The question “Is Ketamine legal?” comes up a lot. It's unfortunate there is such a misunderstanding of this drug's history of use and legal status.
Ketamine is a legally approved pharmaceutical agent. Its approval dates back to the 1960s. Ketamine infusion therapy has long been approved as a sedative-hypnotic anesthetic. Ketamine's legal use now spans six decades, proving its benefits as a “battlefield medicine,” rescuing injured soldiers from shock, trauma, and cardiovascular collapse from blood loss. Ketamine’s long safety record continues today.
Medical applications of Ketamine are venturing outside of combat and operating theaters. Effects useful in a diversity of clinical environments are attracting attention from both patients and providers. Ketamine is a legally approved anesthetic and is available for “off-label” prescription for other uses, including the treatment of mental health and severe pain conditions.
Medical personnel licensed to write prescriptions are required. Possessing Ketamine without a doctor’s prescription is illegal.
Like any substance used medically, illegal, recreational use is possible. Ketamine is no exception.
The illicit use of Ketamine, also called “Special K,” gained notoriety for its euphoric, dissociative effects, particularly in dance clubs. Its misnomer as a “party drug” comes from this context.
Ketamine is an invaluable anesthetic that appears on the World Health Organization's List of Essential Medicines.
However, its other uses are not explicitly approved but may be prescribed “off label.” Off-label use of pharmaceuticals is legal and common. When the FDA approves a drug, it is, for a specific use, an “indication.” Some medications have therapeutic applications not formally covered by the approval.
Licensed physicians have the freedom to use their judgment in prescribing a legal drug to treat different conditions. The permission to acknowledge and utilize pharmaceutical benefits without the constraint of the initial drug approval process equips clinicians with more treatment options. Off-label use is standard and practical. Estimations count the writing of off-label prescriptions at one in five.
Esketamine FDA approval
In 2019, Ketamine’s “mirror” molecule, “esketamine,” was approved by the FDA for Treatment-Resistant Depression (TRD).
The brand name of esketamine is Spravato™ and is an intranasal spray, not an infusion.
There are some differences between esketamine and ketamine, and while Ketamine infusions are legal when prescribed by licensed physicians, they are not yet officially approved by the FDA for treating depression or other conditions. Studies on the effectiveness and safety of Ketamine for the treatment of a multitude of conditions like depression, anxiety, and PTSD are ongoing and show promising results. The FDA approval of Spravato™ for depression sets an encouraging precedent.
Ketamine may be prescribed and administered by any licensed clinician.
Ketamine treatment centers are required to meet all licensing and regulatory standards to operate their outpatient medical practice. Qualifications and insurance guidelines may vary by state.
If a referral is necessary, it generally comes from the physician treating the condition for which you seek Ketamine. If you don’t already have a doctor, any prescribing physician can prescribe legal Ketamine. Coordination with your existing medical team is recommended.
What’s next for Ketamine?
Ketamine has potential but is it ready for wide use? Many medical professionals agree that Ketamine has potential beyond its historical uses. Due to its long history, Ketamine’s safety parameters are well-understood. However, those applications are comparatively brief (anesthesia, peri-surgical analgesia, shock from injury).
The next set of questions relates to the long-term use for conditions like depression, PTSD, Chronic Regional Pain Syndrome, neuropathy, and substance abuse. Long-term effects of repeated treatments in these contexts need time to manifest. Questions such as when to prescribe Ketamine, at what dose, and over what period are under investigation.
Studies looking at Ketamine’s off-label deployment are generally positive but small in size. Moderate clinical evidence supports a sensible deployment of this innovative treatment.