Helping Clients Navigate the Controlled Substances Act
“When dealing with controlled substances, the risk is not in doing or not doing something- the risk is in not knowing what to do. Uncertainty is the risk.” - Todd Prough, Founder and CEO
Services
At Controlled Substance (CS) Consulting, we help clients navigate the complexities of the federal Controlled Substances Act (CSA) and related state laws and regulations. The CSA is a set of laws designed to create a “closed system of distribution” to ensure that controlled pharmaceutical drugs are handled and used in an appropriate manner and are not diverted for misuse or abuse.
The CSA imposes numerous requirements on all entities of the pharmaceutical supply chain, including manufacturers, wholesale distributors, pharmacies, prescribers, and others. The CSA is complicated, nuanced, and continually evolving. Violations of the CSA can result in the initiation of criminal, civil, and/or regulatory actions, often resulting in the loss of handling privileges, jail time, and/or fines ranging from the tens of thousands to hundreds of millions of dollars.
Evaluating whether an entity has complied with the CSA can be a difficult and daunting task. It requires a thorough understanding of the CSA, investigative experience, a risk-assessment mindset, and oftentimes sophisticated data analysis. At CS Consulting Service, we have extensive experience in all of those areas and adopt that approach in the services we offer.
Pre-Litigation
Services prior to the initiation of any administrative, civil, and/or criminal litigation, including instances when litigation is not contemplated.
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Policy and procedure compliance review
Model policy and procedure guidance
Risk assessment of prescribing, dispensing, and ordering
Evaluation of pharmacists’ corresponding responsibility and distributors’ suspicious order monitoring systems
Internal and due-diligence investigations
Distributor and pharmacy restriction reviews
Fraud, waste, and abuse detection and prevention
Post-Litigation
Services after any administrative, civil, and/or criminal litigation has been initiated.
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Expert witness review, reports, and testimony
“Red flag” analysis of prescribing, dispensing, and ordering data
Forensic review of compliance policy and procedure and their implementation
Due diligence investigations for regulators, insurers, or upstream suppliers
Corrective action plans
Case preparation assistance
Monitoring services to ensure compliance
Financial Risk Analysis
Services for investors or prospective investors
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Risk analysis and assessment
Expert opinion on financial impact of emerging controlled substance issues
Internal and due diligence investigations of current and potential investments
Fraud, waste, and abuse detection and prevention
Education
Education services on CSA requirements and related topics
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Drug trends and harms
Pharmaceutical drug diversion
CSA requirements and implementation
Due diligence and corresponding responsibility
Drug theft, loss, and disposal
Physical security
Todd Prough, Ph.D.
CS Consulting’s founder and CEO, Todd Prough, Ph.D., brings over 30 years of investigative, compliance, managerial, and academic experience to his current role as a private consultant. During his 25-year career as a DEA Special Agent, he rose to lead the agency’s pharmaceutical investigations program, directing nationwide efforts to combat diversion through policy development, program implementation, and innovative data-analytics strategies. He also created and delivered training for healthcare professionals, regulators, and counsel. After retiring from DEA, he continued his work in diversion control by serving in the pharmaceutical compliance program of a Fortune 100 company. He is a trusted expert in CSA and DEA matters, including serving as an expert witness, and his combined experience in government, industry, and academia makes him uniquely qualified as a consultant in controlled-substances issues.
James Graumlich
James Graumlich brings more than 35 years of experience as a DEA Diversion Investigator, including extensive supervisory service, to his role as Senior Consultant at CS Consulting. He concluded his DEA career as a Staff Coordinator in the agency’s pharmaceutical investigations program, where he provided subject-matter expertise and oversight for administrative, civil, and criminal investigations of DEA registrants nationwide. His vast knowledge and experience in DEA matters including, registration, record keeping, security, and inspections make him an invaluable resource in CS Consulting’s mission to guide clients through the complexities of CSA and DEA matters.