Doctors, Pharmacies, and Practitioners Can Face Substantial Civil or Criminal Penalties for Illegally Prescribing Ketamine
The use of ketamine to treat severe depression and other mental health conditions has drawn substantial interest in the medical community. However, while studies have shown that ketamine treatment can produce positive results for some patients, the risks of using ketamine are well established as well.
Due to the risks of ketamine, it is a Schedule III controlled substance. This means that doctors, pharmacies, and practitioners must strictly adhere to the rules and requirements that apply to all controlled substances when prescribing, dispensing, or administering ketamine. Failure to do so can have serious consequences, with civil and criminal penalties being available under the Controlled Substances Act (CSA).
The Penalties for Unlawfully Prescribing Ketamine
The penalties for unlawfully prescribing ketamine depend on several factors. In the healthcare setting, the two primary considerations are (i) whether the violation at issue is deemed civil or criminal, and (ii) how often the violation occurred.
1. Civil Penalties for Unlawfully Prescribing Ketamine
Under the CSA, each violation is subject to a maximum civil penalty of $65,440. So, if a doctor illegally prescribes ketamine to one patient on 12 separate occasions, the doctor could face up to $785,280 in civil penalties (12 violations x $65,440). However, if a doctor illegally prescribes ketamine to 12 patients on 12 separate occasions, the doctor could face up to $9,423,360 in civil penalties (144 violations x $65,440).
Along with civil monetary penalties, doctors can also face other penalties for unlawfully prescribing ketamine as well. For example, if a doctor repeatedly prescribes ketamine in violation of the CSA or deadiversion.usdoj.gov/21cfr/21usc/index.html">DEA regulations (either intentionally or unintentionally), the DEA can pursue emergency suspension or revocation of the doctor’s DEA registration. As a result, not only can violations of the CSA be extremely expensive, but they can essentially force doctors to shut down their practices as well.
2. Criminal Penalties for Unlawfully Prescribing Ketamine
Under the CSA, criminal violations are subject to fines of up to $100,000 and up to one year in federal prison. These penalties apply to each separate violation. For doctors, the criminal provisions of the CSA apply in cases involving “knowingly or intentionally” distributing ketamine “except as authorized” under the Act. This means that doctors who prescribe ketamine with knowledge that they are violating the CSA can face criminal prosecution.
In addition to civil and criminal violations of the CSA, unlawful prescription of ketamine can lead to other federal charges as well. The U.S. Department of Justice (DOJ) frequently prosecutes cases of alleged controlled substance prescription fraud alongside charges for healthcare fraud, tax fraud, insurance fraud, and money laundering. As a result, facing charges for unlawfully prescribing ketamine has the potential to lead to life-altering consequences.
What Constitutes “Unlawful” Ketamine Prescription?
Due to the substantial civil and criminal penalties that are at stake, when facing scrutiny from the DEA, DOJ, or another federal agency, doctors and other healthcare providers must be able to defend their ketamine prescription practices by all means available. One option is to argue that what the government is characterizing as “unlawful” is, in fact, a lawful exercise of the provider’s discretion to prescribe a Schedule III controlled substance under the CSA.
For example, while 21 U.S.C. Section 841 prohibits dispensing controlled substances “except as authorized” by the CSA, the CSA authorizes the dispensing of controlled substances for legitimate medical purposes. This includes dispensing controlled substances for “maintenance or detoxification treatment.” As a result, healthcare providers can defend against prosecution by showing that their ketamine prescriptions were not necessarily unlawful.
Another potential defense is to challenge the sufficiency of the government’s evidence. Under the CSA, both civil and criminal violations require evidence that the healthcare provider prescribed or dispensed ketamine in violation of the Act. Establishing these violations requires evidence of the provider’s actions as well as the provider’s knowledge and intent.
In many cases, the government’s case will not be as strong as prosecutors believe. This is particularly true in cases involving allegations of unlawful ketamine prescription, as issues of legitimate medical practice, knowledge, and intent are all open to debate. Considering the substantial civil or criminal penalties that are at stake, healthcare providers targeted for alleged unlawful ketamine prescription need to work with an experienced defense team that can assess the government’s case and present all available defenses on their behalf.
Learn More About Defending Against Allegations of Unlawful Ketamine Prescription
At Spodek Law Group, we are actively representing healthcare providers in cases involving allegations of unlawful ketamine prescription. We anticipate that these cases will become more common as ketamine continues to gain acceptance as an alternative to traditional antidepressants, and it is critical for healthcare providers to keep in mind that the DEA and other federal agencies are actively monitoring providers’ ketamine-prescribing practices. If you have questions about defending against allegations of unlawful ketamine prescription, we encourage you to contact us promptly for more information.
Contact Spodek Law Group
If you are facing allegations related to unlawful ketamine prescription, our legal team can help. Call us at 212-300-5196 or contact us online to schedule a confidential consultation.
