Prescription drug regulation is one of the most highly scrutinized and legally complex areas of healthcare law. This course provides an in-depth analysis of federal and state laws governing the prescription, distribution, and dispensing of controlled and non-controlled substances. Topics include DEA regulations, the Controlled Substances Act (CSA), FDA oversight, state licensing requirements, fraud and abuse laws, telemedicine prescribing rules, and liability issues for healthcare providers, pharmacists, and drug manufacturers. The course will also explore criminal penalties, compliance strategies, enforcement trends, and case law related to prescription drug laws.
Course Objectives
By the end of this course, students will:
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Understand Federal and State Prescription Drug Regulations – Examine the Controlled Substances Act (CSA), FDA oversight, and state-level prescribing rules.
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Analyze DEA Regulations and Compliance Requirements – Explore DEA registration, recordkeeping obligations, and controlled substance monitoring.
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Evaluate State Prescription Drug Laws – Study licensing requirements, Prescription Drug Monitoring Programs (PDMPs), and state-specific variations in prescribing laws.
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Examine Legal Issues in Controlled Substance Prescribing – Learn about Schedule II-V drugs, opioid regulations, and prescribing restrictions.
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Assess Liability Risks and Enforcement Actions – Understand criminal, civil, and administrative penalties for prescription drug violations.
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Explore Fraud and Abuse Prevention Laws – Analyze the Anti-Kickback Statute, Stark Law, and False Claims Act implications in prescription drug regulation.
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Understand Legal Issues in Telemedicine Prescribing – Examine telehealth laws, digital prescriptions, and evolving federal/state regulations.
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Develop Compliance Strategies to Avoid Legal Risk – Learn best practices for recordkeeping, audits, and avoiding prescription fraud allegations.
