Pharmacy, Drug and Device

Pharmacy lawyers deeply rooted in the complex pharmacy world

Capabilities at a glance

  • Nationally recognized legal counsel, representing clients before all 50 state boards of pharmacy.
  • Our attorneys are active thought leaders, regularly presenting on topics impacting the industry to national pharmacy trade groups as well as at our annual Pharmacy Law Symposium.
  • Providing deep bench strength within a stable yet growing team, making sure we assemble the right mix of experience levels, knowledge and diversity to help our clients succeed.
  • Keeping you on top of regulatory requirements and compliance obligations, so you can focus on doing what you do best.

Shared purpose with clients on pharmacy, drug and device law

Quarles is one of the premier pharmacy law groups in the country. That’s because our attorneys are deeply connected to the pharmacy world. Several attorneys are licensed pharmacists, bringing a true insider’s perspective to our client work. We have deep-seated, decades-long relationships with state board of pharmacy regulators in all 50 states — relationships that benefit our clients greatly. We regularly influence and modify pharmacy-related legislation that could adversely affect our clients’ business operations. Even our thought leadership has shaped regulatory decisions: A client alert published by our team completely changed the course of a state board’s decision on a key licensing issue affecting certain pharmacies in Texas. When necessary, our attorneys formally challenge regulations in court and aggressively litigate to protect and defend our pharmacy clients. 

Legal excellence and extensive pharmacy industry experience

Our Pharmacy Law team represents pharmacies of all kinds, discount medical plan organizations (DMPO), third-party administrators (TPA), drug and device manufacturers and other pharmaceutical companies. In addition to representing clients before all 50 state boards of pharmacy, we help our pharmacy clients in a wide variety of areas such as 340B, DEA compliance, specialty pharmacy, drug and device distribution, licensing, veterinary pharmacy, FDA regulatory matters, pharmaceutical manufacturing, HIPAA and privacy, and mergers and acquisitions (M&A). To comprehensively serve our pharmacy clients’ needs, our team often collaborates with other Quarles attorneys with experience in general litigation, intellectual property, tax, labor and employment, employee benefits and insurance regulation.

Quarles is approved through the National Association of Boards of Pharmacy® (NABP) Pharmacy Verified Websites Program, demonstrating the firm's commitment to the highest ethical standards.

Experience

  • State boards of pharmacy representation
  • Regulatory compliance
  • Regulatory inquiries and investigations
  • State licensing, including new pharmacy locations
  • Medicare and Medicaid regulations and requirements
  • Medical discount card regulation and contracting
  • Fraud and abuse issues
  • Prescription drug pricing, including formularies, rebates, other payments and switching programs
  • Prescription medication billing issues, including auditing of pharmacies, developing internal audit procedures, corporate compliance guidelines and compliance education
  • Reporting requirements
  • Pharmacy billing and coding practices

Successes

  • Our Pharmacy Law team helped numerous mail order pharmacies draft, lobby and pass legislation to allow remote work in Kentucky. While two pharmacies championed the work, the original legislation potentially impacted operations of every mail order and retail pharmacy in Kentucky. Our lead attorney worked directly with our pharmacy clients and lobbyists to educate legislators, go through all revisions and ultimately pass legislation to protect remote pharmacy workers.
  • Our attorneys represented a regional pharmacy in its pharmacy expansion efforts into additional states, including establishing the entities, licensure and all aspects of regulatory compliance. In addition, we advise on an ongoing basis regarding the pharmacy's formulary, telemedicine relationship issues and national compliance strategy.

News & Insights

To Be or Not To 340B Blog

Read more at our To Be or Not To 340B Blog

Service Areas

  • 340B

    Our team has extensive experience guiding clients through the complex world of the 340B drug pricing program. Our experience extends to representing nearly every category of stakeholder involved in the 340B program, including hospital covered entities, grantee covered entities, contract pharmacies, third-party administrators (TPA), manufacturers, pharmacy benefit managers (PBM) and drug wholesalers. This well-rounded experience informs the holistic and practical nature of our 340B advice, ensuring that any proposed actions or procedural changes are made with the full picture in mind. More specifically, we routinely assist covered entities in complying with their reporting, enrollment, audit and other regulatory obligations related to the 340B program, ranging from general compliance with federal 340B requirements to more granular compliance with state-level Medicaid billing and general board of pharmacy regulations. We also assist covered entities in developing creative, compliant strategies for 340B program optimization to ensure the maximum available 340B benefit for their patient population, including coordinating with TPA partners to determine the most beneficial eligibility configuration settings to maximize compliant capture of 340B claims.

    On the pharmacy side, we frequently work with contract pharmacies to negotiate 340B contract pharmacy agreements that enable both covered entities and the contract pharmacies to obtain 340B program benefits and maintain program compliance. We also work with PBMs as they expand their pharmacy network and pharmacy services agreements to include the provision of 340B pharmacy services and navigate state-level restrictions on 340B program reimbursement. In addition to our experience with the 340B program specifically, our team has a deep bench of experienced pharmacy lawyers who can ably identify and resolve pharmacy issues adjacent to the 340B program.

    Read more at our To Be or Not to 340B Blog.

    Please contact Brenda Shafer, Richard Davis and Michael French for more information.

  • DEA Compliance and Litigation

    DEA compliance is complex, costly and not without substantial risk, and our DEA Compliance and Litigation team can support you in any eventuality. We have extensive experience helping our pharmaceutical and health care clients fulfill their obligations under the Controlled Substances Act (CSA) and DEA’s implementing regulations, including conducting comprehensive reviews of policies and procedures, developing training programs and ensuring compliance with registration, recordkeeping and reporting requirements. We also represent clients in responding to and managing investigations and litigation regarding alleged violations of the CSA and DEA regulations. Our attorneys are committed to developing our clients into industry leaders in DEA compliance, while facilitating innovation in the delivery of controlled substances and listed chemicals throughout the supply chain.

  • Drug and Device Distribution

    We serve as national regulatory counsel for a number of manufacturers, wholesalers and third-party logistics (3PL) providers of human and animal prescription and over-the-counter drugs and devices, in addition to durable medical equipment providers. We advise on regulations and requirements regarding operations, state licensing and reporting requirements, and guide clients through what can often be challenging regulatory inquiries and investigations. We can assist you with all areas of drug and device distribution law from the beginning of your business. In addition to providing strategic regulatory compliance advice, we assist clients with the licensing of their facilities at initial startup or as a result of changes of ownership triggered by reorganizations or mergers and acquisitions (M&A). We also support our clients with M&A itself and have helped multiple clients acquire or sell drug and device distribution facilities and complete the necessary internal corporate restructuring.

  • FDA Regulatory Practice

    Quarles’ Food and Drug Administration (FDA) attorneys provide counsel on pharmaceuticals, medical device development, dietary supplements, biotechnology, food and beverage, cosmetics and all other regulatory areas that are subject to the jurisdiction of the FDA. We also represent clients before related regulatory agencies, including the Center for Medicare and Medicaid Services (CMS), the Consumer Product Safety Commission (CPSC), the Drug Enforcement Administration (DEA), the Environmental Protection Agency (EPA) and the Federal Trade Commission (FTC). Our goal is to provide specialized, strategic guidance and service to clients through all manner of regulatory compliance issues and during every stage of the development, approval and marketing process, including clinical trials, advertising and promotion, and the distribution chain.

  • Licensing

    Over decades, Quarles has grown its licensing practice to provide a full suite of services. Our licensing team understands the extensive and unique reporting requirements applicable to health care entities of all types, including pharmacies, wholesalers, 3PLs, repackagers, 503B outsourcing facilities, PBMs, DMEPOS suppliers, hospitals, clinics, home health agencies, hospice, long-term care, behavioral health and many more. We assist these clients with areas such as changes of ownership (CHOW), relocations, reorganizations, expansions/de novos and rebranding. Our experience with the various regulatory agencies that govern your business and our relationships with the licensing boards, DEA, state Medicaid Programs, Centers for Medicare and Medicaid Services (CMS), regional offices (RO) and Medicare Administrative Contractors (MAC) offer a comprehensive and integrated approach to accomplish your business goals. We work with both independents and pharmacy networks comprised of hundreds of locations.

    For more information, please contact Anne O'Brien.

  • Specialty Pharmacy

    Quarles has been representing pharmacies for decades and understands that specialty pharmacy is a unique area of business. We provide real-world legal advice on issues ranging from risk evaluation and mitigation strategies (REMS) to accreditation, the federal Anti-Kickback Statute (AKS) to adherence programs, and licensing to 340B issues and data-use agreements. We understand how your industry works because we are intimately connected to it. Our team of specialty pharmacy attorneys includes five attorneys who started their professional careers as pharmacists, one of whom was the owner of an independent pharmacy, a former nurse and a former pharmacy technician. We cultivate meaningful relationships with regulators and are actively involved in industry organizations. In addition to specialty pharmacies, we also represent payors, prescribers, manufacturers and pharmacists. The team's ability to combine multiple industry perspectives with decades of legal experience enables us to provide exceptional strategic counsel and help clients achieve their long-term objectives.

  • Veterinary Pharmacy and Wholesale Distribution

    Our pharmacy team has wide-ranging experience with licensing new veterinary pharmacy, mobile clinics and wholesale distribution locations, as well as advising clients on the necessary staffing, operational and systems requirements for these locations. While some states require veterinary pharmacies to obtain certain classifications on their permit, others exempt veterinary pharmacies from many regulatory requirements. In addition to advising on the distribution of prescription drugs, our attorneys support clients on the distribution of prescription pet food, commercial feed, medicated feed and pet treats. Our clients ship these products not only to pet parents, but also to farms, racetracks, animal shelters and clinics across the country. Although veterinary pharmacies are regulated by state boards of pharmacy, we have interacted with various state veterinary boards to help influence pharmacy regulations in support of the veterinary industry. We have also helped many veterinary pharmacies and distributors expand their business through the use of new technology, including innovative databases and veterinary telemedicine.

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