Is Ketamine Legal?
Plenty of patients considering ketamine therapy have wondered: is this legal? How does the legality of ketamine affect my 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 has plenty of legal uses  when it is prescribed by a medical professional. Some of these uses are more common than others, but all of them have extensive research backing their uses.
Ketamine was originally synthesized to be used as a sedative and anesthetic during surgical procedures. It gained FDA approved in 1970 and is commonly used by doctors and veterinarians to this day. It has been found to be one of the most effective and safe medications commonly used for procedural sedation whether in the Operating Room, the Emergency Room, or in austere or wilderness environments.
Ketamine has also been shown to be useful for the treatment of depression and anxiety with much lower doses than those used for procedural sedation. At these lower doses, patients do not lose consciousness or become dissociated, but they do experience some of the mind-altering affects that allows patients to form new neuronal connections that allows improves their moods, decreases both the depth and number of depressive episodes a patient experiences and alleviates anxiety.
FDA and DEA Scheduling of Ketamine
Ketamine is a regulated medication. It can only be legally used when it is prescribed by a licensed medical professional to ensure its appropriateness for the patient. Ketamine can be used as an anesthetic (a sedative and pain-reliever during surgery) or as part of therapeutical treatment for certain mental illnesses.
Ketamine has been approved by the Food and Drug Administration (FDA) as an anesthetic during surgical procedures and can be prescribed off-label by doctors. We discuss the term “off-label” further in the section below. The FDA approved the use of ketamine in medical contexts in 1970. In more recent years, the FDA approved a derivative known as esketamine in the treatment of depression for adults .
Ketamine is listed as a Schedule III drug in the Drug Enforcement Administration (DEA) guidelines . Any drugs that are classified as schedules I through V count as controlled substances. Controlled substances aren’t necessarily harmful; they just need to be closely monitored by a doctor. Their rating is the result of a combination of factors including the potential for mental or physical addiction, the accepted stance of the medical community, and the risk of adverse side effects. These drugs all require prescriptions to be legally used.
Schedule III classification means that the drug has been widely accepted by the scientific community as having medicinal value and it is not unusual for a clinician to prescribe it for patients. However, ketamine is only legal when prescribed by a licensed medical practitioner.
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 a anesthetic during surgical procedures. However, further research of 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, condition, it is referred to as ‘off-label use of ketamine’.
Off-label ketamine is completely 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 esketamine, a form of ketamine, for treating depression . 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 a medication to conduct 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.
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 . Recreational ketamine is often much more potent than the ketamine prescribed by doctors. Street ketamine is frequently used because of its hallucinogenic properties, but prescription ketamine is prescribed at a much lower dosage that typically does not cause any hallucinations.
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, you have nothing to worry about. 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 while a doctor monitors you during the process. They are there to ensure that you have the best experience possible and to answer any questions you might have during the experience.
Contact us today for more information about ketamine-assisted therapy and whether it is right for you.
Zhang MW, Harris KM, Ho RC. Is off-label repeat prescription of ketamine as a rapid antidepressant safe? Controversies, ethical concerns, and legal implications. BMC Med Ethics. 2016 Jan 14;17:4. doi: 10.1186/s12910-016-0087-3. PMID: 26768892; PMCID: PMC4714497.