Pharmacy Healthcare Lawyer
Pharmacies in Florida are some of the most heavily regulated businesses in the United States. Besides various federal and state regulations and licensing, they also have significant legal liabilities and other industry specific rules. In addition to this, there are the standard business related legal concerns that need to be addressed. If not handled properly, all of these regulations and issues can be suffocating for a pharmacy and cause undue business hardship.
It is strongly recommended for those interested in starting, owning or operating a pharmacy in the State of Florida to consult with an attorney specializing in healthcare and pharmacy law. Our team of expert lawyers have decades of experience working with pharmacists as well as owners, managers and operators of retail pharmacies. If you are in need of legal advice or assistance for your pharmacy, please do not hesitate to contact us today to get started.
Establishing a Pharmacy
One of the most complicated and difficult processes involved with the retail pharmaceutical industry is the establishment of a new pharmacy. Besides the legal aspects of setting up any business, there are many pharmacy specific requirements and certifications needed in order to establish a pharmacy. Florida pharmacy permitting and inspections are primarily governed by the Florida Department of Health and Board of Pharmacy, with additional federal requirements depending on the pharmacy’s activities.
One of the first things that must be done is obtaining permits from the State of Florida. For an initial community pharmacy permit, Florida requires a satisfactory onsite inspection before issuing the permit. Once the appropriate state permit is obtained, pharmacies intending to handle controlled substances must also obtain DEA registration. Medicare, Medicaid, and other insurance program participation may involve separate enrollment or contracting requirements. A pharmacy can begin operations once it has satisfied all applicable licensing, registration, and operational requirements.
Working with an attorney during the startup phase of a pharmacy is critical to ensuring not only its compliance with a plethora of legal requirements but also to ensure its long term business success. Our expert attorneys work with a variety of different types of pharmacies from independent and single location operations to large scale chain pharmacies with multiple locations.
Buying or Selling a Pharmacy in Florida
Buying or selling a pharmacy involves legal and regulatory considerations beyond a typical business transaction. Pharmacy owners and prospective buyers must address licensing requirements, purchase agreements, regulatory compliance, and the transfer of prescription records and inventory.
Under Florida law, a change of pharmacy ownership generally requires a new pharmacy permit. Transactions involving controlled substances may also trigger separate DEA registration and inventory requirements. Failing to address these obligations before closing can create delays or disrupt pharmacy operations.
The healthcare attorneys at Di Pietro Partners assist pharmacy owners and prospective buyers with business transactions, regulatory due diligence, licensing considerations, and compliance issues associated with pharmacy ownership changes.
Operation and Compliance
While the startup of a pharmacy is the most complex and challenging legal aspect of the business, operating and managing a pharmacy can involve many legal issues. One of the largest issues faced by pharmacies is regulatory compliance violations and license suspensions or revocations. These can occur due to improper employee training, or as a result of honest mistakes or misunderstandings.
Many of these issues can be avoided with proper training and guidance from attorneys specializing in healthcare and pharmacy law. Florida community pharmacies must develop and maintain current policies and procedures, not simply prepare them for the initial permitting inspection. Regular staff training also helps ensure these procedures remain effective throughout the pharmacy’s operations. This continuing education helps to ensure ongoing compliance with state, DEA, HIPAA and CMS regulations. Our attorneys can help to craft these policy and procedural manuals, as well as offer assistance in the design of ongoing educational courses.
Why Choose Di Pietro Partners for Pharmacy Healthcare Law?
Pharmacy owners face legal challenges that extend beyond regulatory compliance. Licensing disputes, DEA investigations, business transactions, and reimbursement issues can all affect a pharmacy’s financial stability and ability to operate. Di Pietro Partners brings together healthcare law, business law, and litigation experience to help clients navigate these challenges.
Healthcare and Business Law Experience
Di Pietro Partners represents healthcare providers in regulatory investigations, licensing disputes, business transactions, and healthcare litigation. This combination allows our attorneys to evaluate pharmacy-related legal matters from both a regulatory and business perspective, considering how legal decisions may affect day-to-day operations and long-term financial interests.
Extensive Litigation and Trial Experience
Founder and Managing Partner David Di Pietro has more than 20 years of litigation experience, including over 70 jury trials. As a former Assistant State Attorney, he also brings a background in evaluating evidence and handling contested legal proceedings. This experience informs the firm’s representation of healthcare businesses facing regulatory disputes and potential litigation.
Firsthand Healthcare Leadership Experience
David previously served as Chairman of the North Broward Hospital District, which governs Broward Health. His leadership experience provides firsthand insight into healthcare operations, institutional compliance, regulatory oversight, and the challenges facing healthcare organizations.
Prescription Department Manager Requirements in Florida
Florida pharmacies must designate a qualified pharmacist to oversee their prescription department. The Prescription Department Manager (PDM) is responsible for maintaining required drug records, ensuring the security of the prescription department, and overseeing compliance with applicable pharmacy laws and regulations.
Changes in pharmacy management can also trigger reporting obligations. Under Florida Statutes § 465.022, community pharmacies must notify the Florida Department of Health within 10 days of a change in their Prescription Department Manager. Failure to comply with applicable management and reporting requirements may expose pharmacy owners and pharmacists to regulatory scrutiny or disciplinary action.
Di Pietro Partners assists pharmacy owners and operators with management transitions, regulatory compliance, licensing issues, and disputes involving the Florida Board of Pharmacy.
Controlled Substance Dispensing and DEA Compliance
Florida pharmacies that dispense controlled substances must comply with federal and state requirements governing prescription verification, inventory management, recordkeeping, and diversion prevention.
Under 21 CFR § 1306.04, pharmacists have a corresponding responsibility to ensure that controlled-substance prescriptions are issued for a legitimate medical purpose in the usual course of professional practice. Pharmacies must also maintain accurate controlled-substance inventories and comply with applicable requirements for reporting theft or significant losses.
Violations involving improper dispensing, suspicious prescription activity, missing inventory, or inadequate recordkeeping can expose pharmacies to DEA investigations, regulatory penalties, and potential registration actions. Di Pietro Partners assists pharmacy owners and pharmacists with controlled-substance compliance concerns, regulatory investigations, and enforcement matters that threaten their professional and business interests.
Investigations and Disciplinary Actions
Unfortunately, pharmacies may face disciplinary action against their Florida pharmacy permits through the Florida Department of Health or Board of Pharmacy, as well as separate DEA enforcement actions involving their federal controlled-substance registrations. These are serious situations and it is vital that they are handled appropriately to minimize their damage to the business. In addition to this, these agencies also conduct investigations and audits, which open a pharmacy up to possible litigation and disciplinary action.
Outside of agencies directly involved in the regulation of pharmacies, there are other parties that can be involved in the investigation and auditing of pharmacies. Conducted by Medicare, medicaid and other third party payor auditors, these audits and investigations can cause issues surrounding deficiencies and over payment demands. These issues should not be overlooked as they can cause pharmacies a considerable amount in fines, fees and lost revenue from payment mismanagement.
Because of the serious impact that investigations, audits and disciplinary actions can have on a pharmacy, it is strongly recommended to work with an attorney specializing in pharmacy law. Experienced legal representation can help pharmacies respond to regulatory challenges, address potential violations, and protect their ability to continue operating. Our pharmacy lawyers have years of experience working with pharmacies and regulatory agencies to resolve disputes, respond to enforcement actions, and pursue favorable outcomes while protecting our clients’ business interests.
Pharmacy Benefit Manager (PBM) Audits and Reimbursement Disputes
Pharmacy benefit managers (PBMs) play a significant role in pharmacy reimbursement and prescription drug coverage. Disputes involving PBMs can create serious financial and operational challenges for independent pharmacies and larger pharmacy businesses.
Common issues include pharmacy audits, reimbursement disputes, payment recoupment demands, contractual disagreements, and potential termination from pharmacy provider networks. Florida law establishes requirements for certain pharmacy audits and regulates various PBM practices, providing pharmacies with important protections and avenues for challenging certain audit findings.
Di Pietro Partners assists pharmacies with regulatory and business disputes, including reviewing audit findings, evaluating contractual obligations, responding to payment disputes, and assessing available legal remedies. Early legal guidance can help pharmacy owners protect their financial interests and address disputes that threaten their business operations.
Speak With a Florida Pharmacy Healthcare Lawyer
Owning and operating a pharmacy involves complex legal, regulatory, and business responsibilities. Whether you are establishing a new pharmacy, navigating licensing requirements, responding to a regulatory investigation, or facing a pharmacy audit or reimbursement dispute, experienced legal guidance can help protect your business and professional interests.
Di Pietro Partners assists pharmacy owners and operators with management transitions, regulatory compliance, licensing issues, and disputes involving the Florida Board of Pharmacy. When a complaint threatens an individual pharmacist’s professional license, our attorneys also provide pharmacist licensure defense representation.
Contact Di Pietro Partners today to schedule a confidential consultation with a Florida pharmacy healthcare attorney.
