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Using Controlled Substances in Research

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
  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:

Which Policy Applies?

Use of Controlled Substances in Research ISUPP 7120

 

Contacts:
Controlled Substance Procedure and Policy questions
Dave Harris
Assistant VP Office for Research
(208) 282-2592
 
Controlled Substance Disposal
Jennifer Parrott
Environmental Program Manager
Please use the Hazardous Waste Disposal Request form  
(208) 282-3498 or 282-2310