Controlled Substance Use in Research
STEP 1- Georgia Southern Institutional Approval and Resource Confirmation
Researchers who wish to use controlled substances in their research must identify specific appropriately controlled space and obtain approval from their Department Chair and Dean to apply for license to store and use controlled substances in research on campus. All DEA license holders must register their license at the Office of Research upon receipt and renewal. Permission is required for all DEA schedules (I – V ). Researchers must then obtain and maintain an individual license and appropriate secured storage as specified by state and federal regulation. License requirements are based upon the schedule of the substance required for the research purpose.
Controlled Substance Schedules
Controlled substance licenses are maintained by Individual Researchers – not Georgia Southern. Each license holder is responsible for maintaining both state and federal licenses as well as following the related rules. Consequences of controlled substance storage and use violations are individual.
Obtaining a license in Georgia is a 2 step process.
STEP 2- Georgia Board of Pharmacy – Research Permit
The Researcher license is embedded in the Georgia Board of Pharmacy application form titled “Pharmacy Facility Application”.
The researcher must obtain a Georgia Board of Pharmacy Researcher Permit before beginning the process for the federal license. The application is available at the Board of Pharmacy website. The form for researcher applications is the “Pharmacy Facility Application.” On the form, under “License Type” choose “Researcher Pharmacy” and complete the appropriate sections of the form. According to the form, you should allow a minimum of 25 business days for processing of the application.
- The Georgia permit expires every 2 years, on June 30 of even years. (Expiration may not align with the federal license expiration.)
- the initial application fee is $100 (8/2019) and the renewal fee is $100 (8/2019). The Georgia Drugs and Narcotics Agency (GDNA) will inspect the facility before the permit is granted to assure you have appropriate security, procedures and documentation in place. (The DEA may rely on the GDNA inspection, or may come to inspect during the federal application process at its discretion)
- For additional information, the Board of Pharmacy is 404-651-8000.
STEP 3- Federal
Once the Georgia Board of Pharmacy issues a permit, a researcher must obtain a federal DEA license. Form 225 is the appropriate federal application form for research use of controlled substances. According to the DEA Diversion Office, the average processing time for a new DEA registration is 4-6 weeks.
The federal DEA license expires after 3 years.
The application fee is usually waived for a researcher at a state institution, however, in some circumstances, the fee may not be waived, so it is best to verify your specific situation with the DEA.
The Office of Diversion Control website includes links for online registration and renewal forms, as well as a pdf of Form 225. Note researchers registering for Schedule I approval cannot submit their initial application online.
Information and assistance for federal application can be found at:
- The Office of Diversion Control website
- From a DEA field office (see IX. Resources for contact information)
- By contacting the Registration Call Center at 1-800-882-9539.
STEP 4- Institutional Compliance Review Approval (as applicable)
- Submission of Georgia Research Permit and Federal DEA License for Registration.
- Email both permits along with the physical location of the secured drug box and documentation of department/college approval to firstname.lastname@example.org
- Human Subjects
- Institutional Animal Care and Use
- Biological Safety
- Industrial Hemp or Medical Cannabis
General Storage Rules
- General storage rule
- All controlled substances must be stored behind at least two differently keyed locks at all times.
- For keyed lockboxes
- Do not store the keys near the lockbox; and
- Do not store the keys together.
- For combination lock lockboxes
- Only the registrant and as few responsible individuals as possible should know the combination.
- Whenever anyone who knows the combination is terminated from employment, the combination(s) must be changed.
- Schedule I and II substances (e.g., Pentobarbital is a Schedule II drug)
- Must be stored in a safe or steel cabinet of substantial construction.
- If the safe or cabinet is less than 750 lbs., it must be mounted or secured to something of substantial construction (e.g., bolted to a wall or the floor, or the base imbedded in concrete).
- The safe/cabinet should have an inner and outer door with the locks for each door keyed differently.
- Standard “narcotics cabinets” can be purchased through a variety of resources.
- Schedule III, IV, and V controlled substances (e.g., Ketamine and Buprenorphine, are Schedule III controlled substances)
- Should be stored using one of the following methods:
- Preferred method: a wall mountable controlled substance lockbox with two doors and two locks (each lock is keyed differently).
- A single-lock lockbox that is stored in a drawer or cabinet that is secured at all times with a hasp and padlock. The drawer and cabinet should be substantially constructed such as in a drawer that is part of either a bench or cabinet that is mounted to the wall or floor.
- If a lab is not accessible to the public, then an option is to use a single-lock lockbox, stored in a drawer or cabinet in a room that is kept locked at all times.
- Schedule III, IV and V substances can also be stored with Schedule I and II substances.
- Recordkeeping Forms and Logs
- Controlled Substance Notebooks must be maintained and contain all relevant documents demonstrating the chain of custody and closed system of distribution. The sections below are strongly encouraged and each contains the relevant logs and forms needed. Documentation for Schedules III – V can be maintained together in one notebook. Schedule I and II must be maintained separately.
- Logs must include (minimum) Authorized User Signature form (specific to schedules in the registration); Initial and Biennial Inventory form; Acquisition/Purchase log; Usage and Disposal form; Reverse Distribution confirmations/instructions.
Last updated: 5/8/2023