FDA Ketamine Warning Letters: Criminal and Civil Exposure for Ketamine Clinics, Prescribers, and Online Sellers
FDA has put the ketamine market on notice. On June 23, 2026, FDA’s Center for Drug Evaluation and Research issued more than a dozen warning letters to websites selling unapproved and misbranded ketamine directly to U.S. consumers, including injectable vials marketed for depression and sublingual troches shipped without a prescription. The letters are one part of a larger structure. DEA registration actions, Controlled Substances Act prosecutions, and civil remedies reach clinics, compounding pharmacies, telehealth platforms, prescribers, and distributors.
Overview: Why Ketamine Is Now an Enforcement Priority
On June 23, 2026, FDA issued more than a dozen warning letters to websites selling ketamine directly to U.S. consumers, citing unapproved new drug and misbranding violations and demanding a response within 15 business days. FDA repeated a central fact in every letter: ketamine is not FDA-approved for any psychiatric disorder.
Ketamine is a Schedule III controlled substance. Distribution outside a DEA registration, or prescribing outside the usual course of professional practice, is a felony under 21 U.S.C. § 841 carrying up to 10 years per count, 15 if death or serious bodily injury results. The Matthew Perry prosecutions produced a 15-year sentence for a supplier and a 30-month sentence for a licensed physician.
DEA does not wait for an indictment. Immediate Suspension Orders stop all controlled substance activity the day they are served, and Orders to Show Cause put registrations on a 30-day clock. Civil exposure runs in parallel: FDA seizures and injunctions, CSA civil penalties, forfeiture, and False Claims Act liability for clinics that bill federal programs.
Ketamine occupies a narrow legal lane. FDA approved it decades ago as an anesthetic. Congress placed it in Schedule III in 1999. Nothing in either framework authorizes the commercial market that has grown around it: infusion clinics, telehealth platforms prescribing compounded sublingual troches, and websites shipping vials to consumers who never see a doctor. Federal enforcement is now closing on that market.
The government has now moved on all three fronts in twelve months. The Matthew Perry prosecutions in the Central District of California ended with prison sentences for a street supplier, a middleman, and two licensed physicians. DEA announced a record year of administrative actions against controlled substance registrants at the June 23, 2026 National Health Care Fraud Takedown. And on the same date, FDA’s Center for Drug Evaluation and Research issued a coordinated batch of warning letters to online ketamine sellers, posted publicly on July 7. The sweep tells wholesalers, prescribers, compounding pharmacies, and platform operators where the government is looking.
The June 23 Warning Letters: What FDA Said
The letters came from CDER’s Office of Drug Security, Integrity, and Response and its Internet Pharmacy Task Force. The recipients were websites with names that describe the business model: LyfeUnit, Ketacyn Pharmaceuticals, All Ketamine HCL, Legit Ketamine Suppliers, Buy Keta Online, Ketamine Troche Store, and ketaminetroches.com, among others. The products ranged from injectable vials marketed as mental health treatments to sublingual troches sold with no prescription requirement at all.
Each letter charges the same core violations of the Federal Food, Drug, and Cosmetic Act: sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a), codified at 21 U.S.C. §§ 331, 352(f)(1), 353(b)(1), and 355(a). Three theories do the work.
Unapproved New Drugs
A ketamine vial marketed for “Mental Health Treatments” is a drug within the meaning of 21 U.S.C. § 321(g), and a new drug under § 321(p), because it is not generally recognized as safe and effective for that use. No approved application covers it. Introducing it into interstate commerce violates §§ 331(d) and 355(a). The letters then state what is approved. FDA-approved ketamine, marketed as KETALAR, is approved only as an anesthetic administered by injection. FDA-approved esketamine, marketed as SPRAVATO, is approved for treatment-resistant depression, but only under a Risk Evaluation and Mitigation Strategy that requires administration in certified health care settings with two hours of monitoring, backed by a boxed warning for sedation, dissociation, respiratory depression, and abuse. Ketamine itself is not FDA-approved for any psychiatric disorder. Every website selling it as a depression treatment is selling an unapproved new drug.
Misbranding
A drug is misbranded under § 352(f)(1) if its labeling fails to bear adequate directions for use, meaning directions under which a layperson can use it safely. For a prescription drug intended for conditions no layperson can self-diagnose, adequate directions for lay use cannot be written. The product is misbranded by definition when sold direct to consumers. The letters add a second misbranding theory with more reach: dispensing a prescription drug without a prescription misbrands the drug under § 353(b)(1) and violates § 331(k). That theory applies to any distribution model that skips the practitioner, whether the seller is an offshore website or a domestic operation with a checkout page.
After the Warning Letter
Recipients have 15 business days to respond with corrective steps and documentation. The letters state that failure to address the violations may result in regulatory or legal action without further notice, including seizure and injunction. Two features deserve attention. First, the letters are public. DEA, state boards, payment processors, and plaintiffs’ lawyers all read them. Second, the letters create a record of notice. Under the felony provision of the FDCA, discussed below, intent to defraud or mislead converts a one-year misdemeanor into a three-year felony per count. Sales that continue after a documented FDA warning are sales made with knowledge. Prosecutors build felony intent from exactly that record.
Criminal Exposure: The FDCA and the Controlled Substances Act
FDCA Charges: Strict Liability Misdemeanors and Fraud Felonies
The conduct described in the warning letters is itself criminal. Under 21 U.S.C. § 333(a)(1), any violation of § 331 is a misdemeanor punishable by up to one year. No intent element applies. Under the responsible corporate officer doctrine of United States v. Park, 421 U.S. 658 (1975), an executive can be convicted based on a position of authority over the violation, without proof of personal knowledge. Under § 333(a)(2), a violation committed with intent to defraud or mislead is a felony carrying up to three years per count. In online drug-sale cases, the fraud evidence is usually already on the website: fabricated pharmacy credentials, claims of FDA compliance, brand names attached to product of unknown origin, and payment structures designed to evade processors. FDCA counts rarely travel alone. They arrive with wire fraud, smuggling under 18 U.S.C. § 545, and controlled substance counts.
CSA Charges: Ketamine Is Schedule III
Ketamine has been a Schedule III controlled substance since 1999. Schedule III status raises the stakes from a regulatory violation to drug trafficking. Under 21 U.S.C. § 841(a), it is unlawful to knowingly manufacture, distribute, or dispense a controlled substance except as authorized. For Schedule III substances, § 841(b)(1)(E) authorizes up to 10 years per count. If death or serious bodily injury results from use of the substance, the maximum rises to 15 years. Prior felony drug convictions double the maximums. Conspiracy under § 846 carries the same penalties as the object offense. Maintaining a premises for distribution carries up to 20 years under § 856. Importation of ketamine, the supply route behind most of the websites in the sweep, violates 21 U.S.C. §§ 952 and 960.
Prescribers: The Ruan Standard
Registered practitioners are authorized to dispense ketamine, but only within the boundary set by 21 C.F.R. § 1306.04(a): a prescription must issue for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. In Ruan v. United States, 597 U.S. 450 (2022), the Supreme Court held that once a prescriber produces evidence of authorization, the government must prove beyond a reasonable doubt that the prescriber knowingly or intentionally acted outside it. Honest clinical judgment, even bad clinical judgment, is not a crime. That standard protects practitioners who run genuine practices with documented evaluations, monitoring, and records. Volume operations without clinical substance fall outside it. Prosecutors answer Ruan with evidence that no medical practice existed: no examinations, no monitoring, cash pricing per vial, escalating quantities, sales to patients with known addiction, and messages that discuss price and quantity rather than treatment. We examined how the government charges these cases, and where the defense begins, in our analysis of healthcare fraud and illegal prescribing indictments.
The Perry Prosecutions: The Government’s Template
The prosecutions arising from Matthew Perry’s October 2023 ketamine death show how the Department of Justice applies these statutes across an entire supply chain. Five defendants were charged in the Central District of California, and all five were convicted. The supplier, Jasveen Sangha, was sentenced to 15 years in federal prison. Dr. Salvador Plasencia, a licensed physician who sold vials of ketamine to Perry outside any legitimate practice, pleaded guilty to four counts of distribution and was sentenced to 30 months, after surrendering his medical license. Dr. Mark Chavez, who operated a ketamine clinic and supplied Plasencia, pleaded guilty to conspiracy. A middleman and Perry’s assistant pleaded guilty to distribution counts.
Prosecutors wrote that the physician “sought to exploit Perry’s medical vulnerability for profit.” The court agreed and imposed prison time.
— Government sentencing memorandum, United States v. Plasencia, C.D. Cal. (sentenced December 3, 2025)The same statute reached the street supplier, the clinic operator, and the treating physician. The sentences varied with role and intent. The medical licenses did not prevent conviction, and both physicians lost them. Every participant in a ketamine transaction chain that leaves the usual course of professional practice is inside § 841.
DEA’s Role: Registration Actions Move First
Criminal charges take months or years to build. DEA’s administrative tools move in weeks. Every ketamine clinic, pharmacy, wholesaler, and prescriber operates on a DEA registration issued under 21 U.S.C. § 823, and DEA can move against that registration on a standard far below proof beyond a reasonable doubt. In the enforcement year ending with the June 2026 takedown, DEA announced a record 928 administrative actions against registrants: 53 Immediate Suspension Orders, 205 Orders to Show Cause, and 642 voluntary surrenders for cause. We analyzed those tools in detail in our analysis of DEA Immediate Suspension Orders and Orders to Show Cause. The ketamine-specific points follow.
Immediate Suspension Orders
Under 21 U.S.C. § 824(d), DEA may suspend a registration the moment the order is served, before any hearing, on a finding of imminent danger to the public health or safety. Imminent danger is a defined term: a substantial likelihood of an immediate threat of death, serious bodily harm, or abuse caused by the registrant’s failure to maintain effective controls against diversion. For a ketamine infusion clinic or a pharmacy filling telehealth troche prescriptions, an ISO ends all controlled substance activity that day. The registrant must surrender its certificate and place its stock under seal. The suspension holds through the administrative case and any judicial review. The remedy is an expedited hearing demand under 21 C.F.R. § 1301.36, and a record attack on each element of the imminent danger definition, particularly where the conduct DEA cites is stale or already corrected.
Orders to Show Cause and the 30-Day Clock
An Order to Show Cause under § 824(c) is the charging document in a registration case. The registration stays active while the case proceeds, but the registrant must request a hearing and file an answer within 30 days under 21 C.F.R. § 1301.43 and § 1301.37. Allegations not denied are deemed admitted. Miss the deadline and DEA revokes on its own record, by default. The statute also permits a corrective action plan, which can resolve or defer the proceeding. Every one of those filings is discoverable by prosecutors. A ketamine registrant answering an OTSC while a grand jury sits is drafting exhibits for two cases at once. Sequencing that answer against the criminal exposure is the central judgment in these matters.
Pharmacies: Corresponding Responsibility
The compounding pharmacies behind telehealth ketamine platforms carry their own duty. Under 21 C.F.R. § 1306.04(a), a pharmacist who fills a prescription shares responsibility for its legitimacy. A pharmacy filling thousands of sublingual ketamine prescriptions from a single telehealth platform, written after brief video encounters by a small prescriber pool across dozens of states, is filling orders that carry classic red flags. DEA has revoked pharmacy registrations on that pattern for two decades in the opioid context. The FDA warning letter batch, which included two troche-focused websites, shows the compounded ketamine channel is under the same scrutiny.
Distributors: Suspicious Order Obligations
Wholesale distributors of ketamine must register, maintain effective controls against diversion, and report suspicious orders under 21 U.S.C. § 832 and 21 C.F.R. § 1301.74(b). Orders of unusual size, pattern, or frequency from ketamine clinics and compounding pharmacies must be identified, held, and reported. The opioid litigation of the last decade established what failure looks like: registration actions, civil penalties, and in the worst cases, criminal charges against the distributor itself. A distributor whose customer appears in an FDA warning letter or a DEA order has a due diligence file that will be examined line by line.
Telemedicine: A Temporary Window
The Ryan Haight Act, 21 U.S.C. § 829(e), generally requires an in-person evaluation before controlled substances can be prescribed online. DEA and HHS have extended the COVID-era exception through a fourth temporary rule, effective through December 31, 2026, permitting audio-video telemedicine prescribing of Schedule II through V substances without a prior in-person exam. The flexibility addresses only how the encounter occurs. Section 1306.04(a) still governs every prescription. DEA’s pending special registration rulemaking would add monitoring program checks, identity verification, and platform-level registration and reporting. The flexibilities expire December 31, 2026 unless extended. FDA’s 2023 compounded ketamine alert describes the conduct the government is already policing in the meantime.
Civil Exposure: Seizure, Injunction, Penalties, Forfeiture, and the FCA
The civil track runs alongside the criminal one, and it often lands first. FDA can seize violative drugs under 21 U.S.C. § 334 and obtain injunctions under § 332 against firms and the individuals who run them. Injunction cases frequently end in consent decrees that halt operations, require independent oversight, and bind executives personally for years. The Controlled Substances Act adds civil penalties under 21 U.S.C. § 842(c) for recordkeeping, reporting, and dispensing violations, with enhanced penalties for suspicious order failures. Property that facilitates distribution, and its proceeds, is forfeitable under 21 U.S.C. § 881. Bank accounts and clinic assets can be restrained on a civil standard before any charge is filed.
Clinics and prescribers that bill federal programs face a further layer. SPRAVATO administration, evaluation and management visits, and infusion services billed to Medicare, Medicaid, or TRICARE become False Claims Act exposure under 31 U.S.C. § 3729 when the underlying services were medically unnecessary or tied to unlawful prescribing. Treble damages and per-claim penalties apply, and qui tam relators, often former employees of the clinic, initiate many of these cases. A felony controlled substance conviction also triggers mandatory exclusion from federal health care programs under 42 U.S.C. § 1320a-7(a). For a licensed professional, exclusion outlasts the sentence.
Who Carries the Exposure
The June sweep targeted websites, but the legal theories reach the entire legitimate-adjacent market. Direct-to-consumer sellers face FDCA and CSA charges together, with importation counts where product crosses the border. Ketamine infusion clinics face DEA registration actions and, where documentation is thin, criminal prescribing theories tested against Ruan. Telehealth platforms and their affiliated prescribers, whether physicians, physician assistants, or nurse practitioners, face the compounded-drug theories in FDA’s 2023 alert plus § 1306.04 scrutiny of encounter quality and volume. Compounding pharmacies face corresponding responsibility actions. Distributors face suspicious order enforcement. Executives at each level face Park doctrine misdemeanor liability even without knowledge, and felony exposure once notice exists. A warning letter, an ISO, or a payment processor termination is usually the first visible event. The investigation behind it started earlier.
Armstrong & Bradylyons PLLC: Ketamine Clinic and Controlled Substance Defense
Armstrong & Bradylyons PLLC defends medical professionals and the companies that employ them, including physicians, physician assistants, nurse practitioners, clinic owners, pharmacies, telehealth platforms, and distributors, in federal controlled substance investigations, DEA registration actions, and complex healthcare fraud cases nationwide. The firm’s ketamine clinic fraud defense practice covers FDA warning letter responses, DEA Immediate Suspension Orders and Orders to Show Cause, grand jury investigations, and trial, alongside its health care fraud defense practice.
As Director of DOJ’s Appalachian Regional Prescription Opioid Strike Force (ARPO), Scott Armstrong led the Department’s dedicated strike force for investigating and prosecuting medical professionals involved in the illegal prescribing, distribution, and diversion of controlled substances. Under ARPO, DOJ charged more than 120 defendants, including physicians, physician assistants, and nurse practitioners, collectively responsible for prescribing over 115 million controlled substance pills across 10 federal districts in six states. Scott led the prosecutors and analysts who identified targets from prescribing data and built those cases, and he tried prescription drug diversion cases as lead trial counsel. The theories the government now applies to ketamine clinics, telehealth prescribers, and pharmacies are the theories his teams built. He also served as an Assistant Chief in the Fraud Section’s Market Integrity and Major Frauds Unit and as a leading trial attorney in its Healthcare Fraud Unit, trying sixteen federal jury trials, including nine healthcare fraud trials, with lead-counsel responsibility for cases totaling over $600 million in false claims.
Drew Bradylyons served as an Assistant Chief in the Health Care Fraud Unit, where he supervised the Miami Strike Force, and as Chief of the Financial Crimes and Public Corruption Unit at the U.S. Attorney’s Office for the Eastern District of Virginia, where he supervised parallel civil, criminal, and administrative proceedings involving more than $1 billion in claims to Medicare, Medicaid, and TRICARE, including opioid diversion prosecutions of licensed professionals. He knows how a warning letter response, an OTSC answer, or a payment suspension rebuttal becomes a grand jury exhibit, because he supervised cases built that way.
The firm’s attorneys have over 25 years of combined DOJ experience and 25 federal jury trials, including 17 in healthcare fraud cases involving over $2.8 billion in alleged false claims. The firm is based in Washington, D.C. and handles matters in every federal district.
Frequently Asked Questions
Is ketamine FDA-approved for depression or other psychiatric disorders?
No. FDA-approved ketamine, marketed as KETALAR and as generics, is approved only as an anesthetic administered by intravenous or intramuscular injection. FDA stated in its June 23, 2026 warning letters that ketamine is not FDA-approved for the treatment of any psychiatric disorder. The related drug esketamine, marketed as SPRAVATO, is approved for treatment-resistant depression and for depressive symptoms with acute suicidal ideation or behavior, but only under a Risk Evaluation and Mitigation Strategy requiring administration in certified settings with two hours of post-dose monitoring, under a boxed warning for sedation, dissociation, respiratory depression, and abuse.
Physicians may prescribe FDA-approved ketamine off-label within a legitimate practitioner-patient relationship. A firm that markets ketamine for depression, anxiety, PTSD, or chronic pain is distributing an unapproved new drug under 21 U.S.C. § 355(a).
What does an FDA warning letter for unapproved and misbranded drugs mean?
It is FDA’s formal notice that the agency has documented FDCA violations and expects prompt correction. The June 2026 ketamine letters cite unapproved new drug violations under 21 U.S.C. §§ 331(d) and 355(a), misbranding under § 352(f)(1) for failure to bear adequate directions for use, and dispensing prescription drugs without a prescription under §§ 353(b)(1) and 331(k). Recipients have 15 business days to respond in writing with corrective steps and documentation.
A warning letter is not final agency action, but it is rarely the end. The letters state that failure to address the violations may result in regulatory or legal action without further notice, including seizure and injunction. The letters are public, DEA and state boards read them, and they create a record of notice that prosecutors use to prove felony intent under 21 U.S.C. § 333(a)(2). Sales that continue after a warning letter are sales made with documented knowledge.
What criminal penalties apply under the FDCA for selling misbranded or unapproved drugs?
Both misdemeanor and felony penalties under 21 U.S.C. § 333. A first violation of § 331 is a misdemeanor punishable by up to one year, with no intent requirement. Under the responsible corporate officer doctrine of United States v. Park, 421 U.S. 658 (1975), an executive can be convicted based on authority over the violation, without personal knowledge. The felony provision, § 333(a)(2), applies when the violation is committed with intent to defraud or mislead, or after a prior conviction, and carries up to three years per count.
Fraudulent intent is typically proven through website claims, fake credentials, evasion of payment processors, and continued sales after FDA notice. FDCA counts frequently travel with wire fraud, smuggling, and Controlled Substances Act charges, which carry substantially higher maximums.
Can compounded ketamine troches be legally dispensed?
Only within narrow limits, and never without a valid prescription. Compounded drugs, including sublingual ketamine troches, are not FDA-approved. Pharmacies compounding under section 503A of the FDCA must compound pursuant to a valid patient-specific prescription; outsourcing facilities under section 503B operate under separate conditions. FDA’s October 2023 alert warned about compounded ketamine, including oral formulations marketed for psychiatric disorders through telemedicine platforms, citing risks of abuse, misuse, and respiratory depression without on-site monitoring.
Two of the websites in the June 2026 sweep sold ketamine troches directly to consumers with no prescription. That model fails every condition. It misbrands the drug under 21 U.S.C. § 353(b)(1), and because ketamine is Schedule III, unregistered distribution also violates § 841. Pharmacies filling high volumes of telehealth ketamine prescriptions carry corresponding responsibility under 21 C.F.R. § 1306.04(a).
Is it legal to buy ketamine online in the United States?
No, except through a valid prescription dispensed by a state-licensed, DEA-registered pharmacy. Ketamine is a prescription drug and a Schedule III controlled substance. A website that ships ketamine to a consumer without a prescription is dispensing a misbranded drug under 21 U.S.C. § 353(b)(1), and where the product is marketed for depression or other unapproved uses, an unapproved new drug under § 355(a). Because ketamine is scheduled, distribution outside a DEA registration also violates 21 U.S.C. § 841, and foreign shipments implicate the importation provisions of §§ 952 and 960.
FDA’s June 2026 warning letters describe the consumer risks directly: products sold outside regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredient, or contain different ingredients altogether, and injectable products bypass the body’s natural defenses and can cause septicemia or sepsis. The websites named in the sweep sold both injectable vials and sublingual troches with no prescription requirement.
Is ketamine a controlled substance, and what are the penalties for illegal distribution?
Yes. Ketamine has been a Schedule III controlled substance since 1999. Manufacturing, distributing, or dispensing it outside a DEA registration, or prescribing it outside the usual course of professional practice, violates 21 U.S.C. § 841(a). For Schedule III substances, § 841(b)(1)(E) authorizes up to 10 years per count, rising to 15 years if death or serious bodily injury results, with doubled maximums after a prior felony drug conviction. Conspiracy under § 846 carries the same penalties. Maintaining a distribution premises carries up to 20 years under § 856, and importation violates §§ 952 and 960.
The Matthew Perry prosecutions show the range: the supplier received 15 years, and a licensed physician received 30 months on four distribution counts.
How can DEA suspend or revoke a ketamine clinic’s or pharmacy’s registration?
Through an Order to Show Cause or an Immediate Suspension Order under 21 U.S.C. § 824. An OTSC states the grounds for revocation and triggers a hearing right before a DEA administrative law judge, but the registrant must request the hearing and answer within 30 days under 21 C.F.R. §§ 1301.43 and 1301.37, or the allegations are deemed admitted and the registration can fall by default. An ISO under § 824(d) suspends the registration the moment it is served, before any hearing, on a finding of imminent danger. All controlled substance activity stops that day.
DEA announced a record 928 administrative actions in the enforcement year ending with the June 2026 takedown, including 53 ISOs and 205 OTSCs. These proceedings are independent of criminal prosecution, and every statement made in them is available to prosecutors. Our analysis of DEA Immediate Suspension Orders and Orders to Show Cause covers the hearing rules, corrective action plans, and defense sequencing in detail.
Can physicians prescribe ketamine through telemedicine in 2026?
Yes, within limits that are temporary. The Ryan Haight Act, 21 U.S.C. § 829(e), generally requires an in-person evaluation before online prescribing of controlled substances. DEA and HHS extended the COVID-era exception through a fourth temporary rule, effective through December 31, 2026, permitting audio-video telemedicine prescribing of Schedule II through V substances without a prior in-person exam, if the prescription otherwise complies with federal and state law.
The flexibility does not change the substantive standard. Every prescription must issue for a legitimate medical purpose in the usual course of professional practice under 21 C.F.R. § 1306.04(a). DEA’s pending special registration rulemaking would add monitoring program checks, identity verification, and platform registration and reporting. Volume-driven telehealth ketamine models sit at the center of the risk FDA flagged in its 2023 compounded ketamine alert.
What intent must the government prove to convict a ketamine prescriber?
The government must prove beyond a reasonable doubt that the prescriber knowingly or intentionally acted without authorization. In Ruan v. United States, 597 U.S. 450 (2022), the Supreme Court held that the knowing-or-intentional mens rea in 21 U.S.C. § 841 applies to the authorization exception for registered practitioners. Once the prescriber produces evidence of authorization, the government bears the burden of proving the prescriber knew or intended that the prescriptions fell outside the usual course of professional practice or lacked a legitimate medical purpose. Honest clinical judgment, even mistaken judgment, does not satisfy the standard.
Prosecutors answer with evidence that no genuine practice existed: no examinations, no monitoring, cash pricing per vial, escalating quantities, and sales to patients with known addiction. Contemporaneous clinical documentation is the core defense evidence. Ruan governs criminal cases only; DEA can revoke a registration under § 824 on conduct that would not support a conviction.
Can nurse practitioners and physician assistants be charged in ketamine prescribing cases?
Yes. Any DEA-registered practitioner authorized to prescribe under state law, including nurse practitioners and physician assistants, is subject to 21 U.S.C. § 841 and the legitimate medical purpose standard of 21 C.F.R. § 1306.04(a), and to registration actions under § 824. Telehealth ketamine platforms often rely on small pools of NP and PA prescribers writing across dozens of states after brief video encounters. That structure concentrates prescribing volume in a few registrations, and prescribing data analytics flag exactly that pattern. Supervising physicians, medical directors, and clinic owners face conspiracy and aiding-and-abetting exposure under 21 U.S.C. § 846 and 18 U.S.C. § 2, and companies can be charged alongside the individuals.
The Ruan intent standard protects all practitioner types equally, and the defense evidence is the same: contemporaneous evaluations, monitoring, and records showing genuine clinical judgment. DOJ’s ARPO Strike Force, which Scott Armstrong directed, charged prescribers across all three license types. The firm now defends that same population.
What civil liability do ketamine sellers, clinics, and distributors face?
Several layers. FDA can seize violative drugs under 21 U.S.C. § 334 and obtain injunctions under § 332 against firms and individuals, often through consent decrees that halt operations and impose long-term oversight. The CSA authorizes civil penalties under 21 U.S.C. § 842(c) for recordkeeping, reporting, and dispensing violations, with enhanced penalties for suspicious order failures under § 832. Facilitating property and proceeds are forfeitable under § 881.
Clinics and prescribers that bill Medicare, Medicaid, or TRICARE, including for SPRAVATO, evaluation and management visits, or infusion services, face False Claims Act exposure under 31 U.S.C. § 3729, with treble damages and per-claim penalties, when claims rest on medically unnecessary services or unlawful prescribing. A felony controlled substance conviction triggers mandatory program exclusion under 42 U.S.C. § 1320a-7(a), and state boards act on federal findings in parallel.
Where does Armstrong & Bradylyons PLLC defend ketamine and controlled substance investigations?
Armstrong & Bradylyons PLLC defends medical professionals and the companies that employ them, including physicians, physician assistants, nurse practitioners, clinic owners, pharmacies, telehealth platforms, and distributors, in federal controlled substance investigations and complex healthcare cases nationwide, through its ketamine clinic fraud defense practice and its controlled substances diversion defense practice.
As Director of DOJ’s Appalachian Regional Prescription Opioid Strike Force, Scott Armstrong led the Department’s dedicated strike force for prosecuting medical professionals involved in illegal prescribing, distribution, and diversion of controlled substances. ARPO charged more than 120 defendants, including physicians, physician assistants, and nurse practitioners, collectively responsible for prescribing over 115 million controlled substance pills across 10 federal districts in six states, and Scott tried prescription drug diversion cases as lead trial counsel. He also served as a leading trial attorney in DOJ Fraud Section’s Healthcare Fraud Unit and as an Assistant Chief in its Market Integrity and Major Frauds Unit, trying sixteen federal jury trials. Drew Bradylyons served as an Assistant Chief in the Health Care Fraud Unit, where he supervised the Miami Strike Force, and as Chief of the Financial Crimes and Public Corruption Unit at the U.S. Attorney’s Office for the Eastern District of Virginia, where he supervised parallel civil, criminal, and administrative proceedings involving more than $1 billion in claims, including opioid diversion prosecutions of licensed professionals.
The firm’s attorneys have over 25 years of combined DOJ experience and 25 federal jury trials, including 17 in healthcare fraud cases involving over $2.8 billion in alleged false claims. The firm is based in Washington, D.C. and handles matters in every federal district.
