Board of Pharmacy Attorneys | Frier Levitt
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State Board of Pharmacy Investigations, Inspections, and Other Related Matters

As a trusted pharmacy owner or pharmacist, you understand the importance of compliance with your state’s Board of Pharmacy regulations. However, navigating the complexities of pharmacy law can be daunting, and even the most diligent professionals may find themselves facing legal issues with regulatory agencies and authorities including Boards of Pharmacy. Frier Levitt attorneys regularly represent pharmacies, pharmacists and pharmacy owners in connection with Board of Pharmacy matters and other related agencies. Frier Levitt also has experience defending pharmacies, pharmacists, and pharmacy owners in Board inspections, audits, and investigations.

As a national healthcare and life sciences boutique law firm, Frier Levitt has vast experience representing all types of licensed healthcare and life sciences professionals.  From independent pharmacies, compounding pharmacies, and specialty pharmacies, we offer tailored legal support to pharmacy owners, pharmacists, pharmacy technicians, and other licensed dispensing practitioners.

With over two decades of experience, Frier Levitt has developed a deep understanding of intricate relationships within the healthcare landscape. We prioritize the importance of relationships with State Boards of Pharmacy (BOP) and other regulatory entities such as various payors including insurance companies, pharmacy benefit managers (“PBMs”), and government payors.

We recognize the many implications arising from BOP matters, including inspections and investigations and other entities that are crucial to the overall success and ability of pharmacies and pharmacists to practice confidently. 

Evolving Oversight by State Boards of Pharmacy

Amid growing concerns surrounding issues like the opioid epidemic, telemedicine and questionable marketing practices, BOPs have intensified their scrutiny and oversight of pharmacies and pharmacists due to considerations for patient safety. Collaborating with other state investigative agencies, BOPs conduct thorough inspections and investigations into various aspects, including basic pharmacy operations, assessing the adequacy of pharmacy personnel, prescription sourcing, marketing arrangements and practices, pharmacy management agreements, and copay collection practices. Such investigations will often include subpoenas and other invasive records requests. Given this challenging and evolving legal landscape, it is important to ensure that if a pharmacy, pharmacist, or pharmacy technician is being inspected or investigated by a BOP (or any other agency), that competent legal counsel is retained to navigate the proceeding prudently. There are also numerous proactive measures that a pharmacy or pharmacist can undertake to ensure that more routine inspections and interactions with BOPs do not result in issues that lead to more serious proceedings including disciplinary actions. Frier Levitt provides adept legal counsel to navigate these investigations effectively, ensuring the protection of our clients’ interests.

Relationship Between State Boards of Pharmacy and Pharmacy Benefit Managers

The influence of PBMs in the pharmacy marketplace cannot be overstated. Over the past several years our team has observed a growing collaboration between PBMs and BOPs, often resulting in investigations mirroring PBM audits and investigations. Disciplinary Action by one BOP can lead to disciplinary action by BOPs in other jurisdictions. Further, Disciplinary Action by even one BOP can lead to PBMs attempting to terminate a pharmacy’s contractual relationship between the PBM and the pharmacy. A pharmacy or pharmacist’s dealings and interactions with BOPs cannot be taken lightly or handled haphazardly—they must be approached with utmost seriousness and caution.

What Types of Matters Do State Boards of Pharmacy Investigate?

BOP investigations range in complexity from straightforward administrative issues to serious allegations of fraud and patient safety concerns. Examples include:

  • Pharmacy’s Overall Dispensing Practices
  • Pharmacy’s Staffing Ratios and Minimum Staffing Requirements
  • Drug Inventory Discrepancies and Inventory Shortfalls
  • Pharmacy’s Prescription Transfer Policies, Practices and Procedures
  • Failure to Provide BOPs with Notice of Changes:
  • Location, Ownership, Pharmacist-in-Charge (PIC), etc. 
  • Failure to Provide BOP with Notice of Disciplinary Action in other Jurisdictions
  • Practice of Pharmacy by Unlicensed Individuals or Unqualified Individuals
  • Pharmacy Minimum Hours of Operation and “Failure to Operate”
  • Pharmacy Supervision of Pharmacy Personnel
  • Pharmacy Business Practices including Marketing Practices, Arrangements, and Agreements
  • Pharmacy Inventory Maintenance, Storage Practices, and Security Policies
  • HIPAA Breaches
  • Patient Complaints
  • Prescriber Complaints
  • Recordkeeping Requirements and Storage/Maintenance of Prescription Records
  • Pharmacy Policies and Procedures Including handling of Controlled Dangerous Substances
  • Pharmacy Policies and Procedures Related to Mailing or Mail-Order Pharmacy, Delivery Services, and Shipping

Frier Levitt Attorneys Can Help with Board of Pharmacy Matters

Frier Levitt attorneys have handled numerous BOP licensing issues, BOP inspections, BOP investigations, BOP enforcement actions, and other related BOP matters in many jurisdictions throughout the country. Frier Levitt has a multi-disciplinary team of attorneys including pharmacist-attorneys, experienced litigators with extensive trial experience, criminal defense attorneys, and attorneys with vast experience dealing with PBMs, all of whom are prepared to represent and defend pharmacies and pharmacists throughout all aspects of a BOP investigation, including, if necessary, at hearings or trials. Our goal is to ensure that the rights and interests of the pharmacy or pharmacist are defended throughout the proceeding while that every effort is made to achieve the best result possible given the unique circumstances of the case. Where Disciplinary Action is involved or occurs, we work closely with the pharmacy and/or pharmacist(s) to ensure compliance with all applicable rules and regulations for BOPs and PBMs to avoid further issues. For more information on how we can assist you with BOP matters, contact Frier Levitt to speak with an attorney.  Your pharmacy’s future is our priority, and we’re here to safeguard your interests every step of the way.

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