The federal Drug Enforcement Agency (DEA) as well as the Illinois Department of Professional Regulations may make unannounced inspections of any registrant’s controlled substance storage location. During an inspection, a diversion investigator will perform an audit to ensure compliance with security and record keeping requirements.
The DEA, part of the U.S. Department of Justice, is a law enforcement agency that can assess civil and criminal penalties. While compliance investigators may work with registrants to bring them into compliance, non-compliance can also result in:
- Letter of admonition
- Fines of $10,000 for each violation (including negligent record keeping)
- Suspension or revocation of licenses
- Prison sentence
Always be prepared for an inspection as they may occur at any time. The registrant, their agents, and all authorized personnel should be familiar with the federal and state security and recordkeeping requirements as well as the University’s policies and procedures. The state and federal regulations require that controlled substances records be “readily retrievable” so all laboratory members involved in the handling of controlled substances should know where the records are stored and be able to produce them for an inspection.
If a DEA Diversion Investigator arrives for an inspection,
- Verify their identity – They should present a government photo identification as well as provide a business card.
- Inquire as to the reason for the inspection (e.g., routine, for cause).
- Immediately notify the registrant and the Controlled Substance Compliance Coordinator that a Diversion Investigator has arrived and the reason for the inspection.
- The registrant signs the Notice of Inspection (DEA Form 82), which acts as informed consent.
- If requested, provide access to the controlled substance storage cabinet or safe.
- Be prepared to provide the following documents:
- Hard copies of DEA and State of Illinois controlled substance licenses.
- Authorized personnel log and screening statements.
- Laboratory policies and procedures regarding security, ordering, storage, and administration of controlled substances.
- Most recent inventory
- Current logs
- Disposal records
- Purchasing records (i.e., invoices, packing slips, 222 forms) with Schedule I & II records separate from III-V.
- Breakage/spillage reports (DEA Form 41).
- Theft/loss reports (DEA Form 106)
During the inspection:
- The DEA investigators will typically have records from suppliers of the controlled substances sold to the registrant. They may ask to see the documentation of the receipt of the drugs as well as any subsequent records of the use of the drugs. In addition, they will verify the current inventory against your records.
- Provide copies of any records requested by the DEA. Obtain a receipt (DEA Form 12) for any original records and/or controlled substances taken by the DEA.
- Take notes of all recommendations and observations made by the investigators.
- Ask questions so that corrective actions can be implemented (i.e., What does the DEA want you to do?).
- Answer questions concisely and do not volunteer information that is not requested. If you do not know the answer to a question, offer to find the answer or find someone that can answer their question. Ask for clarification if you do not understand a question.
- Be polite and do not argue or debate with an investigator.