DEA Registrants are responsible for monitoring the security, recordkeeping, inventory, handling, and disposal of controlled substances in their possession. EH&S assists in this process by providing annual controlled substance inspections for DEA Registrants to ensure University compliance with DEA regulations.
DEA Controlled Substance Audits
The Drug Enforcement Administration (DEA) may conduct controlled substance audits at any time. DEA Registrants and EH&S personnel may not receive prior notification of their visit. DEA Investigators provide these audits to ensure that DEA Registrants are in compliance with regulations set forth in the Controlled Substances Act. They may verify the following:
- Security and Storage Practices: Access control, controlled substance storage, and authorized personnel.
- Record keeping Practices: Accuracy of usage, physical inventory and disposal logs, shipping invoices and receipts, and applicable DEA forms (e.g., DEA Form 222).
As a federal law enforcement agency, the DEA has the capability to give civil and criminal penalties. Thus, noncompliance violations can result in increasing levels of penalty, which may include the following:
- Letter of Warning
- Fines for each DEA violation
- Suspension of DEA Registration
- Revocation of DEA Registration
DEA Registrants and their Authorized Users should be knowledgeable and prepared to provide the following to DEA Investigators upon request:
- USC laboratory policies and procedures regarding security, procurement, storage, handling, and disposal of controlled substances
- Copy of DEA Registration
- Controlled Substance Use Authorization Form (CS Form A)
- Access to controlled substance storage
- Usage and disposal logs (CS Form B); dilution usage and disposal logs (CS Form B-1), if applicable
- Initial and annual physical inventory records (CS Form C)
- Procurement records (e.g. invoices, packing slips, DEA forms)
- Theft or loss reporting form (CS Form F), and DEA Form 106, if applicable
- Breakage or spillage reporting form (CS Form F), and DEA Form 41, if applicable
EH&S Controlled Substance Inspections
The Office of Environmental Health & Safety may conduct announced or unannounced controlled substance inspections. Routine inspections are conducted to evaluate the effectiveness of the USC EH&S Controlled Substance Program and to verify adherence of participating members to federal, state and University regulations and policies.
DEA Registrants and Authorized Users will be notified in advance of annual controlled substance inspections. Unannounced controlled substance inspections may occur at any time and can be based upon random selection, changes in CSUA paperwork and/or prior inspection discrepancies and deficiencies. All inspections will be conducted by trained EH&S personnel.
The following items are subject to evaluation by EH&S during controlled substance inspections:
- Accuracy of current CSUA paperwork
- Particular attention will be paid to accuracy of current Authorized Users and subsequent EH&S CS training, IACUC protocols, and noted storage location of controlled substances.
- Proper storage and security measures
- Proper handling procedures
- Accuracy, completeness and maintenance of relevant records (e.g. usage/disposal logs and physical inventories)
- Proper disposal of empty, expired or unwanted CS
- Correction of prior inspection discrepancies and deficiencies
Inspection results are communicated to DEA Registrants and the CS Program Manager at firstname.lastname@example.org. NOTE: Inspection findings are subject to remediation within five (5) or twenty (20) business days depending on the severity of the findings. The CS Inspection Process Flow Chart depicts how findings that are not corrected may be progressively escalated to higher authority levels.