Gates Healthcare Associates, Inc. support our clients to navigate their way through DEA rules, regulations and inspections. We works closely with key stakeholders to ensure harmonization of approach and plays a critical role in ensuring company compliance.
Our DEA regulatory consultants have conducted extensive research and organizational audits that developed solutions across decision making, business processes, sales monitoring, prescription monitoring and training for companies of all sizes in the pharmaceutical industry including drug wholesalers, hospitals and specialty pharmacies.
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
Training & Education
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
Policy & Procedures
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
Strategic Organizational Processes
Inventory Accountability ⦿ Business Strategy Sessions ⦿ Design and Implement Programs that Comply with all Applicable Laws and Regulations