Pharmacy

Nelson Hardiman represents pharmacies, including retail pharmacies, compounding pharmacies, and long-term care pharmacies, in business and regulatory matters.  In addition, we represent re-packagers, pharmacy benefit managers (PBM’s), wholesalers, and individual pharmacists and pharmacy personnel.   Nelson Hardiman’s experience extends to a wide range of business, regulatory, and strategic challenges for the pharmacy industry, including:

  • Business Transactions
    • Formation of entities and business structure for pharmacy-related entities
    • Management Service Organization (MSO) relationships
    • Purchase and sale of pharmacies
  • Regulatory Defense
    • Board of Pharmacy investigations and enforcement proceedings
    • Drug Enforcement Administration (DEA) investigations, audits, and hearings
    • Food and Drug Administration (FDA) investigations and enforcement actions
    • Reimbursement recovery audits by governmental payors, including Medicare and Medi-Cal
    • Third party payor audits
  • Compliance
    • Pharmacy, PBM, and compounding compliance counseling
    • HIPAA and state patient data privacy and security requirements
  • Litigation
    • Reimbursement disputes
    • Business litigation, including partnership disputes