OIG:

• Compliance Program Guidance
• Measuring Program Effectiveness Resource Guide
• Board Resources
• Directors’ Duties

DOJ:

• DOJ Justice Manual (see §§44-47)
• Evaluation of Compliance Programs
• FCPA Guidance
• DOJ Memos and Remarks

US Sentencing Commission:

• US Sentencing Guidelines

• Corporate Integrity Agreement (CIAs)
• Deferred Prosecution Agreements (DPAs)
• Non-Prosecution Agreements (NPAs)
• DOJ Press Releases

• False Claims Act
• Anti-Kickback Statute
• Physician Self-Referral Law (Stark Law)
• OIG Advisory Ops
• OIG Fraud Alerts
• Safe Harbor Regulations
• PhRMA Code on Interactions with HCPs
• AdvaMed Code of Ethics

• Foreign Corrupt Practices Act (FCPA)

• Physician Payment Sunshine Act (in the Patient Protection & Affordable Care Act (ACA))
• State law links pending

• Prescription Drug Marketing Act (PDMA)

FDA:

• Food Drug and Cosmetics Act
• FDA Guidance Documents
• Warning and Untitled Letters

FTC:

• FTC Advertising Guides
• FTC Guidance Documents
• CAN-SPAM Compliance Guide
• Warning Letters
• Enforcement Cases

• Health Insurance Portability and Accountability Act (HIPAA)
• Health Information Technology for Economic and Clinical Health (HITECH)
• The Federal Trade Commission Act  (FTCA)
• DRAFT American Data Privacy and Protection Act (ADPPA) (as of August 2022)
• State law links pending

• Securities Exchange Act

• CFR 37: Patents, Trademarks, and Copyrights
• USC 35: Patent Law
• The Lanham Act (trademark law)
• The Copyright Act

• Medicaid Best Price Law
• Public Health Services Act (PHSA) 340B Drug Pricing Program
• Medicare Part D (Rebates) Regulations
• Part B Average Sales Price Regulations
• Veterans Health Care Act
• Medicaid Drug Rebate Program (MDRP) Guidance
• Medicare Part D Info for Manufacturers Guidance
• Medicare Part D Patient Assistance Program Information
• VA Office of Procurement

The Sherman Act (Antitrust Law)

• State Drug Distribution Registration
• Non-Retaliation Law
• Torts/Products Liability