According to the U.S. Department of Justice, Drug Enforcement Administration, drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (C.F.R.) §§ 1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.
The purchase, use, storage, and disposal of controlled substances is regulated by the United States Drug Enforcement Administration (DEA) and the Louisiana Board of Pharmacy (LABP). Tulane University has established policies and procedures listed below to ensure compliance with such regulations on the use of controlled substances in research activities involving animal research and bench research. For human subject research where controlled substances are utilized, the Tulane University Human Research Protection Program Standard Operating Procedures regulate such use of controlled substances.
Policies & Procedures
Forms for Researchers
- Access Log for Controlled Substances
- Authorized User Attestation Form
- Authorized User Signature Log
- Biennial Inventory Form for Controlled Substances
- Continuous Usage Logs for Controlled Substances
- DEA Checklist of Required Records for Researchers
- Initial Inventory Form for Controlled Substances
- Letter of Verification Request Form for Controlled Substances
- OEHS Renewal Form for Controlled Substances
Other Important Documents
Controlled Substance License Applications
Researchers who would like to obtain a new CS license must contact the Office of Research Compliance for assistance.
Controlled Substance Licenses Fact Sheet
Controlled Substance Inspections
OEHS conducts annual inspections of research lab's controlled substances storage and documentation. These inspections prepare labs for inspections by state and federal regulators and prevent diversion of these drugs.
Controlled Substances Inspections Fact Sheet
Controlled Substances Inspection Prep Checklist
Inspection Form for Controlled Substances
Training
Training is required before working with Controlled Substances and annually thereafter. Users must be manually enrolled in the online course or sign up for a live training session by OEHS. Check the "Announcements" section of SciShield for times and zoom links of training sessions.
To request enrollment in the online module:
If you are the licensee, contact OEHS via email at OEHS@Tulane.edu with the following information: Licensee Name and License Number. OEHS will enroll you in a required training which can be completed on Bridge.
If you are not the licensee, the license owner must contact OEHS via email at OEHS@Tulane.edu with the following statement on your behalf: “I, (license owner), request for (name of requestor) to have access to the controlled substances course on Bridge (or Canvas for students). He/she is an approved user under my license(s), (license ### here)”. OEHS will enroll you in the required training.
Disposal of Controlled Substances
Controlled Substances Destruction Fact Sheet
The purchase, use, storage, and disposal of controlled substances is regulated by the United States Drug Enforcement Administration (DEA). Detailed information related to controlled substances can be found at http://www.deadiversion.usdoj.gov/.
The OEHS has received approval from the DEA to assist Tulane University researchers with on-site destruction of expired and unwanted controlled substances. We are available, by appointment, to assist at the Uptown, Downtown and Primate Center campuses.
Please note: Tulane researchers working with controlled substances are required to complete and submit the OEHS Renewal Form for Controlled Substances annually and and participate in the annual OEHS controlled substances inspections. Researchers who have not done this may not use the on-site destruction service. For more information, please contact the Help Desk at OEHS@tulane.edu.
To request assistance with destruction of expired and unwanted controlled substances:
- Complete DEA Form 41 - Sections A & B1. Use DEA Drug Codes to assist in the completion of Section B1.
- Save the form and e-mail it to OEHS@tulane.edu.
OEHS will coordinate all appointments for on-site destruction with the registrant or their designee and a TUPD officer. After destruction is complete, OEHS will retain the original signed destruction forms as a record of destructions performed. Scans of these forms will also be forwarded to the licensee for their records. The forms must be kept for at least 2 years.
