When Principal Investigators purchase, dispense or destroy controlled substances used in their research, DEA and State of Iowa rules and regulations must be followed and documentation of the controlled substance inventory maintained.
EHS has developed a detailed guidance document entitled Controlled Substance Guideline Manual.
Prior to the purchase and use of controlled substances in research, PIs must register with the Iowa Board of Pharmacy Examiners (IBPE) and the Drug Enforcement Administration (DEA).
- The IBPE registration can be completed by downloading the pdf file. The IBPE registration must be completed first and the registration approval received prior to initiating the DEA registration process.
- When completing a new IBPE registration application, respond to question no. 6 as "pending" unless you already have a Federal DEA# (for example you have coming to Iowa from another state); respond to question no. 7 as "N/A", unless you have an Iowa Professional License #, e.g. as a Pharmacist.
- Although the IBPE form does not state that you need to include a copy of the protocol describing how you intend to use the controlled substance, you will avoid further delays by sending the protocol with your application and check.
- After receiving approval from the IBPE, an application to the DEA may be initiated. Click on the following link to access the online application to register with the DEA. When completing the online application, please note the following:
- On the second screen, UI Researchers are fee exempt.
- On the third screen you will be asked to provide information regarding the 'certifying official'. The University of Iowa's certifying official is Susan Klatt, University Secretary. Her phone no. is 319-335-3552. Email: firstname.lastname@example.org
- You should keep a copy of the form that you submit electronically.
Controlled substances must be stored in a locked cabinet with a solid door in an area that can be locked when it is not occupied. Access to the room and secure safe/cabinet must be kept to a minimum number of authorized users.
Receipt of Controlled Substances
A receipt log (also known as the 'receiving log') for controlled substances must be maintained at each location where controlled substances are stored. A separate page should be maintained for each controlled substance.
Daily use of controlled substances for research or surrendered for disposal must be documented, using appropriate internal forms, invoices and DEA forms.
The DEA has authorized the University to dispose of controlled substances that have been used in research, but only by following a very specific procedure. Contact EHS at 335-8501 (or Bill Murray at 335-4624) to request this service.
The PI must keep all records of inventories and logs of controlled substances for a period of at least two years after disposal of a controlled substance.
Inventory and disposal records must be available for inspections and copying by IBPE or DEA.
Please contact EHS at 335-8501 for assistance with general questions about managing controlled substances in research labs.