4.0 Responsibilities

Each Principal Investigator (PI, defined as a “Researcher” on the DEA registration application) who is authorized to use controlled substances is responsible for understanding and complying with all applicable rules and regulations of the Federal Drug Enforcement Administration (DEA) and the State of Iowa - Iowa Board of Pharmacy Examiners (IBPE) regarding registration, purchase, use, and proper disposal of controlled substances used in his/her research work.  The PI is responsible and liable for any loss, theft, or misuse of any controlled substance acquired through his/her registration.

  • A Researcher must purchase controlled substances using his/her Federal DEA registration number through DEA/IBPE approved distributors.
  • The use of controlled substances is approved for individual researchers and only for the research location(s) described in his/her DEA application. Therefore, researchers must not distribute, transfer, or share the controlled substances to non-licensed researchers or other PIs. To do otherwise is considered a diversion of controlled substances and is against the IBPE/DEA rules and regulations.  Each PI who needs to use controlled substances in his/her research is required to register with the IBPE and DEA for a specific research location.
  • Researchers must maintain proper registration and documentation for the control of controlled substances by tracking the purchase, daily use, and disposal by maintaining specific records (see Appendices B1-B8).
  • Authorized laboratory personnel (also known as authorized daily users) must perform research activities under the supervision of the registered PI or his/her authorized agent. The authorized personnel must complete the daily use forms accurately and return the unused chemicals and partially used vials to the PI or his/her authorized agent at the end of the day for proper secured storage.
  • Used, expired, unwanted, or partially consumed controlled substances container(s) must be disposed of through EHS.
  • Controlled substance waste (used, expired, partially consumed, and generated from synthetic or analytical processes) is regulated by DEA. Researchers must treat the controlled substance waste separately and not treat them as a hazardous waste, biological waste or regulated medical waste. The researcher who wants to dispose of controlled substances that are mixed with hazardous chemical waste must consult with EHS to ensure compliance with RCRA regulations.
  • Researchers may contact EHS for answers to specific questions related to the registration, purchase, storage and security, and disposal of controlled substances.