Controlled substances used in research are regulated by the U.S. Drug Enforcement Agency (DEA). 

Research Integrity & Compliance (RIC) 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? 

1. Read the Controlled Substances Act – 21 CFR 1300 to end
   • DEA rules and requirements are clearly expressed in this regulation
   • Most vital Parts:
     • Definitions PART 1300
     • Registration PART 1301
       • Research Protocols scroll down to PART 1301.18
     • See also DEA's Pharmacist's Manual [Effective July 15, 2020, DEA withdrew the "Practitioner’s Manual" and it is not available]
2. CompleteDEA Form 225– Analytical Lab, Researcher w/Sched I, Researcher w/Sched II - V, Canine Handler, Exporter, Importer, Reverse Distributor, Manufacturer, Manufacturer BULK
3. Register with Idaho State Board of Pharmacy.

What does ISU require, once you are Registered?

1. Provide Research Outreach & Compliance with copies (pdf file via email to daveharris@isu.edu) within 10 business days of license receipt:
   
   • DEA License
   • Idaho State Board of Pharmacy license
   • Protocol submitted to DEA with application
2. Follow ISU Purchasing rules when buying controlled substances for research
   • Contact Wendy Holder, Buyer, with questions, (208) 282-3111
3. Dispose of controlled substances and their by-products through ISU Environmental Health Safety & Sustainability Office
   • Contact EHSS with disposal questions, (208) 282-2310
4. Use ISU-specific forms for controlled substance management
   
   • Controlled Drug Disposition/Administration Log
   • Drug Disposal Log
   • Drugs on Hand Log
   • Drug Check-out Log
5. Participate in ROC bi-annual inspection (records & security)
6. Follow other applicable ISU rules related to research and protocols;
   find details at the ROC webpages for each subject area:
   
   • IRB/IACUC/IBC Biosafety/Chemical Safety (through EH&S)

Which Policy Applies?

Use of Controlled Substances in Research ISUPP 7120

Contacts:

Controlled Substance Procedure and Policy questions

Controlled Substance Disposal