Pharmacy Law
Licensing, compliance, audits, and defense for Tennessee’s community and compounding pharmacies, from a former state regulator with a litigation firm behind him.
Nine years inside Tennessee healthcare regulation, including as deputy general counsel at the Department of Health.
Licensed in Tennessee, with federal practice before the DEA, FDA, and HHS nationwide.
The healthcare division of Litson PLLC, ready if a matter reaches court.
What we handle
From the routine to the high-stakes, every one handled with the detail it demands.
Protecting your license when a complaint, investigation, or disciplinary action puts it at risk.
Preparing for routine inspections and standing with you through them. An inspection is a systems check, and preparation is rewarded.
Registration, audits, and controlled-substance matters before the DEA.
Responding to warning letters and Form 483 observations, and keeping your operation off the FDA’s radar.
Audit readiness, response strategy, and pushing back on reimbursement and clawback demands.
USP 800, 503A sterile and non-sterile compounding, standard operating procedures, and vendor due diligence.
Enrolling with medical carriers so you can bill as a provider, a revenue stream beyond PBM reimbursement.
Petitioning to clear old discipline from a licensee’s public record, a flat-fee project once you qualify.
Defending pharmacies and providers facing fraud allegations, billing investigations, and the exposure that comes with them.
Unlimited access to your attorney, document review, credentialing, and inspection readiness, on a predictable monthly membership instead of a meter. The heavy work that can’t be fixed-priced is always scoped up front.
From the blog
Common questions
Every level of government, local, state, and federal, has some form of inspection and investigation authority. It is important to know the differences between an inspection and an investigation, the types of records specific agencies can freely request and receive, and whether you are required to respond. We help you understand which is which before you answer anything.
Compounding is regulated at the state and federal level through a multitude of regulatory agencies, each with its own set of requirements to follow. RxLaw Group guides its clients through the dense web of regulation required to legally compound drug products, including USP 800 and 503A sterile and non-sterile compounding.
We are based in and licensed in Tennessee and advise clients across the country on the law that applies to them. With a Middle District of Tennessee admission, we also handle federal matters before the DEA, FDA, and HHS nationwide.
It means just that, unlimited access. At RxLaw Group, we believe the practice of pharmacy happens around the clock, every day of the year. For this reason, we meet our clients where they are, not on the schedule of RxLaw Group. RxLaw Group provides unlimited telephone, email, text message, video call, and face-to-face access with a healthcare law attorney for any matter covered by the scope of representation.
Talk to Matt
15 minutes with Matt Gibbs. Skip the long intake form and get a straight answer on whether we can help your pharmacy.
Schedule a free call