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Remain calm and immediately notify counsel
Contact experienced DEA counsel at the outset. Do not make assumptions, admissions, or informal explanations before the scope of the inspection is understood.
Whether you are facing a DEA inspection, administrative subpoena, search warrant, or Controlled Substances Act violations, Health Law Alliance provides experienced DEA defense counsel when your registration and practice are at risk. Our attorneys have successfully defended providers against allegations of recordkeeping violations and improper prescribing practices, defeated Orders to Show Cause in DEA administrative courts, won lawsuits against the DEA in federal court, and helped providers around the country maintain their DEA registration.
A DEA inspection can rapidly escalate from a routine review into an enforcement matter that jeopardizes a registrant’s ability to prescribe, dispense, administer, distribute, or otherwise handle controlled substances. Investigators may begin with inventories, DEA Forms, prescription records, security measures, or dispensing practices, but perceived discrepancies can lead to allegations of recordkeeping violations, unresolved red flags, diversion, an Immediate Suspension Order, or proceedings to revoke the DEA registration.
Our DEA defense attorneys represent pharmacies, physicians, clinics, and other DEA registrants in DEA inspections, diversion investigations, Orders to Show Cause, Immediate Suspension Orders, and other DEA proceedings. We act quickly to assess the Agency’s concerns, protect the record, and develop a strategic response designed to preserve your DEA registration and your ability to prescribe, dispense, administer, distribute, or otherwise handle controlled substances.
Health Law Alliance intervenes early to take control of the DEA inspection or investigation before it escalates. Our attorneys manage communications with DEA personnel, assess the scope and legal consequences of inspection and/or document demands, review records before production where appropriate, and challenge the factual basis for alleged inventory shortages, recordkeeping deficiencies, prescribing concerns, and diversion allegations.
When DEA seeks to restrict, suspend, deny, or revoke a registration, our experienced healthcare defense attorneys represent registrants in Orders to Show Cause, Immediate Suspension Order proceedings, and related litigation as well as state board actions. We build a focused defense alongside a practical corrective-action plan designed to address legitimate concerns, protect the practice’s ability to handle controlled substances, and minimize the consequences of alleged violations of the Controlled Substances Act, DEA regulations, and applicable state laws.
Health Law Alliance’s DEA defense team is led by Diana Yastrovskaya and Anthony Mahajan and works closely with Nancy Coffey, a former DEA Diversion Program Manager with over 30 years of experience. Ms. Coffey brings an Agency-informed understanding of DEA policy, DEA inspection practices, and DEA’s compliance requirements developed through years of direct responsibility within the DEA. Her perspective helps our DEA defense team anticipate the issues DEA investigators are likely to examine, assess the significance of alleged deficiencies, and develop a focused defense and compliance strategy.
Notably, a DEA inspection or investigation rarely exists in isolation. What begins as a review of controlled-substance records can jeopardize a provider’s DEA registration and professional license, trigger parallel licensing board proceedings, including Board of Pharmacy proceedings and, in more serious cases, lead to a DEA criminal or civil investigation. With those collateral consequences in view from the outset, our DEA defense team evaluates every document production, statement, corrective-action proposal, and potential resolution across all potential matters, so that a response intended to resolve one issue does not create unnecessary exposure in another forum.
A DEA inspection is a high-stakes regulatory event, not a routine audit. The manner in which a pharmacy, healthcare practice, clinic, or other DEA registrant responds in the first hours can shape the Agency’s view of the matter and affect the registrant’s DEA registration, professional license, and ability to continue handling controlled substances.
This checklist identifies the ten immediate steps HLA’s DEA defense team recommends healthcare providers take to preserve the record, protect the registrant’s rights, manage the inspection lawfully and professionally, and prevent avoidable issues from escalating into a DEA enforcement action.
Contact experienced DEA counsel at the outset. Do not make assumptions, admissions, or informal explanations before the scope of the inspection is understood.
Request and document each investigator’s name, agency, badge number, and contact information. Determine whether the inspection is administrative, investigative, or pursuant to a warrant.
Confirm whether DEA is relying on a signed administrative inspection warrant, voluntary consent, a valid DEA inspection notice, or another asserted authority. Do not consent to an expanded search without consulting counsel.
Assign a knowledgeable representative, ideally the Pharmacist-in-Charge, practice manager, compliance officer, or owner, to coordinate communications, accompany investigators, and maintain an accurate record of all requests.
Record the date and time of arrival, each investigator present, every area inspected, records requested or reviewed, questions asked, statements made, and any documents or items copied, photographed, or seized.
Immediately preserve controlled-substance records, inventories, invoices, dispensing logs, prescription files, electronic data, security footage, policies, employee communications, and related materials. Do not alter, destroy, backdate, or “clean up” records.
Provide only records that are requested and legally required or authorized. Keep complete copies of every item produced, identify the source of each record, and use a production log for electronic and hard-copy materials.
Instruct employees to be courteous and truthful, but not to speculate, guess, or volunteer information outside the question asked. Employees should promptly refer substantive legal, compliance, or operational questions to the designated representative and counsel.
If DEA conducts an inventory or reviews controlled-substance stock, have an appropriate staff member observe the process. Reconcile the DEA’s count against the practice’s records and document any discrepancies or methodology concerns immediately.
Debrief with counsel and key personnel after the inspection. Review any DEA-issued forms, receipts, notices, requests for records, or alleged discrepancies; preserve deadlines; and prepare a timely, accurate response or corrective-action plan where appropriate.
Do NOT sign a Form 104 voluntary surrender at DEA’s request during an inspection or follow-up visit. Once surrendered, the registration is terminated and the decision is nearly impossible to undo.
Before you make statements, sign an agreement, or take corrective action, speak with experienced counsel. HLA will assess the inspection, scrutinize the evidence, and direct a coordinated response to the DEA and any related regulatory, civil, or criminal proceeding.
A DEA inspection can reach far beyond a physical count of controlled substances. Depending on the registrant, the activities at issue, and the authority DEA is relying upon, investigators may examine virtually every aspect of the practice’s controlled-substance operations, including but not limited to:
Depending on the facts and the applicable proceedings, a registrant may face:
Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.
Prior results do not guarantee a similar outcome.
Health Law Alliance has successfully defended healthcare clients in high-stakes DEA enforcement matters.
Health Law Alliance secured the rescission of an Order to Show Cause during administrative proceedings and ended a contested DEA Tribunal hearing.
HLA filed an emergency federal action after DEA issued an Immediate Suspension Order, resulting in dismissal of the pending enforcement action and restoration of the pharmacy’s authority to dispense controlled substances.
Just as importantly, HLA has resolved numerous DEA matters through favorable settlements that avoided protracted administrative litigation and, through early strategic advocacy, thereby protecting clients’ registrations and operations.
Anthony Mahajan and Nancy Coffey discuss DEA inspections and related board proceedings in this 37-minute recorded webinar.
Published June 4, 2024. This recording reflects the discussion at that time.
Watch on YouTube →
Health Law Alliance’s DEA defense team brings together seasoned healthcare regulatory counsel, former federal prosecution experience, and former DEA leadership. Diana Yastrovskaya represents healthcare clients in complex regulatory, civil, and criminal matters. Anthony Mahajan first prosecuted DEA criminal cases and later helped build McKesson’s Controlled Substance Monitoring Program (CSMP) as Chief Counsel for the distributor. The team works closely with former DEA Diversion Program Manager Nancy Coffey on various DEA matters, combining sophisticated legal advocacy with practical insight into DEA diversion investigations, enforcement priorities, and compliance expectations.
These circumstances help explain how an inquiry may arise. They do not establish a violation or predict its outcome.
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