Is Ketamine Legal? Understanding the Legal Status of Ketamine Therapy

Ketamine Therapy Basics

Is Ketamine Legal? Understanding the Legal Status of Ketamine Therapy

Written by

Isha Team

published:

April 24, 2022

updated:

October 27, 2023

Ketamine is a medication that has been used for decades in the United States for various medical purposes, including as an anesthetic during surgical procedures. In recent years, there has been an increase in its use for the management of mental health disorders, such as depression, anxiety, PTSD, and chronic pain. As a result, patients often ask about the legal status of ketamine and its potential impact on their treatment.

Ketamine is legal when prescribed by licensed medical professionals in the United States. It has been in use for a variety of medical reasons since its invention in the 1960s. The more we study ketamine, the better doctors can tailor its use for their patients’ health.

In just the past few years, there have been many clinical trials studying ketamine’s role as an antidepressant and as a non-opiate medication for the management of chronic pain. In light of these findings, doctors have begun prescribing ketamine assisted therapy as a treatment for depression, anxiety, PTSD, and chronic pain.

Legal Uses of Ketamine

Ketamine is legal in the US when prescribed by licensed medical professionals. The drug has been extensively researched and found to be safe and effective in several medical contexts. The FDA approved ketamine as an anesthetic in 1970, and it is commonly used today by doctors and veterinarians for procedural sedation.

In addition, ketamine has been shown to be useful for treating depression and anxiety at much lower doses than those used for procedural sedation. These lower doses allow patients to experience some of the mind-altering effects of the drug, which can lead to new neuronal connections and improve mood while decreasing the depth and frequency of depressive episodes.


FDA and DEA Scheduling of Ketamine

The current schedule status of ketamine with the DEA is schedule lll, meaning it has a low to moderate potential for physical and psychological dependence. However, the drug is only legal when prescribed by a licensed medical practitioner. The FDA has approved ketamine for use in medical contexts and also approved esketamine, a derivative of ketamine, for treating depression in adults.(Read more about the difference between Racemic Ketamine vs. R-Ketamine vs. S-Ketamine)


Off-Label Ketamine

Off-label is a term in medicine that means the medication is used to treat conditions outside of its original intent. In this case, ketamine was initially approved by the FDA for use as an anesthetic during surgical procedures. However, further research on the drug has indicated its effectiveness in treating other conditions such as depression, anxiety, chronic pain, and PTSD. When ketamine is prescribed by a doctor to treat one of those, or another, conditions, it is referred to as ‘off-label use of ketamine.


Off-label ketamine is legal everywhere in the United States. Many people misinterpret the phrase off-label as meaning shady or less than legal, but that is not the case. The reason that the phrase off-label exists is that when a medicine is approved by the FDA, that approval refers to one specific purpose. approval doesn’t refer to legality, but it does demonstrate that the drug has been thoroughly researched and proven to be effective for that indication. Other indications have not yet been fully evaluated by the FDA. Many commonly prescribed medications are used in their “off-label” indications, and many eventually get full FDA approval.


Recently, the FDA approved intranasal esketamine, a form of ketamine, for treating depression [3]. However, medical professionals can legally prescribe ketamine for anxiety, depression, and PTSD, as an off-label indication. Obtaining FDA approval typically involves a manufacturer of medication conducting a large study that costs quite a bit of money. These are done when the manufacturer thinks that they will make money on the drug, but often cheaper medications are continued to be used Off-label because there is no financial incentive to obtain the label indication for the drug.


Take the first step to start feeling better: Ketamine for depression


When Is Ketamine Illegal?

Any use of ketamine outside of a licensed medical professional’s prescription is considered illegal. In the US, it is known as special K, baby food, kit kat, vitamin k, or K hole when sold on the streets for recreational use [4]. Recreational ketamine is often a much more high dose than the ketamine prescribed by doctors. Street ketamine is frequently used because of its euphoric properties, but prescription ketamine is prescribed at a much lower dosage.

In an unsupervised setting, ketamine can cause mild to serious adverse side effects like nausea, unpleasant dissociation, or dizziness. Additionally, street ketamine is often cut or mixed with other drugs which may increase the risk of serious negative side effects.

ISHA’s Commitment to You

When you’re in the care of ISHA’s medical professionals, we take your safety seriously.  Our practitioners are board-certified and will only prescribe you treatments that are scientifically backed and fully legal in the United States. You can have the benefits of ketamine therapy from the comfort of your own home. We are here to ensure that you have the best experience possible and to answer any questions you might have during the experience.

Contact us today at info@isha.health for more information about ketamine-assisted therapy and whether it is right for you.


References:

  • American Psychiatric Association. (2017). Practice guideline for the treatment of patients with major depressive disorder. Retrieved from https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf
  • Niciu, M. J., & Zarate Jr, C. A. (2015). Ketamine: A potential rapid-acting antidepressant. Expert Opinion on Investigational Drugs, 24(2), 169-181. doi: 10.1517/13543784.2015.989731
  • Newport, D. J., Carpenter, L. L., McDonald, W. M., Potash, J. B., Tohen, M., Nemeroff, C. B., & APA Council of Research Task Force on Novel Biomarkers and Treatments. (2015). Ketamine and other NMDA antagonists: Early clinical trials and possible mechanisms in depression. The American Journal of Psychiatry, 172(10), 950-966. doi: 10.1176/appi.ajp.2015.15040465
  • Rodriguez, C. I., Kegeles, L. S., Levinson, A., Feng, T., Marcus, S. M., Vermes, D., … & Lapidus, K. A. (2019). Randomized controlled crossover trial of ketamine in obsessive-compulsive disorder: Proof-of-concept. Neuropsychopharmacology, 44(6), 1222-1229. doi: 10.1038/s41386-019-0333-7
  • Sinner, B., & Graf, B. M. (2008). Ketamine. Handbook of Experimental Pharmacology, 182, 313-333. doi: 10.1007/978-3-540-74806-9_14
  • US Drug Enforcement Administration. (n.d.). Drug scheduling. Retrieved from https://www.dea.gov/drug-scheduling
  • US Food and Drug Administration. (2019). FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified-doctors
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