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Does the DEA Investigate Medical Providers that Prescribe and Administer Ketamine?

The Investigation Has Already Commenced

The agency investigates ketamine providers with the same instruments, the same statutory authority, and the same institutional resolve it has directed at opioid prescribers for the preceding two decades. That sentence should not require an article to support it, and yet every month this firm receives calls from physicians who believed their ketamine practice occupied a regulatory space the DEA had not yet chosen to enter. The space was never unoccupied. The agency was present before the clinic opened its doors, embedded in the ARCOS transaction reports that recorded the first order of ketamine from the distributor, in the Prescription Drug Monitoring Program entries that documented the first prescription, in the data infrastructure that assembled itself around the practice without announcement or ceremony.

The question is not whether the DEA investigates ketamine providers. The question is what triggers the investigation, what the investigation examines, and whether the provider’s documentation can sustain the weight the agency will place upon it.

What Produces the Agency’s Attention

In eight of the last eleven ketamine matters this firm has reviewed, the initiating event was not an algorithmic flag from the ARCOS database or a PDMP anomaly report. It was a human being. A former employee who departed on terms that left something unresolved. A pharmacist who received a prescription for compounded ketamine lozenges in a quantity that exceeded what the pharmacist’s professional judgment could reconcile with individualized patient care. A patient’s spouse who discovered a charge on an insurance statement for a service the patient could not explain. The agency’s analytical instruments are formidable, but the most common origin of a ketamine investigation in 2026 remains the complaint, filed through the DEA’s Diversion Tip Line or communicated to a state medical board that forwards the information to the agency’s field division office.

The algorithmic triggers do exist. ARCOS receives transaction reports from manufacturers and distributors for Schedule III controlled substances, and the agency’s ARCOS IQ analytical platform constructs a purchasing profile for every registered entity that orders ketamine. When a clinic’s ketamine orders deviate from the median purchasing pattern of comparable registrants in its geographic area, the deviation produces a data point the field division can elect to investigate. The threshold at which a deviation becomes actionable is not published. It is not codified. It resides within the discretion of the Diversion Control Division’s analytical staff, and the practitioner whose ordering volume has triggered the algorithm will not receive notification that the comparison has occurred.

The agency does not announce its interest. It cultivates it. By the time a Diversion Investigator presents DEA Form 82 at the front desk of a ketamine clinic, the agency has assembled a documentary record the provider has never seen and cannot access.

State Prescription Drug Monitoring Programs furnish the second data stream. Every ketamine prescription dispensed through a retail or compounding pharmacy enters the state PDMP, and forty-seven states now participate in interstate data sharing agreements that permit the agency to observe prescribing patterns across jurisdictions. A provider who prescribes ketamine to patients in multiple states generates PDMP entries in each of those states, and the aggregated data reveals a prescribing volume and geographic distribution the provider may not have recognized as anomalous from the vantage of individual clinical encounters.

The Diversion Investigator at the Door

In the spring of 2024, the DEA’s Diversion Control Division employed approximately 575 Diversion Investigators nationwide. These are the individuals who conduct inspections of registered facilities, and they arrive bearing credentials that authorize them to examine every controlled substance record the registrant maintains. The inspection begins with the presentation of DEA Form 82, the Notice of Inspection of Controlled Premises, and the scope of what follows depends on whether the visit constitutes a routine cyclical inspection or an investigation prompted by a complaint, a data anomaly, or a referral from another agency.

The distinction matters, though not in the manner most providers assume.

A routine inspection examines storage conditions, record-keeping practices, inventory reconciliation, and the security measures the registrant has implemented to prevent unauthorized access to controlled substances. The investigator will request dispensing logs, patient administration records, purchasing invoices, and the biennial inventory the registrant is required to conduct under 21 C.F.R. 1304.11. The investigator will count the ketamine on the premises. The investigator will compare that count to the arithmetic the records produce: ketamine ordered minus ketamine administered or dispensed should equal ketamine remaining. A discrepancy of six vials between the documentary record and the physical count is not a discrepancy the investigator will attribute to evaporation.

A targeted investigation, initiated by complaint or data referral, examines the same records with a different institutional posture. The investigator may request patient files. The investigator may interview staff members, and those interviews, which appear conversational, generate statements the agency retains and may introduce in subsequent proceedings. The investigator may request financial records that illuminate the relationship between patient volume, revenue, and prescribing patterns. I have observed targeted inspections that concluded in an afternoon and targeted inspections that extended across months of document production, and the variable that determined the duration was not the complexity of the practice but the condition of its records.

The Cases That Redefined the Enforcement Perimeter

In January 2024, a federal grand jury in the Eastern District of Missouri returned a twenty-two count indictment against two physicians in connection with a ketamine infusion clinic in south St. Louis County. The central allegation concerned the use of one physician’s DEA registration by another physician at a location the registration did not authorize, while the registrant maintained only telephonic contact with the facility. The indictment included charges of conspiracy to distribute a controlled substance, maintaining a drug-involved premises, and false statements related to healthcare matters. The case instructed the enforcement community that registration violations, which many practitioners regard as administrative technicalities, constitute the predicate offenses upon which the agency constructs its prosecutions.

In August 2024, the Central District of California charged five individuals in connection with the ketamine overdose death of Matthew Perry. Two physicians were among the defendants. Dr. Salvador Plasencia pleaded guilty to four counts of ketamine distribution and received thirty months in federal prison. Dr. Mark Chavez pleaded guilty to conspiracy and received eight months of home confinement. Jasveen Sangha, identified in court documents as the source of the ketamine that caused Perry’s death, pleaded guilty to distribution charges including distribution resulting in death. The case produced something the agency’s compliance bulletins and regulatory guidance had never accomplished: national attention to the consequences of ketamine prescribing that operates outside the boundaries the Controlled Substances Act delineates.

DEA Administrator Anne Milgram compared the ketamine market to the early stages of the opioid crisis. That comparison, delivered by the agency’s most senior official in the context of a prosecution that consumed the national press for weeks, was not rhetorical.

The Compounding Corridor and Its Particular Exposure

In October 2023, the FDA published a safety alert identifying risks associated with compounded ketamine products for psychiatric disorders, including sublingual lozenges, oral solutions, and nasal sprays administered outside clinical settings. In February 2022, the agency had issued a separate alert concerning compounded ketamine nasal spray. The alerts did not prohibit compounding. They did not restrict prescribing. They established, in the public record, that the federal government regards unsupervised self-administration of compounded ketamine as a source of patient harm, and the practitioner who prescribes compounded ketamine for home use after these alerts were published cannot claim ignorance of the risk the government has identified.

The compounding pharmacy that formulates ketamine under Section 503A of the Federal Food, Drug, and Cosmetic Act must hold a DEA registration if it compounds controlled substances. The 503B outsourcing facility must register with both the DEA and the FDA. Both categories of pharmacy generate records the agency can inspect, and the correspondence between the practitioner’s prescribing volume and the pharmacy’s compounding volume constitutes an arithmetic the agency examines with the same precision it applies to any controlled substance transaction. When a practitioner prescribes 4,000 units of compounded ketamine in a calendar quarter and the compounding pharmacy’s records indicate it filled 4,000 prescriptions bearing that practitioner’s DEA number, the agency possesses a data point that invites further examination of whether 4,000 individualized clinical assessments could plausibly have occurred within the timeframe the records describe.

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Once the compounded lozenge or nasal spray departs the pharmacy, the chain of custody fractures. The prescriber cannot verify administration. The prescriber cannot prevent diversion. The prescriber cannot monitor for the dissociative effects the FDA’s own alerts have identified as a source of concern. That fracture is the space in which the agency’s investigative interest concentrates, because the closed system the Controlled Substances Act established depends upon accountability at every point in the distribution chain, and a compounded ketamine lozenge in a patient’s medicine cabinet is a point at which accountability becomes a function of trust rather than documentation.

The Telehealth Model Under Provisional Authority

The Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities, published December 31, 2025, preserves the conditions under which most telehealth ketamine prescribing operates through December 31, 2026. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 prohibits the prescribing of controlled substances without a prior in-person medical evaluation, and the pandemic-era flexibilities suspended that prohibition on a temporary basis. The suspension has been renewed four times. The proposed Special Registration for Telemedicine, which would establish permanent conditions for remote controlled substance prescribing, has not advanced to final rulemaking.

A telehealth ketamine provider who evaluates patients by video, prescribes compounded ketamine to be shipped to the patient’s residence, and maintains no physical location where the substance is administered occupies a position the existing regulatory framework was not designed to contain. The provider holds a DEA registration at an address. The patient receives the substance at a different address. The clinical encounter occurs at neither address. The Ryan Haight Act contemplated a prescriber and a patient in the same room, and the temporary flexibilities permit a deviation from that contemplation without resolving the enforcement questions the deviation produces.

The agency has been patient with telehealth ketamine. The patience of a regulatory agency is not forbearance. It is the accumulation of a record the agency will examine when the patience concludes.

In May 2023, the DEA suspended the controlled substance registration of a South Carolina telehealth prescriber whose ketamine prescribing volume the agency characterized as incompatible with individualized clinical assessment. The suspension was not accompanied by criminal charges. It did not require a criminal proceeding. It required only the agency’s determination that an imminent danger to public health or safety existed, a determination the agency makes unilaterally and that the registrant may contest only after the registration has already been suspended. The practitioner who regards the telehealth flexibilities as a shield against enforcement scrutiny has confused the permission to prescribe with protection from the consequences of prescribing without adequate documentation.

The Concurrent Machinery of Federal and State Inquiry

In March of 2026, the investigative apparatus that confronts a ketamine provider operates on multiple planes simultaneously. The DEA’s Diversion Control Division conducts inspections and initiates administrative proceedings. The Department of Justice files criminal indictments when the evidence supports charges of unlawful distribution. The Department of Health and Human Services Office of Inspector General investigates claims submitted to Medicare and Medicaid for ketamine infusion services. The state medical board investigates complaints concerning the standard of care. Medicare Administrative Contractors and Unified Program Integrity Contractors conduct billing audits of ketamine-related claims. These agencies share information. A board investigation produces records that federal prosecutors subpoena. A billing audit reveals prescribing patterns the DEA examines. A DEA inspection generates findings the medical board incorporates into its own proceedings.

The provider who receives an inquiry from one agency should proceed on the assumption that the inquiry has implications that extend beyond the agency that initiated it. That assumption, in my experience, has never proven unwarranted.

Todd Spodek
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The Documentation That Determines the Outcome

Every investigation this firm has defended in the ketamine space has reduced, in its final analysis, to a question of records. The agency does not possess the expertise to evaluate whether a particular ketamine protocol constitutes sound clinical practice. It possesses the authority to evaluate whether the practitioner documented a clinical rationale for each patient, consulted the PDMP before prescribing, conducted an intake assessment that reflects individualized judgment rather than a protocol applied without variation, maintained informed consent records that identify the off-label nature of the use and the absence of FDA approval for the psychiatric indication, and reconciled its controlled substance inventory with the precision the regulations demand.

The provider whose records demonstrate these elements occupies a position the enforcement apparatus was not designed to threaten.

The provider whose records do not demonstrate them occupies a position in which the clinical merit of the treatment, the sincerity of the therapeutic intention, the gratitude of the patients who received relief from conditions that had not responded to conventional pharmacotherapy, none of this will appear in the agency’s assessment. The file will contain the records. The records will contain what the records contain. The agency will read them the way the agency reads every file: as a question of whether the registrant complied with the obligations the registration imposed, and whether the substance traveled from the distributor to the patient through a chain the documentation can account for without interruption.

What the Enforcement Trajectory Portends

In 2015, fewer than one hundred ketamine clinics operated in the United States. By 2024, the number exceeded fifteen hundred. The National Forensic Laboratory Information System reported 3,557 forensic laboratory exhibits involving ketamine in 2024, an increase from 1,965 in 2021. Pharmaceutical diversion reports rose to 286 in 2024 from 183 in 2021. The agency interprets these figures as a trend, and the enforcement posture follows the data with a fidelity that should concern every provider who has treated the present regulatory environment as the permanent one.

The DEA investigated medical providers who prescribed and administered opioids for years before the enforcement campaign reached its full institutional velocity. The investigation of ketamine providers has commenced along a trajectory that resembles the earlier campaign in its structure, if not yet in its scale. The agency identifies the substance. It assembles the data. It prosecutes the cases that produce the most instructive outcomes. It publicizes those cases through press releases and sentencing announcements calibrated to alter the behavior of the providers who read them. The Matthew Perry prosecution was not an isolated enforcement event. It was the agency’s declaration that ketamine occupies the same position in its institutional priorities that oxycodone occupied in 2010, though the qualifications one might attach to that comparison tend to dissolve upon examination of the indictments that have followed.

The provider who contacts counsel before the agency’s interest becomes the agency’s action establishes the conditions under which a defense, if one becomes necessary, can be conducted from a position of documented compliance rather than retrospective reconstruction. A consultation is where that assessment begins.

The Controlled Substances Act does not distinguish between substances the public regards as therapeutic and substances the public regards as dangerous. It distinguishes between registrants whose records account for the substance and registrants whose records do not. The agency that enforces the Act observes the same distinction, with a patience that belongs to institutions rather than to the individuals whose conduct those institutions will, in a season of their own selection, evaluate.

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ABOUT THE AUTHOR

Todd Spodek

Managing Partner

With decades of experience in high-stakes federal criminal defense, Todd Spodek has built a reputation for aggressive, strategic representation. Featured on Netflix's "Inventing Anna," he has successfully defended clients facing federal charges, white-collar allegations, and complex criminal cases in federal courts nationwide.

Bar Admissions: New York State Bar New Jersey State Bar U.S. District Court, SDNY U.S. District Court, EDNY
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