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The pharmaceutical industry is highly regulated, and the stakes can be high in the realm of pharmacy compliance. Whether you are a retail pharmacy or mail order pharmacy, 340B or other institutional pharmacy program, or a compounding pharmacy or pharmaceuticals wholesaler, the law firm of McBrayer has the experience and resources to protect your business.
Our lawyers focus on three main areas:
- Licensure: We help clients obtain federal and state licenses and registrations necessary to conduct their business. We also help pharmacy clients respond to inquiries, investigations and audits from the Drug Enforcement Administration (DEA) and Kentucky Board of Pharmacy and other state boards concerning licensure and registration issues.
- Compliance: We help pharmacy clients structure their business activities to comply with federal and state fraud and abuse laws, health information privacy laws, and record-keeping and notification issues.
- Reimbursements: We help pharmacy clients structure their business activities to comply with Medicare and Medicaid reimbursement requirements. We also review and negotiate pharmacy provider agreements and pharmaceutical supply agreements to help clients establish and protect reimbursement relationships.
We understand the issues that pharmacies and pharmaceutical wholesalers face. Our attorneys represent national retail pharmacies and pharmaceutical wholesalers with respect to a variety of regulatory, compliance and transactional issues. With law offices in Lexington and Louisville and a government relations practice in Frankfort, our firm represents pharmaceutical clients throughout the United States.
Take the First Step to Success
To discuss your case with one of our experienced pharmacy law attorneys, contact the firm online.
News & Insights
Seminars & Speaking Engagements
- 137th Kentucky Pharmacists Association Annual Meeting & ConventionBowling Green, KY, June 25, 2015
- Medical News, May 3, 2015
- Kentucky Board of Nursing Issues Advisory on Nurse Practitioner Prescribing During State of Emergency, Pushes Telehealth March 25, 2020
- KBML Reminds Physicians of Exceptions to Prescribing Rules for Controlled Substances During Declaration of Emergency March 20, 2020
- Healthcare Practitioners – Three Ways to Use KASPER to Protect Your Practice September 6, 2018
- Kentucky’s HB 333 and Schedule II Drug Prescriptions – What Providers Need to Know April 25, 2017
- Up, Up and Away: Penalties and CMPs to be Adjusted for Inflation November 20, 2015
- Tidbits and Takeaways from OIG’s 2016 Work Plan November 17, 2015
- KBML Issues Guidance to Help Physicians Get the Most out of MOST November 10, 2015
- OIG Alert Shows Increased Concern over Data Blocking October 27, 2015
- View More »
- Anne-Tyler Morgan - Attorney Biography
- Christopher J. Shaughnessy - Attorney Biography
- Sarah E. Hines - Attorney Biography
- Lisa English Hinkle - Attorney Biography
Who We Serve
Pharmacies of all shapes and sizes, from national chains to mail order pharmacies to the local compounding pharmacy down the street, rely on McBrayer to counsel and represent them in their highly-regulated field. We can assist clients with obtaining the appropriate facility and pharmacist licenses necessary to operate. We also represent pharmacies facing inquiries and allegations from the Kentucky Board of Pharmacy and federal programs, such as Medicare and Medicaid. Pharmacies needing to negotiate reimbursement agreements with health insurance companies can turn to us for assistance.