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OVERVIEW

Pharmacy Regulatory Compliance Better health

The attorneys in Barnes & Thornburg Healthcare Department help pharmacy clients - including but not limited to retail, institutional and specialty pharmacies - manage regulatory compliance related to the sale, transfer, distribution, dispensing and administration of prescription drugs.

Pharmacy Licensing, Dispensing, Pricing and Reimbursement

Our healthcare attorneys advise pharmacy clients and pharmacy professionals on regulations associated with the flow of drugs from manufacturers, wholesalers and pharmacies to physicians, hospitals and/or patients.

We help pharmacies comply with virtually all licensing and other regulations inherent in the dispensing or administration of prescriptions drugs, including but not limited to:

  • Licensing requirements necessary to the operation of their pharmacies at the board, state and federal levels
  • Pharmacy law with respect to stocking, dispensing and pricing of drugs
  • Rules governing reimbursements, including Medicare and Medicaid reimbursement issues
  • Confidentiality issues (e.g., HIPAA audits or compliance programs)
  • Representation before state licensing boards and other regulatory bodies governing retail, wholesale pharmacy practices and procedures
  • Therapeutic substitutions issues
  • Comprehensive advice for maintaining compliance with relevant FDA, DEA, CDC, boards of pharmacies, and other relevant licensing board laws and regulations

Administering Drugs, Therapeutic Services, or Other Healthcare Services

We help pharmacies design programs to comply with the complex chain of state and federal regulations involved in administering drugs, providing therapeutic services, and promoting the education of pharmacy customers. We also counsel clients on establishing the necessary protocols with third-party providers. We assist pharmacy professionals with:

  • Pharmacy Practice Act licensing requirements for pharmacies and pharmacists and anyone else engaged by the pharmacy in connection with pharmacy-sponsored programs
  • Counseling and advice on services provided directly to patients by pharmacies, such as programs for flu shots, testing services, diabetes education programs)
  • Counseling and advice on necessary protocols with physicians for certain medical management services and with relationships to other service providers
  • Laboratory licensing requirements, including state and federal licensing, Clinical Laboratory Improvement Amendments (CLIA) requirements

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