Is Ketamine Legal? A Global Guide to Ketamine’s Official Status

Once used as an anesthetic in hospitals and on battlefields, ketamine is now one of the most talked-about substances in mental health care. With fast-acting antidepressant effects and a growing body of support from patients and doctors, ketamine is being used in therapeutic settings around the world.

But is it legal? And if so, where, and under what conditions?

This guide breaks down the current legal status of ketamine across the globe, examining its FDA approval, off-label use, and more.

Brief History of Legal Ketamine

First synthesized in the 1960s, ketamine received FDA approval as an anesthetic in 1970. Its rapid onset and safety profile made it a go-to option in surgical and emergency settings. During the Vietnam War, it was heavily relied upon by medics for its effectiveness in sedating injured soldiers without the need for advanced monitoring equipment.

Ketamine holds a unique position within the landscape of psychedelic medicines. Unlike other psychedelics such as psilocybin or LSD — which remain classified as Schedule I substances and are still heavily restricted — ketamine is legally available for medical uses in many jurisdictions and is actively used in clinical settings.

In addition to its established use as an anesthetic, it is widely administered “off-label” for a range of psychiatric conditions, offering therapeutic options that aren’t yet accessible with other psychedelics.

How is Ketamine used?
Medical ketamine can be administered in several forms depending on the setting and purpose. Common methods include intravenous (IV) infusions, intramuscular injections, intranasal sprays like Spravato, and oral lozenges or tablets. IV and intramuscular routes are typically used in clinics, while lozenges are common in at-home telehealth therapy programs.

Off-Label Prescription of Ketamine

Off-label prescriptions are a common and legal practice in medicine. It allows doctors to use approved drugs for conditions other than those they were originally approved to treat.

In the case of ketamine, this means that while it is officially approved for anesthesia, clinicians can legally prescribe it for depression, PTSD, anxiety, bipolar disorder, and more, based on a growing body of evidence.

What is off-label drug use?

Prescribing an FDA-approved medication for a purpose other than its original approved indication. While the FDA (or other government bodies) regulate drug approval, it doesn’t control how doctors prescribe medications. This means clinicians can legally prescribe approved drugs — like ketamine — for other conditions based on clinical judgment and emerging research, even if those uses haven’t been formally endorsed by the FDA.

Is Ketamine Legal in the U.S.?

Ketamine is considered illegal for personal use, but legal for medical use in the United States. It is classified as a Schedule III controlled substance under the Controlled Substances Act, meaning it is approved for medical use but monitored due to the potential for abuse.

Clinics across the U.S. offer ketamine infusions and lozenges for off-label treatment of mental health conditions. It is estimated that over 1,000 clinics are operating legally in the U.S., providing supervised ketamine therapy (these clinics and providers are prescribing ketamine using the “off-label” method described above).

Is Ketamine Legal in the UK?

The UK’s landscape for legal ketamine is similar to the U.S. In the United Kingdom, ketamine is legal for medical use, including off-label administration for psychiatric care. Spravato is also licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for treatment-resistant depression.

In 2014, the UK government reclassified ketamine from a Class C to a Class B drug under the Misuse of Drugs Act. This increased the penalties for unauthorized possession, trafficking, and recreational use, which remains strictly prohibited.

Private clinics may offer ketamine infusions for mental health treatment under a doctor’s supervision, provided they adhere to licensing and controlled substance regulations.

Is Ketamine Legal in Europe?

Ketamine’s legal status varies across Europe, with most countries permitting medical use under strict regulation:

Germany: Permitted for medical use with prescription. Recreational use is illegal.
Czech Republic: Permitted for medical use with prescription. Personal possession of small amounts is decriminalized.
Portugal: All drugs have been decriminalized for personal use, including ketamine.
Spain: Permitted for medical use with prescription. Personal use is decriminalized for small amounts but fined if used in public.
Netherlands: Allows regulated therapeutic ketamine use in mental health treatment centers. Recreational use is illegal.

Across Europe, legal medical use of ketamine is expanding in private and hospital-based clinics, though recreational use remains widely banned. Be sure to verify the legality of your jurisdiction and keep in mind, tha transportation of ketamine between countries is illegal.

Is Ketamine Legal in Asia?

Most Asian countries have strict drug laws, and ketamine is either illegal or heavily restricted. Be sure to verify the legality of your jurisdiction.

China: Ketamine is banned due to widespread recreational misuse and trafficking concerns.
Japan: Permitted for medical use with prescription. Treatment in private clinics is limited but available. Recreational use is illegal.
India: Permitted for medical use with prescription. Treatments in private clinics available. Recreational use is illegal.
Singapore: Permitted for medical use with prescription. Treatment in private clinics is limited but available. Recreational use is illegal.
Thailand: Permitted for medical use under strict regulation. Treatment in private clinics is limited but available. Recreational use is illegal.
Indonesia: Permitted for medical use under strict regulation. Treatment in private clinics is limited but available. Recreational use is illegal.

Legal Ketamine: Rest Of The World

Here’s a look at some other major jurisdictions around the world. Be sure to verify the legality of your jurisdiction.

Canada: Permitted for medical use with prescription. Treatment in private clinics available. Recreational use is illegal.
Australia: Permitted for medical use with prescription. Treatment in private clinics available. Recreational use is illegal.
Costa Rica: Permitted for medical use with prescription. Recreational use is illegal.
Mexico: Permitted for medical use with prescription. Recreational use is illegal.
Brazil: Permitted for medical use with prescription. Treatment in private clinics available. Recreational use is illegal.

Spravato: Another Legal Ketamine Option

In 2019, the FDA took a major step by approving Spravato (esketamine), a ketamine derivative, as a nasal spray treatment for adults with treatment-resistant depression. Unlike traditional ketamine, Spravato is patented and must be administered in a certified medical office under supervision.

Produced by Janssen Pharmaceuticals (owned by Johnson & Johnson), Spravato approval was a milestone for the industry — the first-ever psychedelic drug approved for mental health treatment. In 2025, the FDA continued its support for this ketamine therapy, as they approved Spravato as a monotherapy, meaning this ketamine therapy can be taken alone and not in conjunction with SSRIs or other antidepressants.

Spravato is also available, with prescription, in other countries like Canada, Australia, and the UK.

Legal Ketamine for Telemedicine

The rise of ketamine telehealth has opened up new possibilities for legal access, especially in countries like the United States and Canada. Companies are using legal frameworks for digital health to offer ketamine lozenges prescribed after virtual assessments and paired with remote integration therapy.

However, this emerging model also presents concerns about oversight. Critics warn about the lack of standardized guidelines, potential overprescribing, and inconsistent integration with psychotherapy. While telehealth offers accessibility, strong clinical standards are needed to ensure safety and therapeutic benefit.

Ketamine is one of the only psychedelic-style treatments legally available today, and its global legal landscape reflects a complex mix of medical potential and regulatory caution. As research continues and demand for psychedelic therapies grows, ketamine’s legal status may continue to evolve — making it essential for patients, providers, and policymakers to stay informed.

* Ketamine access is increasing, but its legal status is evolving and varies around the world. Be sure to verify the legality of your jurisdiction.

For more details on ketamine uses, risks, and benefits, see our comprehensive ketamine guide here:

Ketamine for Mental Health: A Deep Look into Science-Based Treatment

Jason Najum

Jason Najum is a Senior Editor & Creative Producer at States of Mind. He's held senior editorial roles at Microdose and Psychedelics.com, and was a regular contributor to The Huffington Post, Seeking Alpha, National Geographic, and Lonely Planet.