DEA Compliance Consulting Services

DEA Audits – Inspection Readiness Assessments ⦿ Immediate Services for Dealing with a Sensitive Issue (example – internal employee theft of controlled substances) ⦿ Complete Due Diligence for Full Compliance with Applicable Laws and Regulations Governing the Handling of Controlled Substances ⦿ Focused Advice and Support – Removing the Stress from Institutional and Individual Practice, and Industry Operations ⦿ Interpretation of Regulations ⦿ Complete Practitioner Controlled Substances Compliance Manual ⦿ Identification of “Red Flag” indicators of potential drug diversion ⦿ Conducting liaison with the Drug Enforcement Administration to “speed up the process” ⦿ Controlled Substances Export Reform Act (CSERA) and Implementing Regulations ⦿ Due Diligence for Controlled Substances Import and Export Act (CSIEA) ⦿ Drug Supply Chain Security Act (DSCSA) ⦿ Hospital Controlled Substances Assessment ⦿ Accountability and Recordkeeping ⦿ Assistance for all departments associated with the use of controlled substances to achieve full compliance with Drug Enforcement Administration laws and regulations as well as CMS and Joint Commission standards ⦿ Monitoring and Educating Staff; Software and Technology; Auditing; Reporting; Documentation ⦿ Controlled Substances Monitoring – Drug Usage Report (DUR) Analysis and Evaluation

How to Handle DEA Cyclic Inspections ⦿ Non-Practitioner registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) ⦿ How to Handle a DEA “Inspection”/Investigation ⦿ Practitioner registrants (physicians, dentists, veterinarians, mid-level practitioners, Hospitals, Clinics and Pharmacies) ⦿ Disposal of Controlled Substances ⦿ Drug Disposal Options for practitioners and pharmacies ⦿ Manufacturing accountability controls ⦿ Manufacturing Risk Areas ⦿ Distribution – Suspicious Order Monitoring ⦿ Verified, Accredited, Wholesale Distributor (VAWD) Goals ⦿ Complete Practitioner Controlled Substances Compliance Training ⦿ DMD – DDS and Administrative Staff DEA Compliance Webinar ⦿ Administration/Dispensing and Recordkeeping Requirements of Controlled Substance Medications

Quality Assurance/Continuous Quality Improvement Program ⦿ Provide SOP Manual, Model Compliance Indicators, Data Collection Forms and Establish Aggregation Process ⦿ Reviewing, Perfecting and Developing Policies and Procedures

Inventory Accountability ⦿ Business Strategy Sessions ⦿ Design and Implement Programs that Comply with all Applicable Laws and Regulations