Is Ketamine Legal?

Ketamine is legal and has a long history in medicine. In fact, because of ketamine’s long-established use cases, modern practitioners have a deep understanding of how to use ketamine safely.

Ketamine was synthesized in 1962 and approved for use in the United States in 1970. Initially, ketamine was used as a dissociative anesthetic for surgery on the battlefields of the Vietnam War. Ketamine has also been commonly used in veterinary medicine, as you might have heard, as a horse tranquiliser. While using an anesthetic for humans and horses for mental health treatment might seem odd, it is normal for drugs to have multiple uses that benefit humans and animals.

Today, ketamine is recognized for its therapeutic value, with effects like neuroplasticity and anti-inflammatory properties producing rapid and impressive results. Some have even speculated that the dissociative effects of ketamine are therapeutic, although this is still debated. These explorations are ushering in a new understanding that ketamine can be a valuable tool for mental health conditions like depression, anxiety, and addiction, along with a tool for greater wellness for others.

The shifts ketamine creates in some people leave a lasting impact on many lives and inspire the curiosity of practitioners, researchers, and people looking for new treatments for mental health.

Where is Ketamine Therapy Legal?

Ketamine in the US and around the world generally is legal, but because of problems with recreational use, often under the same “Special K,” ketamine is a controlled substance. This means ketamine production and distribution are carefully monitored in countries like the United States, Canada, Australia, and many parts of Europe.
Yet, as a controlled substance, ketamine is still available legally in every state and many countries around the world. Ketamine can even be made available as a prescription for at-home use. Like many other drugs, ketamine's effects are powerful and therefore are only legally allowed in specific circumstances under qualified supervision.

The dangers of misuse are known in China, which has proposed an international ban on ketamine. The proposal has been met with considerable pushback worldwide, particularly as its accepted medical uses are apparent. However, China is in a difficult situation as a great deal of black-market ketamine is produced in the country, leading to serious abuse problems.

Is Ketamine Addictive?

China’s situation is a prime example of why ketamine recreational use is illegal. Ketamine is a “Class 3” controlled substance, meaning it has a moderate-low potential for physical dependence with a higher risk for psychological dependence. Ketamine is on the lower half of the four-point scale, rating how dangerous drugs are alongside many other common prescriptions. As a medication, ketamine is addictive only when misused. For example, if ketamine is snorted as a powder, addiction can occur. However, the use of sublingual or ketamine infusions have not shown signs of addiction to date.

Even with oral ketamine, a craving for improvements in one's life can occur. Indeed, a better life is why people seek ketamine treatment. To help with these desired changes, trained professionals are needed alongside ketamine use. The combination of using the medication as prescribed with the support of a practitioner is how therapeutic benefits are safely realized.

Are Ketamine Clinics Legal?

As ketamine is a controlled substance, it is often administered in clinics. These locations give people high doses of ketamine to have sometimes transformative “psychedelic” experiences. Typically these are with ketamine infusions, an injection of ketamine administered by healthcare professionals qualified to work with ketamine.

For many people, this creates a “window of opportunity,” meaning there is a chance to create new neural pathways in their brains, which can help shift one's perspective. This window can last about ten days, during which people can experience powerful changes, but sometimes old habits come back, and more treatment is needed. Ketamine clinics usually require several treatments over many weeks in combination with ongoing therapeutic support.

At-Home Ketamine Therapy

Ketamine’s effects don’t need to be limited to clinics, however. Ketamine telehealth companies have shown that at-home ketamine telehealth can be safe and effective, even at higher doses. Instead of having ketamine injections, oral ketamine in the form of lozenges is mailed to patients, who are then supported through psychedelic ketamine journeys via an online platform.

Taking a high dose of ketamine at home in front of the computer is understandably not everyone’s cup of tea. To make ketamine accessible, various ketamine protocols are now emerging. Joyous has developed a very low-dose ketamine protocol with telemedicine support. Instead of entering a highly disassociative state known as “the K-hole,” the Joyous app optimizes frequent very low doses of oral ketamine to sustain positive changes rather than needing to return to the clinic for ketamine injections.

Is Ketamine Telemedicine Legal?

Telemedicine was made legal during the Covid-19 pandemic. Permissions granted under the Public Health Emergency allowed patients access to medications without completing in-person meetings with their healthcare providers, which are typically required. During this time, companies like Mindbloom had already been operating in-person ketamine clinics. When telemedicine became approved, a new opportunity was created to open greater access to ketamine, including the permission to mail controlled substances across state lines.

Even with the Covid-19 pandemic behind us, telemedicine has stayed. Laws about in-person meetings were created by the Ryan Haight Act in 2008 to counter online drug trafficking. But now, access to healthcare has been granted to far more people, and many groups are calling for telemedicine options to be a standard of care.

Ketamine FDA Approval

Initially, in the United States, the Food, Drug, and Cosmetic Act, established in 1938, only required pharmaceutical companies to show new medications were safe. The act was amended in 1962 to include drugs should also be effective. The focus on providing evidence drugs could treat certain conditions is time-consuming and expensive.

While drugs have many different uses, the FDA approval process means developers must focus on specific outcomes, which are “on-label.” Drug manufacturers can then market their products based on these proven outcomes. Ketamine is an old drug with parameters for safe use well established from longstanding FDA approval. However, its use as a mental health treatment is not its established use as an anesthetic.

Potential for mental health treatment was observed over 20 years ago when researchers found antidepressant effects of ketamine in depressed patients and that low doses of ketamine helped some post-surgery. The realization of the significance of this discovery has taken time to be appreciated. Now a shift is occurring with ketamine treatment for depression, anxiety, addiction, and chronic pain is leading to an increase in its use as an “off-label” drug.

What Does Off-Label Mean?

Off-label means that practitioners are giving ketamine for a different use than it was initially studied and approved for. Off-label can be a difference in the condition a drug is treating, the method it is delivered, or the dosage. The practice is widespread, and it was reported in 2006 that 21% of prescriptions were off-label use. The overall number is also likely higher, and for certain conditions, the vast majority of prescriptions are off-label.

Medical practitioners are legally allowed to prescribe off-label drugs. The FDA has made it clear they do not regulate the practice of medicine, and current legal precedents are centred around off-label prescriptions being a “matter of medical judgment.” This suggests legal claims based on ketamine not being FDA approved would not stand up in court, barring accusations of malpractice.

Are Ketamine Off-Label Uses Safe?

Many drugs have side effects. Depending on how a drug is used, some effects are beneficial while others are problematic. For example, when you are doing a very low-dose ketamine protocol, taking a dose that makes you hallucinate isn’t beneficial. In a clinic with an anesthesiologist, a psychedelic dose of ketamine is the goal.
All that is to say that ketamine is a very safe drug when used correctly. This means following ketamine protocol instructions is essential to see improvement. Treatment of depression, anxiety, addiction, or PTSD with a drug like ketamine is a serious process with huge potential upsides. Many have changed their lives with ketamine, yet this has happened in carefully thought-out, supportive environments with well-researched and safe protocols.

Legal Ketamine and the Rise of Online Treatment

Ketamine is well-positioned to help many people. As an established safe medicine, ketamine clinics are now available all over the world. The widespread acceptance of telemedicine at-home ketamine therapy is allowing far greater access to ketamine and mental health support.
Off-label ketamine, when used in safe and supportive settings, represents the potential to create immense benefits for people seeking relief from depression, anxiety, addiction, and PTSD. While ketamine was not originally developed as a mental health treatment, but its long history of use makes it an attractive option alongside emerging research.

The variety of protocols being developed shows promise of having a treatment option for anyone who is interested and can safely use ketamine. From high-dose intravenous infusions in luxury clinics to affordable at-home options, ketamine is proving to be an unlikely but potent force opening up fascinating new opportunities on the mental health landscape.

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