Based in Austin, Texas, the Texas Board of Pharmacy wields influence both within Texas and beyond its borders. As an active regulatory board, the Texas Board of Pharmacy takes its mission to protect “the public health of the citizens of Texas” and to “uphold quality standards for licensing and facilitate regulation that promotes innovative, multidisciplinary, and collaborative practices and education which produce quality care and positive patient outcomes” seriously. In pursuit of its mission, the Texas Board of Pharmacy engages in numerous functions including conducting compliance inspections, enforcement proceedings, and also in rulemaking in accordance with applicable Texas and federal law.
As a trusted pharmacy professional either located in Texas or conducting business in Texas, you recognize the importance of the Texas Board of Pharmacy’s mission and compliance with its laws, rules, and regulations. However, navigating the complexities of pharmacy law can be overwhelming, and even the most diligent professionals may encounter legal challenges with regulatory agencies and authorities like the Texas Board of Pharmacy.
With extensive experience in representing pharmacies and pharmacy professionals in Texas, Frier Levitt understands the intricacies of navigating Texas Board of Pharmacy inspections, audits, and investigations. From independent pharmacies, compounding pharmacies, and specialty pharmacies, we offer tailored legal support to pharmacy owners, pharmacists, pharmacy technicians, and other licensees.
With over two decades of experience, Frier Levitt has developed a deep understanding of intricate relationships within the pharmacy landscape. We prioritize the importance of relationships with the Board of Pharmacy (“BOP”) and other regulatory entities such as various payors, including insurance companies, pharmacy benefit managers (“PBMs”), and government payors. Importantly, we work closely with many of the attorneys who work at the various Boards of Pharmacy, including in Texas and the Texas Board of Pharmacy.
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 client’s interests.
The Relationship Between the Texas Board 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, including in Texas, often resulting in investigations mirroring PBM audits and investigations. Moreover, 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. This is certainly the case with the Texas Board of Pharmacy.
What Types of Matters Does the Texas Board of Pharmacy Investigate?
BOP inspections and investigations, including by the Texas Board of Pharmacy, 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 Attorneys Can Assist with Texas Board of Pharmacy Matters
Frier Levitt attorneys have a proven track record of handling Texas Board of Pharmacy cases including a wide range of matters ranging from licensing issues, inspections, investigations, enforcement actions, and hearings/trials. 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 personalized assistance with Texas Board of Pharmacy matters, contact Frier Levitt to speak with one of our attorneys. Your pharmacy’s future is our priority, and we’re here to safeguard your interests every step of the way. For more information on Frier Levitt’s Advertising and Labeling capabilities, contact us today.