Controlled Substances in Research
When using controlled substances in research, all Ohio State employees must comply with federal and state regulations, as well as institutional guidelines. This page offers a collection of important documents and links related to controlled substances compliance.
Registrants are appointed by the department head and their numbers are limited by the Drug Enforcement Administration (DEA). Authorized users are University employees authorized to use controlled substances by the department’s registrant.
Overview of Controlled Substances Program
Controlled substances are drugs that are regulated by the Drug Enforcement Administration (DEA) and the State of Ohio Board of Pharmacy because of potential for abuse. Federal and state guidelines govern the responsible conduct of research associated with the use of controlled substances. Failure to meet DEA and Board of Pharmacy registration and licensing requirements specific to the use of controlled substances in animal and laboratory research may result in regulatory sanctions, fines, and/or drug diversion of controlled substances from their lawful purpose into illicit drug traffic. DEA regulations and Board of Pharmacy rules allow faculty and staff researchers to obtain and use controlled substances in IACUC-approved animal research or Institutional Biosafety Committee (IBC)-approved research with cell culture systems or other in vitro analyses (“laboratory research”). To do so, investigators must either:
- hold a current individual DEA research or instructing registration and a State of Ohio Board of Pharmacy Terminal (TDDD) Distributor License or
- conduct their research as an authorized agent of a university official or investigator who holds a current DEA registration and Board of Pharmacy TDDD License.
Training Requirement:
When using controlled substances in research activities, all employees in the College of Food, Agricultural, and Environmental Sciences must comply with federal and state regulations, as well as institutional guidelines. This module provides FAES registrants and authorized agents training on the use of controlled substances to meet the regulatory requirements. Training includes a regulatory overview, controlled substance schedules, recordkeeping requirements and form use, storage, disposal, personnel changes, and best practices.
The training is available in OSU BuckeyeLearn, “CFAES Controlled Substances in Research.”
Links and Forms:
University Policy on Individual Investigator Use of Controlled Substances in Non-Therapeutic Research
CFAES Standard Operating Procedure on Controlled Substances
OSU Controlled Substance Forms may be downloaded at: orc.osu.edu/regulations-policies/controlled-substances/
OSU Controlled Substance Form 1.1, Controlled Substances Usage Log
OSU Controlled Substance Forms 1.2A, 1.2B: Controlled Substance Dilution and Administration Logs (to be used together)
OSU Controlled Substance Form 2, Individual Drug Log
OSU Controlled Substance Form 3, Controlled Substances Authorized Agent List
OSU Controlled Substance Form 4, Controlled Substance Program Security Release
OSU Controlled Substance Form 5, Purchasing/Receiving Log
OSU Controlled Substance Form 6, Record of DEA Form 222 Use (Optional)
DEA Order Forms Request (for DEA Form 222), deadiversion.usdoj.gov/online_forms_apps.html
Registrants Inventory of Drugs Surrendered (DEA Form 41), deadiversion.usdoj.gov/21cfr_reports/surrend/index.html
Report of Theft or Loss of Controlled Substances (DEA Form 106), deadiversion.usdoj.gov/21cfr_reports/theft/index.html
TTTD License Application form, pharmacy.ohio.gov/Documents/Licensing/TDDD/Apps/Limited%20License%20Application.pdf
U.S. Department of Justice Drug Enforcement Administration Office of Diversion Control
DEA Security Regulation (21 CFR §§1301.71 -1301.76)
Controlled Substance Schedules
Lists of Controlled Substances and Exempt Chemical Preparations
Other University Policies:
Research Data Policy
Resoures
Registrants
Authorized Agent/User
Purchasing
Storage & Security
Disposal
Loss & Theft