Use of Controlled Substances in Research
- Responsible Office: Research and Innovation
- Current Approved Version: 10/30/2019
- Policy Type: Administrative
Policy Statement and Purpose
Certain research activities conducted under the auspices of VCU require the use of controlled substances. The use of controlled substances in research is governed by both state and federal regulations.
VCU expects that all individuals involved in the use of controlled substances for research will comply with all state and federal regulations regarding the procurement, record keeping, inventory, storage, use, and disposal of those substances.
The responsibilities associated with controlled substances are numerous, detailed, and regularly enforced by VCU, Virginia Board of Pharmacy (VBP), and the Drug Enforcement Administration (DEA). Delegation of the administrative responsibilities is permitted; however, the registrant is ultimately responsible for all activities occurring under their registration. For this reason, the Office of the Vice President for Research and Innovation (OVPRI) strongly discourages individuals from applying for registrations if those individuals are not comfortable with or do not have the capacity to assume the responsibility of ensuring that procedures are properly followed and that the required records are properly maintained. Individuals who are fined or who have violated the law will not be reimbursed by VCU for their legal defense.
VCU will not pay any fines or damages resulting from noncompliance with federal, state, and local regulations, or resulting from noncompliance with university policies; such fines or damages are the sole responsibility of the individual.
The vice president for research and innovation (VPRI) is the institutional official with ultimate responsibility for ensuring appropriate conduct of research at VCU. The VPRI is vested with the authority to suspend or deny any principal investigator’s (PI’s) controlled substances registration application or to suspend or revoke any PI’s controlled substances registration.
The senior associate vice president for research compliance is the DEA authorized official with responsibility for reviewing and approving DEA registration applications.
Employee Responsibility to Report Drug Diversion
An employee who has knowledge of drug diversion associated with the actions of a fellow employee, student, or supervisor has an obligation to report such information to firstname.lastname@example.org or to the VCU helpline at 1-888-242-6022 or www.vcuhelpline.com.
This policy does not apply to controlled substances dispensed by a practitioner to a patient in the course of professional practice as authorized by the practitioner’s license.
This policy does not cover teaching activity performed within a clinical environment.
Noncompliance with this policy may result in disciplinary action up to an including termination. VCU supports an environment free from retaliation. Retaliation against any employee who brings forth a good faith concern, asks a clarifying question, or participates in an investigation is prohibited.
Who Should Know This Policy
All individuals involved in the use of controlled substances for research are responsible for knowing this policy and familiarizing themselves with its contents and provisions.
An individual authorized by a registrant to use controlled substances under the registrant’s direction. Completion of appropriate training is required.
Any substance listed in the Controlled Substances Act (21 CFR, part 1300 to end) or Title 54.1, Section 3400 of the Code of Virginia. Lists of scheduling actions, controlled substances, and regulated chemicals are published by the DEA.
The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term "dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject. (21 USC §802(10))
Drug Enforcement Administration (DEA)
The agency within the United States Department of Justice that enforces the controlled substances laws and regulations.
Principal Investigator (PI)
The individual with overall responsibility for the conduct of research or other activity described in a proposal, protocol, or an award, and/or the individual with fiduciary responsibility for award management.
A full-time faculty member who holds a DEA or VBP registration and who is responsible for ordering, storing, using, recordkeeping, and disposing of controlled substances on their IACUC or VCU controlled substance research protocols. Completion of appropriate training is required.
Formal grant of specific authority for controlled substances activities by the DEA and by the Virginia Board of Pharmacy. Often referred to as a license or certificate.
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Research may be defined in additional detail in certain contexts.
Virginia Board of Pharmacy (VBP)
The regulatory board under the Department of Health Professions with “authority to license and regulate the dispensing of controlled substances by practitioners of the healing arts.” (§ 54.1-3304.1.)
The Office of the Vice President for Research and Innovation (OVPRI) officially interprets this policy. OVPRI is responsible for obtaining approval for any revisions as required by the policy Creating and Maintaining Policies and Procedures through the appropriate governance structures. Please direct policy questions to OVPRI. Questions regarding this policy also may be sent to the senior associate vice president for research compliance at email@example.com.
Policy Specifics and Procedures
PIs using controlled substances in research must obtain a VBP Controlled Substances Registration and a DEA Registration prior to ordering or using controlled substances. Only individuals named and designated as providing research oversight on an approved VCU Institutional Animal Care and Use Committee (IACUC) or VCU controlled substance research protocol may serve as a registrant for that protocol. Only full-time faculty members can be DEA registrants under this policy.
The Use of Controlled Substances in Research manual describes the procedures for complying with this policy.
Use of Controlled Substances in Research Manual
• Controlled Substance Definitions
• Template Forms
• Who Must Register
• Separate Registrations for Separate Locations
• Registrants Holding Clinical Practitioner Registrations
• Registration and Inspection
• After Receiving the Registrations
• Changes to Registrations
• Adding Controlled Substances to Already Approved Registrations
• Registration Renewals
• Authorized Users
• Personnel Screening Form – Authorized User
• Roles and Responsibilities
• Ordering Controlled Substances
• Record Keeping and Inventory Requirements
• Storage and Security
• Carrying Controlled Substances Between University Buildings
• Theft or Significant Loss
• Monitoring Inspections by VBP and DEA
• Institutional Monitoring
• Employee Responsibility to Report Diversion
• Close Out of Registration
Please refer to this document for complete information. See Related Documents section.
Environmental Health and Safety will be incorporating controlled substance monitoring into its lab inspection program
1. 21 CFR 1300 – 1399 (https://www.deadiversion.usdoj.gov/21cfr/cfr/)
2. Code of Virginia, Title 54.1, Section 3422 (https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3422/)
4. Disposal of controlled substances (scroll down to this section)
This policy supersedes the following archived policies:
|12/09/2013||Using Controlled Substances for Research|
|10/26/2016||Using Controlled Substances for Research|
|10/26/2016||Using Controlled Substances for Research (05/24/2017: updated hyperlink; uses updated policy template)|
1. What are the DEA schedules or DEA drug code numbers for the substances we are using?
DEA’s current list of controlled substances can be found here: https://www.deadiversion.usdoj.gov/schedules/index.html
2. Who do I contact if I have questions relating to this policy?
Questions relating to this policy or implementation of controlled substances activities at VCU should first be posed to firstname.lastname@example.org.
3. What is the contact information for our local DEA Diversion Field Office?
DEA diversion investigators assigned to VCU routinely change. Please contact email@example.com for current contact information.
4. What are the names and addresses of some controlled substance suppliers?
|NIDA Drug Supply||Covetrus North America||MilliporeSigma|
|6001 Executive Boulevard, Room #4119, MSC 9555||1499 Zeager Rd.||3050 Spruce St.|
|Bethesda, MD 20892-9555||Elizabethtown, PA 17022||St. Louis, MO 63103|
5. Is there a supplier of double lock storage cabinets for controlled substances?
All controlled substances must be stored in a “securely locked, substantially constructed cabinet” as per federal regulations.
Registrants can find standard narcotic cabinets by searching for “narcotic cabinets” on the internet. DEA regulations require that the cabinet be secured so that it cannot be removed. A locked drawer in a lab bench that is bolted to the floor or wall is generally sufficient.
If storing Schedule I or Schedule II controlled substances, the cabinet must be permanently constructed or attached to a building structure to prevent physical removal.
6. I am retiring or leaving VCU, or I will no longer be using controlled substances for my research. What do I do with my controlled substances? What do I do with my registrations?
Under no circumstances are controlled substances to be abandoned by a DEA registrant.
Registrants are expected to properly transfer or dispose of controlled substances inventory when controlled substances are no longer required or prior to departure from VCU. See our Disposal of controlled substances webpage for our disposal process.
Registrants wishing to terminate their active registration(s) must inform the DEA and the VBP of their intent to terminate. Contact firstname.lastname@example.org for the form that must be submitted to the DEA and the VBP when closing out a registration.
In addition, along with the form, the registrant must return their original VBP and DEA registrations, respectively.
If, in the future, the registrant intends to work with controlled substances again, the registrant will need to submit new applications to reinstate the registrant’s new state and DEA registrations, respectively.
7. When do I start counting the two-years required for retaining my records?
Records must be maintained for two years from the date of the last transaction on the record.