Using Controlled Substances in Research
Controlled substances used in research are regulated by the U.S. Drug Enforcement Agency (DEA).
Research Outreach & Compliance (ROC) Division complies with DEA recommendations and requirements by publishing the following directions, with in-house forms, providing links to DEA direction and their forms.
ROC has oversight of projects and people registered under Title 21 CFR 1300 – 1321.
What does DEA require to Register for use of Controlled Substances?
- Read the Controlled Substances Act – 21 CFR 1300 to end
- DEA rules and requirements are clearly expressed in this regulation
- Most vital Parts:
- CompleteDEA Form 225– Analytical Lab, Researcher w/Sched I, Researcher w/Sched II - V, Canine Handler, Exporter, Importer, Reverse Distributor, Manufacturer, Manufacturer BULK
- Register with Idaho State Board of Pharmacy.
What does ISU require, once you are Registered?
- Provide Research Outreach & Compliance with copies (pdf file via email to firstname.lastname@example.org) within 10 business days of license receipt:
- DEA License
- Idaho State Board of Pharmacy license
- Protocol submitted to DEA with application
- Follow ISU Purchasing rules when buying controlled substances for research
- Contact Wendy Holder, Buyer, with questions, (208) 282-3111
- Dispose of controlled substances and their by-products through ISU Environmental Health Safety & Sustainability Office
- Contact EHSS with disposal questions, (208) 282-2310
- Use ISU-specific forms for controlled substance management
- Participate in ROC bi-annual inspection (records & security)
- Follow other applicable ISU rules related to research and protocols;
find details at the ROC webpages for each subject area:
Which Policy Applies?
Controlled Substance Procedure and Policy questions
Controlled Substance Disposal
Environmental Program Manager
Please use the Hazardous Waste Disposal Request form