All entities that handle pharmaceutical controlled substances, such as prescribers, pharmacies, hospitals, clinics, narcotic treatment programs, distributors, manufacturers, importers/exporters, and disposal companies, are subject to mandatory registration and regulatory compliance responsibilities. For some registrants, compliance can be reasonably straightforward. But, for others, it can be overwhelming and confusing, involving multiple inspections and investigations that can lead to fines and other penalties.
Our Compliance Expertise
Many simple compliance mistakes or misunderstandings can lead to unwanted consequences, including diversion, civil or criminal action, fines, and other penalties. At 801 Consulting, we comprehensively review client systems and processes, analyze and identify problem areas, and recommend opportunities to implement proactive and/or corrective measures. We are the subject matter experts in the operational processes and controls necessary to comply with applicable laws and regulations.
Our depth of technical expertise uniquely positions us to proactively help clients develop the processes and procedures necessary to comply with state and federal laws regarding handling pharmaceutical controlled substances. We guide clients in developing and reviewing the necessary policies, procedures, and business practices based on our detailed understanding of the applicable regulations and help our clients improve their ability to promote regulatory compliance by leveraging data and analytics.
Our team includes the former head of the DEA Diversion Control Program, a former DEA attorney and senior policy advisor, and a former DEA Diversion Program Manager. As a result of our disparate perspectives in law, policymaking, and investigations, we can develop comprehensive strategies that address any pharmaceutical controlled substance compliance matter.
801 Consulting | Regulatory Compliance
If you need a compliance review, professional monitoring services, or professional consulting services, we urge you to speak with the experts at 801 Consulting. We provide responsible, focused solutions that can address any controlled substance compliance issue. Contact us by filling out our online form today.