Controlled Substances and Dangerous Drugs
Controlled substances are drugs that are regulated by the Drug Enforcement Administration (DEA) and the Ohio Board of Pharmacy because of potential for abuse. DEA regulations and Board of Pharmacy rules allow investigators to obtain and use controlled substances in research.
UToledo researchers who obtain, store and utilize controlled substances in their research MUST comply with all relevant State and Federal regulations, including all of UToledo's policies and procedures related to work with these substances.
Dangerous Drugs are defined by the Ohio Board of Pharmacy as any drug or drug product that bears a label containing the symbol “Rx only”, "Caution: Federal law prohibits dispensing without prescription" or "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" or any similar restrictive statement.
All persons’ using dangerous drugs (i.e., prescription drugs) in research MUST comply with all relevant State regulations related to work with these substances. Furthermore, all investigators must use pharmaceutical grade drugs (prescription drugs or dangerous drugs and controlled substances) in animal research, unless an exception is specifically approved by IACUC.
As new regulations have recently been imposed, faculty members are strongly encouraged to consult with Mahesh Pillai PRIOR to obtaining, storing, and/or utilizing controlled substances or dangerous drugs in their research.
Use of Controlled Substances and Dangerous Drugs in Research Training Video
UToledo Policy
The Use of Controlled Substances in Animal Research
Policy Number: 3364-70-27
Effective Date: May 27, 2022
Staff
Contacts for more information regarding controlled substances or dangerous drugs in research at UToledo.
Mahesh Pillai, M.D., Ph.D., C.I.P.
Director, Research Compliance
Office of Research & Sponsored Programs
Main Campus | R1 1020A | Mail Stop: 218
Office: 419.383.4251
Email: Mahesh.Pillai@UToledo.edu
Ravindika Dissanayake, Ph.D
Associate Compliance Analyst, IACUC
Office of Research & Sponsored Programs
Main Campus | R1 1020E | Mail Stop: 218
Phone: 419.383.5321
Procedures and Forms
The following contain important information and procedures for the use of controlled substances and dangerous drugs in research. The necessary forms are also provided with each procedure.
- IACUC Regulations for Use of Controlled Substances and Dangerous Drugs
- Options for Obtaining Controlled Substances or Dangerous Drugs at UToledo
- Schedules of Controlled Substances
- Registration and Licensing Requirements
- Registration Maintenance
- Purchasing
- Storage and Security Requirements
- Record Keeping and Retention Requirements
- Administration and Use Records
- Disposal and Destruction
- Transfer of Drugs
- Inventory Requirements
- Spills or Losses and How to Address Them
- Authorized Agent List
- Transfer Log for Dangerous Drugs