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.
What do OSU personnel need to do?
Registration/Authorization – Investigators who seek to obtain a research or instructing registration for use of controlled substances in animal or laboratory research must first notify their college and/or department (e.g., Associate Dean for Research, College Research Officer) prior to registering with the Board of Pharmacy and/or the DEA. Anyone interested in becoming an authorized agent or acquiring controlled substances once approved as an authorized agent should contact the registration holder or responsible program administrator for their college/department/unit. See Registration Holders & Authorized Agent Programs for more details.
Training – All registrants and authorized agents must undergo appropriate training on the use of controlled substances in research in order to meet the regulatory requirements. The college and/or department of the registrant under whom the research is being conducted provides this training. A required, but not exhaustive, list of training elements includes: regulatory overview, controlled substance schedules, recordkeeping requirements and form use, storage, disposal, personnel changes, and best practices.
Storage – Registrants and authorized agents may only receive and store the minimum amount of controlled substances needed for current research. All controlled substances must be stored in a locked steel cabinet or a locked substantially constructed cabinet. Controlled substances should not be located near a glass panel where they can be visible from the outside.
Disposal – Damaged, expired, unwanted, unusable, or non-returnable controlled substances must be accounted for, stored, and disposed of in accordance with applicable state and federal regulations. Disposal of a controlled substance must render it non-retrievable. Though the DEA does not specify destruction methods, it does state, “the process utilized to render a substance ‘non-retrievable’ shall permanently alter the substance’s physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. A substance is considered ‘non-retrievable’ when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.”
If additional information is needed, please consult the Policy, visit our Controlled Substances FAQs page, contact the program administrator for your college (see table below), or contact our office at email@example.com or 292-5714.
Registration Holders and Authorized Agent Programs
Anyone interested in becoming an authorized agent or acquiring controlled substances once approved as an authorized agent should contact the registration holder or responsible program administrator for their college/department/unit or their college research officer.
Controlled Substance Forms
- OSU Controlled Substances Form 1.1 – CS Usage Record
- OSU Controlled Substances Form 1.2 A – CS Record Dilution Solution and Form 1.2 B – CS Record Administration Log – Note that Form 1.2A Controlled Substance Dilution and Form 1.2B Administration Logs to be used together
- OSU Controlled Substance Form 2 – Individual Drug Log
- OSU Controlled Substance Form 3 – Authorized Agent List
- OSU Controlled Substance Form 4 – Security Release
- OSU Controlled Substance Form 5 – Purchasing & Receiving Log
- OSU Controlled Substance Form 6 – Record of DEA Form 222 Use (Optional)