Office of Research Integrity

The Office of Research Integrity exists to support the generation and dissemination of knowledge by facilitating safe and compliant research and scholarship.

 
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Controlled Substance Use in Non-therapeutic Research

Controlled substances are drugs that are regulated by the State of Ohio Board of Pharmacy (OBP) and Drug Enforcement Administration (DEA) due to abuse potential. These drugs are categorized into schedules based on whether they have a currently accepted medical use in treatment in the United States, relative abuse potential, and likelihood of causing dependence when abused.

 

UC's Office of Research Integrity (UCORI) oversees institutional compliance with UC's Individual Investigator Use of Controlled Substances in Non-Therapeutic Research policy and procedures. These apply to all individuals obtaining or working with controlled substances in animal research, culture systems, or in vitro laboratory research; it does not apply to human subject (clinical) research through UC Health.

 

2023 OBP classified Xylazine as Schedule III →

 

OBP & DEA Registration (click topic to learn more)

Obtaining OBP & DEA Registration →

 

This process may take several months. You should plan accordingly and may not order without licensure or borrow controlled substances.


  1. Investigators (registrants) notify their college (e.g. Associate Dean for Research) and department (e.g. Chair) of their intent to apply for OBP/DEA licensure.
  2. Investigators and authorized agents complete a Controlled Substances Security Release Form and UC training.
  3. Begin outfitting your lab with necessary equipment and develop lab-specific processes to ensure safe controlled substance ordering, storage, and use.
  4. Registrant completes a New License Application on the OBP eLicense website. Do not apply for a DEA registration until you have been granted an OBP TDDD license.
  5. Registrant reviews the DEA Researcher's Manual for an overview of the application process and a list of required application documents.
  6. Apply for a Researcher registration using DEA Form 225. The application will ask for information found on your OBP TDDD license.
  7. Use the DEA Site Investigation Guide to gather commonly requested information and materials prior to your on-site DEA visit.

 

View the full registration guide →

 

Registration Changes & Renewal →

 

Registrants are responsible for ensuring their OBP license and DEA registration remain valid. It is strongly recommended to submit your OBP and DEA renewal applications no less than 30 days prior to the expiration date to ensure agencies have adequate review/processing time.

To change part of your registration (e.g. registered address):

  1. Registrant submits changes on the OBP eLicense website.
  2. Once approved, the registrant submits changes on the DEA websiteChanges are effective upon DEA approval.
  3. Registrant communicates all registration changes (e.g. address, schedule, drug codes, registrant) to their college, department, and UCORI.

 

Registration Transfer →

 

  1. Submit notification to the DEA Special Agent in Charge at least 14 calendar days in advance of the proposed date of transfer in person or by registered/certified mail (with return receipt) with all information outlined in 21 CFR 1301.52(d). You may not transfer without DEA approval.
  2. Return all unused DEA Form 222s reflecting discontinued information to the DEA Registration Unit.
  3. If you have an inventory of controlled substances, follow final inventory and transfer procedures outlined in 21 CFR 1301.52(e). Transfers of Schedule I or II substances require a DEA Form 222.  You are only required to send a copy of the final inventory to the DEA if requested by the DEA Special Agent in Charge.
  4. If you have unused DEA Form 222s reflecting a discontinued name or address, contact the DEA Regional Office for disposal/return guidance.
  5. Notify your college and department of any changes (including transfers) to the registration.

 

Registration Termination →

 

  1. Perform a final inventory of controlled substances prior to destruction, then destroy all controlled substances and document their destruction on DEA Form 41.
  2. Notify your college and department of any changes (including termination) to the registration.
  3. Submit a Written Notice of Discontinuing Business form to the OBP at least 30 days in advance.
  4. Registrant emails the DEA Regional Office with the following:
    • a brief statement indicating they would like to take their registration out of business
    • a copy of their DEA registration marked “VOID”
    • a copy of the final inventory of controlled substances prior to destruction
    • copies of the completed DEA Form 41s documenting the subsequent destruction of all controlled substances in their inventory
    • the number of unused DEA Form 222s remaining (if any) so the DEA can recommend the best method to destroy or return these forms prior to registration termination. 
  5. Refer to UC procedures for additional instructions in the event of a registrant's unexpected departure (e.g. death, suspension).

 

Training

All individuals seeking to become a registrant or authorized agent are required to complete appropriate training on using controlled substances in research. UCORI provides an online Controlled Substance Procurement & Use training covering required topics like regulatory overview, controlled substance schedules, forms and recordkeeping requirements, storage, disposal, personnel changes, and best practices. This training can supplement other training that may be required by your department or college.

 

Recordkeeping

Registrants and authorized agents are required to retain controlled substance records for 5 years to comply with state and UC records retention.

 

UC Form Name Purpose
Controlled Substances Administration Log Administering a controlled substance from dilutions
Controlled Substances Authorized Agent List Registrant-authorized list of individuals permitted to obtain or work with controlled substances
Controlled Substances Dilution Solution Log Creating controlled substance dilutions from stock containers/vials
Controlled Substance Individual Drug Log Receipt of individual containers/vials of controlled substances
Controlled Substances Inventory Form Perform initial, annual (OBP), and biennial (DEA) controlled substance inventory
Controlled Substances Record of DEA Form 222 Use Track orders for controlled substances that require a Form 222 (Schedule I and II drugs)
Controlled Substances Security Release Form Every individual completes this form before obtaining or working with controlled substances
Controlled Substances Usage Log Administering a controlled substance from stock containers/vials

 

Contact

Mailing Address

Office of Research Integrity (ML 0663)
University of Cincinnati
P.O. Box 2100567
Cincinnati, OH 45221-0663

Street Address

51 Goodman Drive
Cincinnati, OH 45221-0663

View on map

General Inquiries

Phone: 513-558-5034

Fax: 513-558-4111

E-mail: integrity@ucmail.uc.edu