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 due to COVID-19.
Once a license is obtained, you will need to complete a Controlled Substances Registration form (listed below) and email it to Trina Smith, Animal Care & Use Program Officer (ACUP Officer) in the Office of Research Compliance & Security, at firstname.lastname@example.org. Your completed registration will be kept of file in our office.
To dispose of Controlled Substances, each researcher will complete a Controlled Substances Disposal Form (listed below) and submit to ACUP Officer, 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.
- 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).
Standard Operating Procedures
- Controlled Substances used in Research (MSU OP 79.06)
- Disposal of Controlled Substances (pdf)
- Audit of Controlled Substances (pdf)
- Controlled Substances Registration Form (pdf)
- Controlled Substances Use Log (pdf)
- Controlled Substances Disposal Form (pdf)
- DEA Form 41 (pdf)
- Controlled Substances Audit Form (pdf)