Pharmacies and pharmacy professionals turn to us for guidance on regulations associated with the flow of drugs from manufacturers, wholesalers and specialty pharmacies to physicians, hospitals and patients.
Because our experience is broad and deep, we advise on an array of legal issues associated with the wholesale and retail pharmacy industry, such as
- Board, state and federal licensing requirements necessary to pharmacy operations
- Pharmacy law with respect to the stocking, dispensing and pricing of drugs
- Rules governing reimbursements, including Medicare and Medicaid
- Confidentiality issues such as HIPAA audits and compliance programs
- Representation before state regulatory bodies governing retail and wholesale pharmacy practices and procedures
- Therapeutic substitutions
- Maintaining compliance with FDA, DEA, CDC and other relevant licensing board laws and regulations related to administering drugs, therapeutic services and other healthcare services
Our firm is called upon to advise pharmacy professionals with Pharmacy Practice Act licensing requirements for pharmacies, pharmacists and anyone else engaged by the pharmacy in connection with pharmacy-sponsored programs. We counsel clients on services provided directly to patients, including vaccinations, testing services and diabetes education programs. We deliver actionable advice on the necessary pharmacy protocols for certain medical physician practice management services and other service providers. Moreover, clients turn to us for representation involving state and federal licensing and Clinical Laboratory Improvement Amendments (CLIA) requirements.