal and state regulations governing controlled substances.

All policies and procedures will be designed to ensure that the Committee review of controlled substance use in research is conducted with thoroughness, consistency and objectivity; in a manner that allows each member to exercise independent judgment; with proper balance of professional expertise.

Meetings

The CSC meets quarterly when there are agenda items.

Meeting Notices

The agenda, including the time and location of the meeting, is distributed in advance to all members. All pre-meeting materials for registrations are located within the electronic system.

Required Agenda Items

• New Requests for Use of Controlled Substances as applicable
• Inspection Findings
• Compliance Issues and Corrective Actions
• Other Items as Applicable

Minutes

Minutes will be maintained as a PDF in UVMClick system.  Minutes must include: the date of the meeting, members present, members absent, and a summary of deliberations, recommendations, actions, and reviews.

Conducting Initial and Continuing Review

Most initial reviews will be conducted via designated member review. At the discretion of the designated reviewer, a registration will be brought to the Full committee for review. If reviewed in a Full convened meeting, the official Committee action to approve or disapprove an individual investigator’s use of controlled substances in research shall be voted on, in person or virtually, with the results and any discussion being entered into the minutes. No Committee members shall be assigned to review or shall vote on any activity in which they have a conflicting interest.

Continuing reviews will be conducted by CSC subsequent to receipt of an appropriate progress report from the investigator.  Reviewer forms and internal checklists are utilized as a guide to ensure that these criteria have been met. All continuing reviews will be conducted using the designated member review process unless the reviewer requests for review at a Full convened meeting.

Review Decisions and Process for Appeal

Review decisions will be forwarded to the researcher in writing.   Review decisions may not be overridden.  However, the Vice President for Research Administration shall have the final authority to disapprove, restrict or terminate a study which has received CSC approval. There is no process delineated for appeal of Committee decisions. However, there is no prohibition for resubmission of specific requests for additional review by the Committee.

Registrations Requiring More Frequent Review

Determination of which registrations require review more often than annually is done at the time of registration review, on a case by case basis, depending upon specific factors, including, but not limited to, the level of risk.

Modification to a CSC Registration

The CSC requires that changes in approved use of controlled substances be reviewed prior to initiation.  Changes implemented prior to committee approval is considered noncompliance. 

Removal from Consideration

RPO staff will have the authority to remove from further Committee consideration, a registration which has obtained initial approval, when the PI fails to respond to ongoing clarifications or training requests. The PI will be required to close the registration in UVMClick.

Documentation

The CSC, through the administrative staff, is responsible for reporting findings, actions as well as requesting clarifications to the investigators in writing, and to the appropriate offices within the institutions’ administration through reports and meeting minutes to institutional officials through their representatives on the Committee, if so required.

Authority to Sign CSC Documents

a. Results of Reviews, Actions and Decisions whether Full or Designated Member Review

Depending upon the nature of the required conditions, the CSC designates any of the following individuals or groups of individuals to determine that the conditions of approval have been satisfied:

• The CSC chair;
• Another member;
• CSC Analyst/Member or;
• Other qualified CSC administrative staff person, who need not be an CSC member.

b. Administrative Review and Approval

Administrative items are reviewed and approved by Analysts/Members or appropriate CSC staff. CSC Analysts/Members may consult with the Committee chair prior to approval. Below are examples of administrative items.

• Changes to Key Personnel
• Continuing Reviews

c. Routine Internal Correspondence

Any action, letter, memo or e-mail between the Committee or CSC staff and the faculty or staff of the University that provides information concerning the review of CS use by the Committee or CSC staff and which do not imply or appear to imply approval of this activity may be signed by the staff member.

d. Decisions Made by the Chair

Any letters, memos or email sent representing the decision or opinions of the Chair or Vice Chair of the CSC, as long as such correspondence does not imply review and approval, may be signed by CSC staff if so designated by the CSC.

Electronic Reviews

All reviews, initial, continuing reviews and modifications are completed electronically by the CSC members as assigned. Members receive an email notice that a review is pending. Members are required to authenticate into the electronic system using their UVM NetID and password prior to completing their review. The system validates the member’s authentication credentials based upon the member’s role in the system and determines available actions for each person. The electronic review is stamped within the system with the name of the individual carrying out the review activity (electronic signature), and the time and date that the electronic signature was applied to the review.

Members only access records that they have been assigned to review.

Voting

• A majority of the total number of regular voting members will constitute a quorum.  The number in attendance must be one more than half the total number of regular voting members. If a quorum is lost at any time during the meeting, the meeting shall be adjourned and no further action taken until a quorum is attained.
• All meetings will be conducted using Robert’s Rules of Order as guidance, with deviations made as deemed appropriate by the Chair.
• If a CSC member has a conflicting interest in a review (including, but not limited to being a registrant) that member may only provide information as requested by the CSC and will not be assigned to officially review nor vote on that registration.
• CSC members may participate in a convened meeting via telephone or video conferencing.  Those members have access to the research protocol materials in advance of the meeting within UVMClick.

Record Requirements

The CS keeps all records in accordance with all pertinent regulations and local policies. This record keeping includes the following.

Membership rosters - The institution is required to maintain a current list of CSC members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to CSC deliberations. UVM rosters indicate regular voting versus alternate members, as well as alternate replacement assignments. Rosters are updated each time there is a change in the Committee membership.

Written procedures and guidelines including, but not limited to, the Policies and Procedures Manual and all website content.

Minutes of meetings document

• attendance of members, consultants, and guests’ discussion of controverted issues,
• actions taken,
• basis for requiring changes in research or disapproving CS use,
• a record of voting (for, opposed, abstaining, recusal),
• members arriving and leaving the meeting once the meeting is called to order,
• names of members who recuse themselves because of a conflict of interest along with the fact that a conflict is the reason for the recusal,
• which alternate member is replacing a primary member,
• a record and vote of members who participated in the convened meeting via phone or video conferencing.

A report of business conducted by the designated review process is available in the UVMClick system.

Communications to and from the CSC are maintained in the registration record.

Bylaws Revision

Policies may be revised by a majority vote of Committee members at a duly warned Committee meeting.

Back To Top

Researchers must apply for and obtain authorization from UVM Controlled Substance Committee (CSC) to purchase, store and use CS. The CSC has the authority to approve, require modifications in (to secure approval), or disapprove all use of controlled substances. These review categories are employed for new registrations, amendments to existing registrations, and continuing reviews. 

Preliminary Reviews

In all cases, there is at least one preliminary review that require completion prior to review by the Committee. 

CSC Analyst Pre-Review

The CSC must receive sufficient information regarding proposed activities to make the determinations as required by regulations.  the Analyst will conduct a pre-review of submitted materials.  A new registration or amendment will not be added to an agenda until this review has been completed.    A pre-review checklist is followed to determine if the submission is ready for review. If the submission is incomplete or lacks information necessary to conduct a review, it will not be reviewed until the information is provided.  Once determined to be satisfactory the review will continue.

Committee Review (convened meeting)

The CSC employs the convened meeting review process for review and approval of submissions that have been requested for full review. Submissions default to designated review method and may be called to full at the designated member reviewer’s discretion.

Notification to Research Community
Committee meetings are noticed on the RPO website. Submissions are added to an Agenda after the CSC Analyst pre-reviews are complete.

Notification to the Committee
Distribution of the Agenda to all members occurs approximately 1 week in advance of the convened meeting.   All new registrations, amendments, incidents and other business requiring full committee action are placed on the agenda for discussion.

Access to the Materials
Committee members have access to all the registration materials through the electronic submission and review system.

Reviewer Assignments
One or two reviewers are assigned by the RPO Analyst to review the submission and all provided materials.  The reviewers summarize the proposed activities for the full Committee at a convened meeting and answer questions during the discussion.  An approval memo or a request for further clarification will be sent to the principal investigator.

Designated Member Review
A new registration or amendment to an existing registration may be reviewed by a designated member of the CSC.

Assigning Reviewers
The submission will be assigned to a designated member for review once CSC Analyst pre-review is complete. 

Back To Top

Animal Use (IACUC)
Review by the CSC is independent of the review by the IACUC.  However, there is coordination regarding use of controlled substances in animal studies between both committees.  Approval to purchase and use controlled substances is contingent upon the completion of and approval of IACUC process.

Human Subjects (IRB)
Review by the CSC is independent of the review by the IRB. However, there is coordination regarding the use of controlled substances in animal studies between both committees.  Approval to purchase and use controlled substances is contingent upon the completion of and approval of IACUC process.

UVM Purchasing Services Department

UVM prohibits the use of purchasing cards to purchase controlled substances and only allows purchase through a purchase order (PO).  Acquisition of a PO is done by creating a requisition with the Purchasing Services Department.

Back To Top

The CSC shall review and have authority to approve, require modifications (to secure approval), or disapprove use of controlled substances covered by this policy.

APPROVED

This decision indicates that the initial review of a registration at a convened meeting or via designated review has been approved without requiring either further (a) changes to the registration or (b) submission of clarifications or additional documents.

CLARIFICATIONS REQUESTED FOR INITIAL APPROVAL

This decision indicates approval is pending satisfactory resolution of conditions or clarifications that the CSC requires to approve the registration. Under this scenario, for full review of a registration, further review by the full CSC at a subsequent convened meeting is not necessary to secure final approval.

The designated review process is employed to review the response from the investigator. The CSC directs that the designated reviewer review and determine on behalf of the CSC whether the changes, clarifications, and/or additional documents to be submitted by the investigator(s) are satisfactory.

If under the designated review of the response, the designated reviewer is unable to approve the registration because he/she cannot make the determinations required for approval, they can either refer the project to the CSC for further review and action at a convened meeting, or defer approval of the registration and require that the investigator (a) make changes to the registration, or (b) submit clarifications or additional documents prior to further review by the designated member reviewer.

DEFERRED (tabled)

This action is taken under full Committee review any time the CSC cannot make one or more of the determinations required for approval but with major revisions may be found to be approvable. When deferring a project, the CSC, under its authority to require modifications in order for an investigator to secure approval, may require that the investigator (a) make changes to the registration or (b) submit clarifications or additional documents.  The use of controlled substances may not proceed until the CSC reviews, at a subsequent convened meeting, the revised registration and approves it.

DISAPPROVED

This action is taken under full Committee review when the determinations required for approval of the use of controlled substances cannot be made, even with substantive clarifications or modifications to the registration. If the CSC decides to withhold approval of a registration, it will include in its written notification a statement of the reasons for its decision.

The above review determinations also apply to follow on submissions to an approved registration including amendments and continuing reviews. 

SUSPENSIONS OR TERMINATIONS

A suspension or termination of CSC approval is a directive of the CSC, either to stop temporarily some or all previously approved use of controlled substances activities, or to stop permanently some or all previously approved use of controlled substances. All suspensions or terminations are immediately reportable to federal agencies.

The RPO or VPR have the authority to suspend or terminate previously approved use of controlled substances when required for the urgent protection of personnel and/or the environment and insufficient time exists for the convened CSC to review the issue. Any suspension of use of controlled substances by the above individuals is placed on the next available agenda of a meeting of the full CSC.  The convened CSC will review the circumstances that led to the suspension and will make the determination to uphold or overturn the suspension. The CSC will recommend corrective actions if the suspension is upheld.

Back To Top

Researchers conducting protocols that use controlled substances must have their own DEA registration and a separate registration is required for each location where the CS is being used. Researchers are prohibited from ordering CS for other researchers’ protocols. Researchers obtain a DEA Registration using appropriate DEA forms and procedures available at www.deadiversion.usdoj.gov . Key personnel who are given access to CS must be listed as authorized users at the time of DEA registration application. At time of initial DEA screening, DEA conducts a required background check on both the registrant and anyone listed as authorized users on the registration. Registrants are responsible for registration, costs, requesting approval for changes in approved protocol, and applying for renewals in accordance with 21 CFR§1301.18.

Licensed practitioners

Licensed practitioners must register with the DEA for a separate research registration; however, they should use their Vermont license information when requesting a DEA registration for the purpose of doing research. This reduces the risk to medical or dental practice registrations in the event of noncompliance with research regulatory requirements by state and federal agencies. Vermont is a one license requirement state, meaning that individuals who already possess a state practitioner license (i.e., physicians, veterinarians, dentists) and who wish to also use controlled substances for research can use their state license to apply for a DEA registration.

Non-licensed researchers

The Vermont Office of Professional Regulation has waived the Vermont State Board of Pharmacy license requirement for UVM research faculty and individual investigators that do not have a state practitioner’s license. With this exemption, non-licensed researchers may apply directly for a DEA registration.

Back To Top

Once a registration has been approved, the registrant (PI) has the responsibility of informing the CSC of changes in PI, authorized user, reporting incidents, submitting an annual continuing review, and closing the registration when it is no longer needed.  Submissions are made to the CSC through the UVMClick system using the Amendment, Incident, Continuing Review, and Closure Request activities.

Back To Top

Registrants revising a currently approved registration must complete an Amendment smart form in UVMClick, revise appropriate smart form fields, upload applicable documents, and submit to the CSC for approval. Changes involving addition of new controlled substances, addition of authorized users, and location of drug box must be approved by the CSC prior to implementing the changes.

Once approved, the Committee will return a signed approval memo back to the principal investigator.

NOTE: Amendments involving changes to drug box location, authorized users, and addition of new controlled substances require additional review by the IACUC or IRB prior to implementation.

Back To Top

Before a non-DEA Registrant (i.e. authorized user) is allowed to access to CS, to sign logs/inventories, or use controlled substances in the lab, they must first be added to the CSC registration as an authorized user via an amendment in the UVMClick system.

Authorized users are required to complete:

• the Questionnaire for Access to Controlled Substances for Research Purposes by Non-DEA Registration Holders and return it to the lab manager
• the UVM DEA Controlled Substances Training

Registrants should limit the number of authorized users to the minimum necessary. Authorized users who are undergraduates require additional supervision. A plan for supervision must be submitted to the CSC with the amendment.

Authorized users shall not be any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause.

The registrant is required to update their DEA registration with the new users at time of renewal, at time of a DEA onsite inspection or when new protocols are submitted, whichever comes first.

Back To Top

DEA Renewal

DEA research registrations are valid for one year. Renewals are completed through the DEA website. The DEA will conduct background checks as part of the renewal. DEA sends an electronic reminder to renew to the email address associated with the DEA registration. Registrants are responsible to ensure their registration remains current and active.

Renewal process guidance can be found here.

CSC Renewal

Researchers are required to renew their authorization with the CSC following DEA renewal. Annually, UVMClick will send a continuing review reminder to the registrant three months before the approval of a registration is due to expire. Additional reminders will be sent two months and one month prior to expiration.  The registrant or delegate must log into the system and complete a continuing review smart form and submit to the Committee for review.

Once approved, the Committee will return a signed approval memo to the principal investigator.

Back To Top

All employees and students are required to report theft, loss, or other diversions of controlled substances (CSs) immediately to the CSC upon discovery as follows:

1. Non-Registrants: Any suspected theft, loss or diversion must be immediately reported to the registrant unless the registrant is suspected to be responsible for the theft, loss or diversion of the CS. Registrants are then responsible to report as indicated in section b. below. If the registrant is suspected, then notify Police Services and the Office of Compliance Services as specified below:

• UVM Police Services at (802)656-3473 or police@uvm.edu,
• Anonymous reports can be made through UVM Office of Compliance Services https://www.uvm.edu/compliance/helpline

2. Registrants: Federal regulations require that registrants notify the Field Division Office of the Administration in their area, in writing, of the theft or significant loss of any CS, disposal receptacles, or listed chemicals within one business day of discovery of such loss or theft. To initiate a report, the registrant must complete and submit to the Field Division Office in their area, the DEA Form 106 regarding the loss or theft (21 C.F.R. §1301.76(b) and 21 U.S.C. §830(b)(1)(C)). The DEA Form 106 can be completed via the Theft/Loss Reporting Online Form or by downloading the fillable PDF version and submitting it to the Local Diversion Field Office.  https://deadiversion.usdoj.gov/21cfr_reports/theft/. These forms are only available to Registrants.

The Registrant must also contact UVM’s Office of General Counsel at General.Counsel@uvm.edu or (802) 656-8585 and the Research Protections Office at RPO@uvm.edu.

Spills

Breakage, spills, or other witnessed CS losses do not need to be reported as lost but need to be documented by the registrant and witness on the inventory record. CSs that can be recovered after a spill, but cannot be used because of contamination, must be disposed of in accordance with disposal procedures. UVM EHS department can be contacted to request assistance with spill cleanup if needed.

Back To Top

Registrants leaving the University must notify the DEA of the change in their registration and report any disposals of their controlled substances.

Registrants also have the responsibility to inform the CSC when they are leaving the University and wish to close a registration.

Criteria for Closure:

• Registrant no longer has CSs in their possession
• Registrant no longer has an active DEA registration

Notification must be done by completing a Closure Request activity in UVMClick. This provides an opportunity for the registration to describe the reason for closure and disposition of controlled substances. The closure request will be reviewed by the CSC and the registrant will be sent an official closure letter once the closure has been reviewed.

Back To Top

Researchers who use controlled substances as part of an approved research project must obtain a registration from the DEA and authorization from the UVM CSC. Access to the controlled substances must be limited to those individuals authorized in the DEA registration.

DEA registrants are responsible for complying with federal regulations, the CSC Policies and Procedures, and any additional reporting requirements specified either by the sponsor or the regulating body. For example, any project that includes animals must be in compliance with the University’s Institutional Animal Care and Use Committee.

In addition, the registrant’s primary responsibilities include, but are not limited to the following:

Designate and Document Authorized Users

Registrants must personally perform or designate to qualified authorized users, any activities involving use of controlled substances.  Even when specific tasks are designated, the registrant remains ultimately responsible for proper handling, storage, reporting, documentation of controlled substances as applicable by UVM policy and federal regulations.

Proxies are staff who are assigned by the registrant to create, edit, and submit registration materials on their behalf through the electronic protocol submission software.  Proxies have the same control as the PI. 

Proper Training and Oversight of Authorized Users

The registrant is responsible for ensuring that the authorized user has appropriate training prior to working with controlled substances by:  

• The UVM Controlled Substance Use training must be completed. UVM has a web-based training module that is available to registrants and authorized users via the CSC website. Topics such as the CSC registration approval process, investigator responsibilities, purchasing process, DEA schedules, secure storage, theft/loss/spills procedures, disposal considerations, and record keeping requirements are covered in the training. Any additional IACUC or IRB training as required to become key personnel on a protocol must be completed.
  • Trainings must be completed at least once every three years.
• DEA Registrants are further subject to requirements of other UVM lab safety programs.
• Investigate and report any significant problems pertaining to the use of controlled substances in writing to the CSC, DEA (as required), and/or other appropriate regulatory authorities.
• Correct work errors and conditions that may result in misuse or insecure substances.

Storage and Safeguarding Access

Registrants must store controlled substances at the location specified in the registration, in a double-locked, substantially constructed cabinet that is fixed in place as approved by the DEA. Each registrant is required to store CS in their own lock box. Registrants must institute a key access procedure and keep the key in a secure key safe or a locked drawer. Registrants must ensure that only authorized users have access to controlled substances and are not allowed to share a lock box for CS with other researchers.

Adherence to Approved Projects

It is the registrant’s responsibility to conduct research in accordance with the CSC registration and ensure adherence at all times by authorized users.  This includes making sure that amendments and other follow-on submissions are submitted for CSC review in a timely fashion, and then once approved, any changes are implemented by the authorized users.

Follow-on submissions include:

• Continuing Review reports
• Incident reports
• Amendments to update location, authorized users, CSs, upload current DEA registrations, etc.
• Final registration closure.

Retention of Records

As specified in 21 C.F.R. §1304.04, the registrant must keep at least two years of inventory records after the final disposition of the controlled substance. All records and logs must be readily available for periodic review by the DEA. Registrants must also maintain associated documents including approval letters, DEA & FDA approvals, certificates of registration, supplemental protocol applications, list of authorized users, purchasing, and destruction documentation. All DEA certificates of registration and all documentation related to the disposal or destruction of the CS must be maintained at each registered location in a readily retrievable manner and kept for official inspection.

Back To Top

Registrants are required to maintain a usage log of controlled substances at each physical location of controlled substances that can be reconciled to both purchasing and inventory records. Usage logs must be kept within a bound notebook and follow the templates provided on the CSC website.

Back To Top

The DEA requires that each registrant inventories the controlled substances under their possession as detailed at 21 CFR 1304.11. This requires a physical inventory of controlled substances to be completed on the date the registrant first engages in business with controlled substance(s) (initial inventory). In addition, an inventory must be taken on the effective date that the substance being used becomes controlled by DEA. A separate inventory must be performed at each registered location. The inventory must be updated as needed and at least biennially. Each registered researcher is responsible for his/her own periodic inventory.

The inventory will:

• consist of a hands-on counting of inventory and not a database check;
• be completed in a single business day, i.e., either before the opening or after the close of business; and
• be completed by at least two authorized personnel (registrant and authorized agent or authorized lab personnel).

Back To Top

UVM only allows the purchase of controlled substances through a purchase order. UVM prohibits the use of purchasing cards to purchase controlled substances (Purchase order requirements can be found on the CSC Forms and Guidance Page). The purchasing record (invoice, shipping document, or packing slip) must be annotated with the handwritten date of receipt and when logged into drug usage log. The amount purchased must match the amount received.

Back To Top

Transfers of CSs between registrants is not an approved method acquiring a CS at UVM. Transfers may only be done with explicit permission from the DEA and the CSC. Contact the DEA diversion officer to begin the process. If approval is granted by the DEA, an amendment to the CSC Registration must be submitted to request and document the transfer. CSC approval must be granted prior to the transfer taking place.

Transfers of controlled substances between two registrants are the same as the purchase of controlled substances from an approved vendor and therefore proper DEA procedures must be followed. Both parties must maintain proper documentation for any approved transfers.

Back To Top

21 CFR 1317

To minimize waste, DEA Registrants should only purchase quantities they intend to use by their expiration date. Damaged, expired, unwanted, unusable, or non-returnable controlled substances (CSs) must be accounted for, retained, and disposed of in accordance with applicable regulations. CSs that are to be disposed of remain subject to security regulations and supervision by the registrant. The DEA registrant is the person who “owns” and is responsible for the CS from receipt until use or destruction.

Registrants must dispose of CSs obtained for research by one of the following methods:

Disposal by Injection into an Animal Carcass

DEA Registrant can personally administer the CS into an animal carcass. The Registrant remains responsible to properly log the administration with a witness present. A signature on the usage log with a notation that the administration was for purposes of disposal is required by both the registrant and the witness.

Destruction

Disposal by UVM Approved Vendor. To utilize this method, contact UVM Risk Management & Safety at waste@uvm.edu to schedule pick-up and disposal by UVM’s approved vendor. The Registrant must maintain control of the CS until it has been properly transferred to the disposal vendor. Procedures for disposal are specific to each circumstance and may incur costs that are the responsibility of the individual researcher. This process may take several months, during which the registrant must maintain an active DEA registration and keep the CS in their inventory.

On-site destruction 21 CFR 1317.95(d) If a CS is destroyed at a registrant's registered location utilizing an on-site method of destruction, such as an RX Destroyer or similar product, the following procedures must be followed:

• The registrant plus two authorized users must be present to witness the destruction of the CS until it is rendered non-retrievable.
• Record the waste amount and signatures of the registrant and the witness on usage log and on DEA Form 41.

Note: Registrants are required to complete the “Registrant Record for Controlled Substances Destroyed”, DEA Form 41. Registrants are not required to submit the completed form 41 to the DEA, unless requested to do so. This form must be kept as a record of destruction and be available by the registrant for at least two years in accordance with 21 U.S.C. 827

Reverse distribution

While this is an option, this is not the preferred method of disposal as the process is cumbersome and expensive. If you wish to proceed with this process, please contact CSC staff for assistance.

A researcher may transfer CSs to a DEA registered reverse distributor who handles disposal of CS. A list of DEA registered reverse distributors can be found here. When a researcher transfers schedule I or II CS to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the researcher. When schedules III-V CS are transferred to a reverse distributor for destruction, the researcher must maintain a record of distribution that lists the drug name, dosage form, drug strength, quantity, and date transferred. A DEA-registered reverse distributor who destroys the CS is responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to DEA when the CSs have been destroyed. The Registrant packages up the CSs for transfer and should deposit the item(s) into/to a common carrier pick-up location on UVM campus (USPS, FedEx, UPS, etc.) themselves.  The common carrier delivers the CS to the Reverse Distributor where it’s tracked, stored and ultimately destroyed.  Then the Reverse Distributor provides a DEA-41 back to the Registration documenting its destruction. 

Back To Top

Registrants must be prepared at any time for internal and external, announced and unannounced inspections.

DEA

The DEA makes periodic unannounced inspections of registered controlled substance storage locations. Additionally, reporting of a loss or theft may result in a DEA inspection or visit. The DEA is a law enforcement agency, with the ability to assess civil and criminal penalties. Background checks may be conducted by the DEA as part of the inspection.

PIs must notify the Research Protections Office immediately if your lab is being subjected to an unannounced external investigation.

Controlled Substances Committee

CSC representatives will conduct inspections to monitor the status of DEA and CSC registrations, security of CSs, completion of training, and a review of required documentation. Inspections will occur not less than annually. These inspections may be at the time of continuing review. Registrants are required to address inspection deficiencies within an appropriate and specific time period (usually 14 days).

Institutional Animal Care and Use Committee (IACUC)

As part of the federally required IACUC semi-annual inspections, representatives will inspect storage areas, use/logs, and security controls. These inspections are in addition to the annual CSC inspections. Registrants are required to address inspection deficiencies within the specified timeframe.

Back To Top

The CSC will respond to observations of non-compliance and recommend corrective actions to appropriate personnel including Department Chair, Dean, Vice President for Research, UVM Police, and/or U.S. DEA. Consequences of non-compliance may include loss of authorization to use CS at UVM, revocation of the DEA registration, termination of employment, or referral to law enforcement agencies.

Back To Top