Why did EHS create the guidance document for handling controlled substances?
The DEA and the IBPE regulations are designed to assure that PIs (owners of registrations) have written policies and procedures to use controlled substances and prevent the inappropriate diversion or inadvertent access to controlled substances.
EHS has developed guidelines as a resource for research personnel. Laboratory Guideline for Managing Controlled Substances in Research Laboratories (CSG) clarifies the roles and responsibilities of the individual PIs (‘Researcher’ category DEA registration) with access to controlled substances in their research projects and describes proper disposal of partially used and expired substances, or orphan controlled substances, and the wastes containing controlled substances.
The EHS guidance document helps to ensure compliance with the Federal and State regulations; therefore, the guidance document is an important resource with regard to safety and security of controlled substances stored in research labs.
Which laws and regulations must be followed regarding controlled substances used for research purposes at the University of Iowa?
Controlled Substance Act of 1970 and the Code of Federal Regulations (21 CFR, part 1300 to end).
State of Iowa:
2009 Iowa Code Chapter 124 - Iowa Controlled Substances Act. See paragraphs 205.11 – 205.13 for additional provisions relating to administration and enforcement. Also see chapter 124A. For more information, refer to the State of Iowa Regulations and Iowa Administrative code (Pharmacy Board) 657 I.A.C. Chapter 10 - Controlled Substances.
Who should I contact for questions regarding the use of controlled substances for research purposes at UI?
The Office of the Vice President for Research (OVPR) has designated the EHS as a resource to assist in matters relating to controlled substances guidance. EHS staff will provide guidance for laboratories attempting to dispose of orphan DEA regulated materials. Please call EHS at 5-8501 (or Bill Murray at 335-4624) for assistance.