State Board of Pharmacy Investigations, Inspections, and Other Related Matters
As a trusted pharmacy owner or pharmacist, you may understand the importance of compliance with your state’s Board of Pharmacy (BOP) 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 BOPs. Frier Levitt attorneys regularly represent pharmacies, pharmacists and pharmacy owners in connection with BOP matters and other related agencies. Frier Levitt also has experience defending pharmacies, pharmacists, pharmacy technicians, and pharmacy owners in Board inspections, audits, investigations, and at hearings.
As a national healthcare, life sciences and pharmacy 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 understands the complexities of the healthcare ecosystem. We cultivate productive relationships with BOPs and other key regulatory entities such as various payors including insurance companies, pharmacy benefit managers (“PBMs”), and government payors—to help clients navigate compliance, mitigate risk, and achieve favorable outcomes.
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
BOPs are increasing oversight of pharmacies and pharmacists in response to patient-safety concerns related to issues like the opioid crisis, telemedicine, and questionable marketing practices. Working with other state agencies, and even private actors like PBMs, BOPs conduct comprehensive inspections and investigations that may involve subpoenas and extensive records requests. Focus areas commonly include:
- Core pharmacy operations and staffing adequacy
- Prescription sourcing and verification
- Marketing arrangements and practices
- Pharmacy management agreements
- Copay collection and billing practices
If your pharmacy is inspected or investigated by a BOP—or any state agency—retaining experienced counsel early is critical. Proactive compliance measures can also reduce the risk that routine inspections escalate into disciplinary actions.
Frier Levitt helps pharmacies navigate BOP inquiries from start to finish, including:
- Immediate response to inspections, subpoenas, and records requests
- Representation during interviews, on-site inspections, and hearings
- Review and remediation of policies, procedures, and agreements
- Compliance audits and staff training to prevent future issues
- Strategic resolution of alleged violations and negotiation of outcomes
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. 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
How Frier Levitt Can Help
Our 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. Your pharmacy’s future is our priority, and we’re here to safeguard your interests every step of the way.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
