DEA & Controlled Substances
DEA registration, inspections and accountability audits, recordkeeping, CSMD obligations, and dispensing questions for Tennessee pharmacies, from a former state regulator with a litigation firm behind him.
Eleven 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.
How we approach it
When DEA diversion investigators visit a pharmacy, the core of the visit is an accountability audit, which takes a beginning inventory, adds what was received, subtracts what was dispensed, and compares the result to what is on the shelf, and every gap in that arithmetic becomes a question the pharmacy has to answer. Matt Gibbs spent more than eleven years inside Tennessee healthcare regulation, including as deputy general counsel at the Department of Health, and he approaches controlled substance matters the way the investigators do, by starting with the records and working outward to the explanation, because an explanation that the records cannot support rarely satisfies anyone.
Investigators are doing careful work, and a pharmacy that keeps its inventories, invoices, dispensing records, and CSMD reporting in order gives them very little to find. The preparation side of this practice is a review of those systems before anyone asks to see them, along with the dispensing policies that document how the pharmacy resolves the red flags every pharmacist is trained to notice, so that the judgment calls made at the counter are supported by a record that explains them. That preparation is what turns an inspection into a systems check rather than an investigation, and it is the part of the practice that pays for itself most quietly.
When an inquiry does arrive, whether it is a records request, an audit finding, or a question about a registration, the response is prepared with the same discipline, and the litigation firm behind RxLaw Group is there for the matters that escalate. Telehealth prescribing adds its own layer, since the federal flexibilities that allow controlled substances to be prescribed by telemedicine currently run through the end of 2026 and a permanent registration rule is still pending, so we help pharmacies fill those prescriptions with a process that will hold up as the law changes, rather than one that has to be rebuilt each time it does.
What we handle
From the registration application to the audit closeout, and the records that keep both uneventful.
New applications, renewals, modifications, and the questions that come up when a registration is under review.
Preparing the pharmacy before a DEA visit and standing with you through the audit so the count and the record agree.
Biennial inventories, invoices, dispensing records, theft and loss reporting, and the systems that keep them audit-ready.
Tennessee Controlled Substance Monitoring Database reporting and checking obligations, and the documentation behind them.
Corresponding responsibility, red-flag resolution, and written policies that support the judgment calls made at the counter.
Filling telemedicine prescriptions for controlled substances under the current federal flexibilities, with a process built to outlast them.
An active DEA inquiry, audit finding, or registration proceeding is handled on an hourly or retainer basis with a clear scope and estimate before work begins. Members get the preparation that keeps the count and the record in agreement: unlimited questions, recordkeeping and dispensing policy review, and inspection readiness on one flat monthly fee.
Common questions
Investigators typically present their credentials and a notice of inspection, review the registration and security of the controlled substance storage, and then conduct an accountability audit that compares the inventory on hand with what the records say should be there. They may also ask about dispensing practices and specific prescriptions. Cooperating is the right instinct, and having counsel involved early keeps the record of what was reviewed and said accurate and complete.
At a minimum, a pharmacy needs its DEA registration, biennial inventory, receiving records and invoices, dispensing records, records of theft or loss, and documentation of any transfers or disposals, kept for the periods the law requires and readily retrievable. Tennessee adds CSMD reporting and checking obligations on top of the federal requirements. Reviewing those systems before an audit is far easier than reconstructing them during one.
Membership covers the questions, recordkeeping and policy review, and inspection preparation that surround a controlled substance matter, and it is the reason most members find a DEA visit uneventful. An active investigation, audit finding, subpoena response, or registration proceeding is a separate engagement, scoped and estimated up front on an hourly or retainer basis, so there is never a surprise about what is covered.
Under the federal telemedicine flexibilities currently in place, which run through the end of 2026, many telehealth prescriptions for controlled substances can be filled, but the pharmacist’s corresponding responsibility applies in full and the rules are expected to change once a permanent special registration framework is finalized. A written process for evaluating and documenting these prescriptions is the best protection while the law is in motion.
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