Controlled Substance FAQs
I would like to conduct my research with controlled substances as an authorized agent of another registration holder: whom should I contact?
Investigators who seek to use controlled substances in animal or laboratory research must first notify their college and/or department (e.g., Associate Dean for Research, College Research Officer). If you are proposing to use a Schedule I controlled substance, you must get own registration by applying to the State of Ohio Board of Pharmacy and the DEA. Please refer to the policy for specific details. If you are proposing to use Schedule II-V controlled substances, it may be possible to perform your research as an authorized agent of the registration holder in your college/department.
Where do I purchase controlled substances for my research?
You may purchase controlled substances from internal university sources or from outside distributors like Sigma-Aldrich; Butler Schein, Inc.; Fort Dodge Laboratories; etc. Contact your purchasing department or your college/department registration holder or their program administrator for more information.
How can I dispose of expired, unwanted, damaged, or unusable controlled substances in my inventory?
You should contact the registrant or your college and/or department to help determine which of the following disposal methods is most appropriate for your lab and the substances in question. See the controlled substances policy, section VIII for more information on disposing controlled substances.
Disposal options include:
- On-site disposal – see below
- Reverse Distribution – For contact and cost information for reverse distributors contact the Office of Environmental Health and Safety
- Contact the supplier for a return
What methods can I use to dispose of controlled substances on-site?
The Registrant Record of Controlled Substances Destroyed form (DEA Form 41) must be completed prior to disposing of any controlled substance. A copy of the completed form must be retained by the registrant or the authorized agent for at least five (5) years.
Commercially available active-charcoal chemical digestion systems like Rx Destroyer TM or DRUGBUSTER® can be purchased for the use of on-site disposal to render a controlled substance non-retrievable. Alternatively, controlled substances can be rendered non-retrievable by mixing them into latex paint and allowing the paint to solidify. Once dry, the latex paint plug can be disposed of in the regular trash. If this method is employed, the paint mixture must be securely maintained (e.g., supervised and/or locked in the lab’s controlled substance storage cabinet) until completely dry.
Disposal methods that do not permanently alter the substance’s physical or chemical state or render the controlled substance non-retrievable (e.g., flushing, rinsing down the drain, or mixing the controlled substance with an undesirable substance like coffee grounds or kitty litter) are no longer sufficient in meeting the DEA’s “non-retrievable” standard.
I am performing a human (or veterinary) clinical trial: does the Individual Investigator Use of Controlled Substances in Non-therapeutic Research policy apply to me?
The policy does not apply to controlled substances used in Institutional Review Board (IRB)-approved research involving the use of human subjects by university faculty and staff who are licensed healthcare practitioners in the State of Ohio and hold current DEA registrations. Further, the policy does not apply to controlled substances used in Institutional Animal Care and Use Committee (IACUC)-approved veterinary clinical trials by university faculty and professional staff members who are licensed veterinarians in the State of Ohio and hold a DEA controlled substance registration for veterinary use.
How do I receive training on the use of controlled substances in research?
Your college or department provides this training required by this policy whenever possible. If you are serving as an authorized agent, contact the registration holder or responsible program administrator for your college/department/unit. When necessary, training can be provided by another college/department (with its permission).
How can I tell if a drug I want to use in my research is exempt from the controlled substances registration, documentation, storage, and security requirements?
Without a DEA registration, investigators may lawfully purchase, use in research, and store only those controlled substances in the forms described on the DEA exempt chemical preparation list. Use of exempt chemical preparations is intended for laboratory, industrial, or educational purposes and not for immediate or subsequent administration to a human being or other animal.
Does everyone in my lab need to be considered an authorized agent?
No, in fact the number of authorized agents should be limited to the smallest number of people possible. Only those faculty, staff, and students in the laboratory who have direct access to controlled substance storage locations, or those who will come in direct contact and perform experiments with the controlled substances, or those who would be authorized to pick-up controlled substances from university sources should become authorized agents.
Those whose role will require them to become an authorized agent will need to be listed as an authorized agent on OSU Controlled Substance Form 3 – Authorized Agent List, complete a Security Release using OSU Controlled Substance Form 4- Security Release , and undergo a background check.
Any laboratory staff who do not come into contact with or have direct access to the controlled substances themselves (e.g., they work on other experiments, they perform custodial duties in the laboratory, etc.) should not become authorized agents.