DEA CONSULTING AND MOCK AUDITS
The U.S. Department of Justice Drug Enforcement Administration (DEA) makes periodic unannounced inspections to audit registered controlled substance storage locations and laboratories.
In a typical audit, DEA Diversion Investigators ensure that the controlled substance licensee/registrant is compliant with the Controlled Substance Act or, if applicable, bring them back into compliance by:
- verifying: • Security practices: authorized personnel, controlled substance storage
- Record-keeping practices: DEA 222 forms (if applicable), invoices, complete and accurate inventories, use, and waste logs. Particular attention will be paid to documented discrepancies.
The DEA is a law enforcement agency, with the ability to assess civil and criminal penalties. Non-compliance violations can result in increasing levels of penalty, including:
• Letter of Admonition
- $10,000 fine to the licensee/registrant for each violation
- Suspension or revocation of a controlled substance practitioner and/or research registration
- Prison sentence
Sioux Services LLC has expanded services that include a DEA Compliance Consultant. Listed below are the services that we can provide:
- Sioux Services LLC can now provide “DEA Mock Inspections” as authentic as one done by DEA to evaluate that DEA registrants are in full compliance with DEA record-keeping requirements, that security requirements meet DEA requirements for the storing of controlled substances and that the registrant is in compliance with DEA Due Diligence policies to prevent diversion to the illicit market.
- Assist corporate legal counsel on DEA civil and administrative actions pertaining to the allegation on failure to maintain complete and accurate records, lack of security for controlled substances or the lack of due diligence when handling control substances.
- Developed in-service training programs tailored to meet the needs of DEA registrants including manufacturers, distributors, importers/exporters, hospitals/clinics, analytical labs, researchers, pharmacies and practitioners to include physicians and veterinarians.
DEA CONFORMATION SYSTEM (WCS)
Better yet we can provide your medical institution or office with Waste Confirmation System (WCS) this is a cloud-based system with mobile technology for documenting the process of wasting controlled substances.
WCS Administrators, assigned by department, enabling them to select employees approved for the wasting of controlled substances.
The ability to identify the complete wasting process by,
Product by description, make and form,
Method of wasting,
Date and time.
WCS also identifies Wasting Sessions where wasting activities are identified by not only product but by employees that are commonly referred to as Wasting Buddies.