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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. 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 board 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

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