Ketamine's Legal Status: Everything You Need to Know

Medically reviewed by 
Leonardo Vando, MD
Published on 
October 16, 2020
Updated on 
July 27, 2022

"Is Ketamine legal?" is a common, and legitimate question from those looking to explore psychedelic medicine for therapeutic treatment of their depression and anxiety.

Ketamine is legal for use by registered practitioners, and historically has a high safety profile in surgical and therapeutic use since its synthesis in the 1960’s. Its scope of treatment and potential use-cases continue to grow and develop as ketamine is studied further

More and more we are seeing promising areas that ketamine is uniquely suited to help with, in everything from surgical procedures to relieving treatment-resistant depression and anxiety symptoms.

Is ketamine legal?

Ketamine is legal for medical use in the United States and select countries across the world. 

The use of ketamine is regulated, meaning it can only be administered or prescribed by licensed clinicians with the authority and expertise to support its effective use.

When used within the context of a surgical procedure or as prescribed by a licensed clinician, it is legal to administer. Any other use of this medicine outside of these guidelines, such as recreationally, is illegal and currently unregulated.

Ketamine’s FDA and DEA scheduling

Ketamine is an FDA-approved anesthetic, and is available for “off-label” prescription by a licensed clinician. “Off-label” prescription is when a medicine is used to treat another condition outside of its original medicinal intent. More on this below.

Ketamine has been approved by the Food and Drug Administration (FDA) for medical use as an anesthetic since 1970. In addition to off-label ketamine prescriptions, the FDA recently approved derivatives such as esketamine for treatment of adults with treatment-resistant depression.

Ketamine is currently listed as a Schedule III compound under DEA guidelines. 

This means it is generally accepted to have medical value for specific purposes, and must be administered by a licensed provider to be distributed effectively.

The Drug Enforcement Administration (DEA) schedules controlled substances or compounds 1 through 5. Any compound receiving a 2, 3, 4, or 5 rating is designated as having viable medical uses, and is legal to administer so long as it is through a licensed provider to treat a specific condition.

Is “off-label” ketamine treatment legal as well?

Ketamine is able to be prescribed “off-label”, which can, understandably, be a confusing term. A common misconception about “off-label” prescribing is that it’s potentially illegal or otherwise untrustworthy. 

Generally, when a drug or compound is approved for medical use, it is approved to treat a very specific ailment or serve a very particular purpose. Originally, ketamine was approved for use as a general anesthetic in surgeries that do not require skeletal muscle relaxation. This is the labelled use.

If the compound or medicine is prescribed and used to treat something other than the original designation, this is considered off-label use. This is a relatively common practice, with studies showing that one in five prescriptions are given off-label. Fully labeling a medicine for FDA-approved use is a time and cost-prohibitive process, and is typically sought out by pharmaceutical companies looking to apply the medicine for a specific consumer use case.

Fortunately, new science and research is emerging showing that ketamine can be highly effective in treating treatment-resistant depression, anxiety, PTSD, OCD, chronic pain, and a growing list of other applications.

If prescribed for any of these use-cases, this is considered off-label use, and it is completely legal — so long as it is prescribed by a licensed practitioner for this particular use.

What are the legal applications of ketamine?

Ketamine for general anesthesia

Ketamine was originally synthesized for use as a general anesthetic in medical and surgical procedures. 

To this day it continues to be used in emergency rooms and in surgeries across the country to help manage pain and induce sedation. Due to its safety and efficacy, it has become an essential asset to the medical community, being used to treat a range of cases from young children, military members and veterans, and seniors. 

Ketamine for mental health conditions

As research continued and scientific interest explored the uses of ketamine further, new applications and areas of efficacy were discovered.

Evidence from peer-reviewed, double-blind research over decades has shown that lower doses of ketamine prescribed in a clinical and therapeutic setting can provide benefits for depression and anxiety symptoms, among other mental health considerations.

Ketamine’s antidepressant and anti-anxiety benefits are related to enhanced neuroplasticity, or the ability of brain cells to form new connections with one another. The effects of ketamine therapy can be long-lasting, and often require shorter courses of treatment than medications like antidepressants.

Legal Ketamine-Assisted Therapy

One of the potential, and most illuminating, applications of ketamine is its use as a catalyst and treatment in managing or relieving depression and anxiety symptoms in patients actively suffering from these symptoms or who have been found to resist other possible treatments.

Therapeutic ketamine sessions, when prescribed and monitored by a licensed clinician, have the potential to facilitate incredible breakthroughs in the mental health of clients and patients who go through these treatments.

Ketamine is legal, safe, well-tolerated, and effective. This is due to decades of history in clinical and surgical environments, structures and systems in place for quality control, prescription and clinician regulations.

If you’re interested in learning how ketamine can help with anxiety and depression symptoms, take our assessment to see if you’re a candidate today.

When is ketamine illegal?

Ketamine is illegal when used outside of a clinically-prescribed setting.

Ketamine's illicit use as a “club drug” is known. It’s often referred to as special k, vitamin k, ket, kit kat, cat valium, and other street names. 

Side effects can include elevated blood pressure, increased heart rate, nausea, dizziness, and other symptoms. When used unsupervised recreationally, and in high doses, users can experience extreme dissociative effects, often called a “k-hole.”

This is why it’s important for users seeking medical and therapeutic benefits of ketamine to do so under medical supervision. When using the calculated dosage, in a clinically-supervised setting, ketamine therapy is safe and well-tolerated, allowing individuals to receive the intended benefit of the treatment.


This article is for informational purposes only and is not intended to be a substitute for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. If you are in a life-threatening situation, call the National Suicide Prevention Line at +1 (800) 273-8255, call 911, or go to the nearest emergency room.

Important FDA Safety Information

Ketamine is not FDA-approved for the treatment of depression or anxiety. Learn more about off-label uses here.

Side effects of ketamine treatment may include: altered sense of time, anxiety, blurred vision, diminished ability to see/hear/feel, dry mouth, elevated blood pressure or heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses).

Do not proceed with ketamine treatment if any of the following apply to you:

  • Allergic to ketamine
  • Symptoms of psychosis or mania
  • Uncontrolled high blood pressure
  • CHF or other serious heart problem
  • Severe breathing problem
  • History of elevated intraocular or intracranial pressure
  • History of hyperthyroidism
  • Other serious medical illness
  • Pregnant, nursing, or trying to become pregnant

Ketamine has been reported to produce issues including, but not limited to, those listed below. However, lasting adverse side-effects are rare when medical protocols are carefully followed.

While ketamine has not been shown to be physically addictive, it has been shown to cause moderate psychological dependency in some recreational users.

  • In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
  • Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders.
  • Users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your MindBloom® clinician before proceeding with treatment.
  • The dissociative effects of ketamine may increase patient vulnerability and the risk of accidents.

To promote positive outcomes and ensure safety, follow these ketamine treatment guidelines:

  • Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep
  • Refrain from taking benzodiazepines or stimulants for 24 hours prior to treatment
  • Continue to take antihypertensive medication as prescribed
  • Avoid hangovers or alcohol intake
  • Refrain from consuming solid foods within 3 hours prior to treatment and liquids within 1 hour prior to treatment
  • Ketamine treatment should never be conducted without a monitor present to ensure your safety

Exploring Psychedelic Treatment Options?

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