Controlled Substances in Research

Controlled substances are drugs that are regulated by the Drug Enforcement Administration (DEA) and the Mississippi Board of Pharmacy because of potential for abuse. DEA regulations and Board of Pharmacy rules allow investigators to obtain and use controlled substances in research. Mississippi State University (MSU) researchers who obtain, store, and utilize controlled substances in their research MUST comply with all relevant State and Federal regulations, including all of MSU's policies and procedures related to working with these substances. 



Prescription or Legend Drugs are defined by the Mississippi Board of Pharmacy as drug which is required under federal law to be labeled with either of the following statements prior to being dispensed or delivered: (1) “Rx Only” or (2) "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian"; or a drug which is required by an applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by practitioners only. All persons using these drugs in research MUST comply with all relevant State regulations related to work with these substances. 



Furthermore, all investigators must use pharmaceutical grade drugs (prescription drugs or controlled substances) in animal research, unless an exception is specifically approved by the MSU Institutional Animal Care & Use Committee (IACUC).

Instructions for Researchers

All researchers who will use Controlled Substances in a non-clinical setting must have a DEA Certificate of Registration to do so.  Prior to registration with the DEA, you will need to first register with the Mississippi Board of Pharmacy. 

The process to obtain a DEA registration is easy to initiate and our office is happy to assist, but approval may take up to 6 months during normal activity and as long as one year with slower processing times.

Once a license is obtained, you will need to complete a Controlled Substances Registration form (listed below) and email it to Jess Marshall, jmarshall@orc.msstate.edu. Your completed registration will be kept on file in the Office of Research Compliance & Security (ORC&S).  

To dispose of Controlled Substances, a Controlled Substances Disposal Form (listed below) will need to be completed and submitted to ORC&S, who will provide further instructions on the disposal process.  For a full description of this process, you may refer to the Disposal of Controlled Substances SOP found below.  

Training 

As of February 2024, a new Controlled Substances in Research training is being offered to individuals who possess a DEA registration as well as their athorised users.

  • To Self Enroll in Controlled Substances in Research training in Canvas:
  1. Go to my.msstate.edu
  2. Scroll down the bottom of your myState home page 
  3. Under the "Classroom" section, the "Canvas Course Self Enrollment" box is located on the left hand side. This training is NOT under "Canvas Course Self Enrollment for Employees". 
  4. Click on "Select a course" and choose Controlled Substances in Research
  5. Mark the sliding tab that says "Self enroll, Yes/No" and mark "Yes" and then "Confirm"
  6. Go to canvas.msstate.edu to confirm the course is available to you on the Dashboard.  Note - you may need to scroll down past any announcements.

Resources

  • The MS Board of Pharmacy registration form can be found at: https://www.mbp.ms.gov/Pages/App-and-Fees.aspx   (For "Business Name" use Mississippi State University and your department. If this is your initial registration, leave "DEA#" blank and after DEA Registration is complete, you will update your Pharmacy Board registration. Note registration requires a $50 fee which must be submitted with your registration).
  • The DEA Registration application can be found at: https://apps.deadiversion.usdoj.gov/webforms2/spring/main?execution=e1s1  (For researchers at MSU, DEA Form 225 should be completed for Research (II-V). Researchers who are State employees are exempt from the registration fee).
  • For an alphabetical list of current DEA Schedule I,II,III,IV, and V drugs, please visit their site.

Standard Operating Procedures

Forms