Inspection Readiness
Introduction
Getting ready for an Audit/Inspection
An audit or inspection visit can occur at any time from the State of Illinois, Drug Enforcement Administration (DEA), or internally at University of Illinois Chicago (UIC).
All members of a research lab must be familiar with the federal and state guidelines as well as UIC policies for using controlled substances in animal research. You should be able to answer questions the auditor asks or know what resources to reference in order to find the answer. If you are not sure of the answer or what resources to reference, please refer the auditor to a person that does.
Things you should have ready to provide to an auditor if asked:
- Controlled Substance Licenses and Registrations
- Certificate of Registration (DEA Form 223) for each registered activity and physical location.
- IDFPR 097 Other Controlled Substance License for each registered activity and physical location.
- Controlled Substance Security Release Form for each member of the lab working with controlled substances (Only PI should have access to these)
- Requisition and Voucher forms from pharmacy purchases for the last 2 years, or purchase invoices for non-UIC pharmacy purchases
- Inventory records, including initial and annual/biennial inventory
- Dispensation or usage logs
- Keys to the lockbox where the controlled substances are held (Registrant and Authorized agents only)
- Controlled Substance Authorized Agent List, if applicable
- Controlled Substance Authorized User List, if applicable
- DEA 222 order forms, if applicable (Schedule II Controlled Substances only), for the last two years
- Power of attorney forms, if applicable (Schedule I and II Controlled Substances only)
- DEA Form 106 'Theft/Loss of Controlled Substances’ form and all related correspondence to DEA and IDFPR, if applicable
- DEA Form 41 Onsite Destruction forms, if applicable
Only answer questions that are asked by the auditor. If you do not know the answer, or know someone who does, please state that.
Obtain a receipt for any original documents taken off-site by a DEA investigator (DEA Form 12) and make copies of those documents.
Non-compliance
Non-compliance with state and DEA regulations can result in personal civil and criminal liability under state and federal law. Failure may also result in university disciplinary action under applicable university policies and/or rules, including loss or limitation of privileges to conduct animal or laboratory research at the university, or termination of employment.