Roswell Park Comprehensive Cancer Center Controlled Substances in Research Monitoring Program

Roswell Park Controlled Substances in Research Monitoring Program ensures compliance with federal and state regulations pertaining to controlled substances in research, administered to people as part of a research protocol and used for in vitro or analytical research. The program is comprised of the following:

• Research Diversion Prevention Committee. Ensures compliance and oversight of the use of controlled substances in research. The committee meets bi-monthly, is led by the Chief Scientific Officer and consists of personnel from major units in which controlled substances are used in research. For details about these regulations, see the links listed in References and Resources below. Additional questions can be escalated to Research Diversion Prevention Committee for review and approval, as needed.
• The Departments of Drug Diversion, Legal and Occupational and Environmental Safety (OES) provide guidance of regulatory conditions and technical assistance as needed by any research staff in utilizing controlled substances in their activities.

Researcher roles & responsibilities

The controlled substance licensee/registrant is responsible for applying effective internal controls to guard against theft and diversion of controlled substances; including screening personnel who may come in contact with substances and properly storing and securing the substances per schedule requirements.

To conduct research at Roswell Park involving controlled substances, you must:

1. Inform the Office of Research Subject Protection. When applicable, investigators or supervisors of research are responsible for obtaining approval for their use from the appropriate institutional committees that oversee human and animal subject research (e.g., the relevant Institutional Review Board or the Institutional Animal Care and Use Committee) and must report their intention to use controlled substances to external funding sponsors upon submission of grant applications.
2. Be covered by applicable State and Federal licensure processes relevant to the research, including DEA registration(s), NYSDOH licensure, and/or NYS Office of Cannabis Management (OCM) licensure:
   1. You have your active New York State research licenses (if applicable) and DEA registration for controlled substances in research. Submit a copy of the required NYS and DEA registrations to the Research Diversion Prevention Committee and the Office of Research Subject Protection upon receipt, and the names and emails of individuals who will have access to the controlled substances OR
   2. You are approved as an Authorized Agent or Authorized Laboratory Personnel under the license and registration of another Roswell Park researcher. Individuals functioning as Authorized Agents or Authorized Laboratory Personnel must conduct all controlled substance activities under the DEA registration of an identified Registrant. The applicable DEA Registrant must be clearly identified within the associated research protocol documentation.
3. Complete required training
   1. In addition, before any work with controlled substances begins in your lab, you must complete training on proper record-keeping, storage, disposal, and waste.

For more information about these processes, contact Research Diversion Prevention Committee.

As an active NYS licensee/DEA registrant, you must:

• Follow the outlined processes to purchase and receive controlled substances.
  Please note: this does not apply if samples of the products containing controlled substances are collected from study participants or from other sources (i.e. disposed products)
• Properly store and secure controlled substances per NYS and DEA regulations
• Properly dispose of Controlled Substances per NYS and DEA regulations
• Properly screen and document as authorized personnel or authorized agent the Roswell Park investigators and laboratory staff who will use the controlled substances for research under your license and registration.
• Maintain at all times accurate and complete records per compliance regulations for 5 years
• Maintain an up-to-date registration with the Research Diversion Prevention Committee
• Immediately report to any diversions, significant loss and/or unusual events or activities involving controlled substances under your supervision to
  • Public Safety: Non-Emergency, 716-845-3069; Emergency, 716-845-3333
  • Pharmacy Department: Kathy Galus, 716-845-8370
  • Office of Research Subject Protection: 716-845-8769
  • Research Diversion Prevention Committee. This committee will determine who will complete Form 106 and submit to the DEA.
• Meet annually with the Research Diversion Prevention Committee to review controlled substances records and identify any areas where improvement is needed.

References and resources

• Title 21, Part 1300-1308 of the Code of Federal Regulations (CFR) and Article 33 of the New York State Public Health Law. Applicable laws and regulations governing the use of controlled substances in research include the Controlled Substances Act (21 U.S.C. Chapter 13 § 801 et. seq.); DEA regulations 21 C.F.R. § 1300 et. Seq; Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances, Public Health Law, Sections 338, 3300, 3305, 3307, 3308, 3309, 3381, 3701(1), (6), art. 33.
• DEA Drug Schedules I - V (21 CFR, Part 1308) Listing controlled substances by schedule I - V (see parts 1308.11 - 1308.15)
• Policy 1110.1 Use of Controlled Substances in Research (must be on Roswell Park network to view)
• Policy 1419.1, Use of Controlled Substances (must be on Roswell Park network to view)
• Policy 1510.1, Safely Stored Medications (must be on Roswell Park network to view)

Questions?

For information on, or questions about, Roswell Park policy regarding use of controlled substance in research, procedures, assistance, and more contact the Research Diversion Prevention Committee:

Email