Is Ketamine Legal?
A common and legitimate question that circulates often is: "Is ketamine legal?" Here's exactly what you need to know as you explore the option of of psychedelic medicine and alternative treatments for anxiety and depression.
The short answer: Yes
The longer answer: Ketamine has FDA approval as an anesthetic and can be legally prescribed “off-label”(meaning, at the discretion of the clinician) to treat anxiety and depression.
The History of Medical Use of Ketamine
Early Uses of Ketamine
Ketamine was first approved by the FDA for medical use in 1970 as an anesthetic. At the time, ketamine was one of the safest anesthetic agents available, due to its ability to provide effective sedation and analgesia without compromising airway reflexes or respiratory functioning.
While the emergence of new anesthetic agents in the 1990s led to a reduction in the use of ketamine, the compound remains widely used in clinical settings today.
The use of ketamine as an anesthetic is particularly advantageous in patients with hemodynamic instability, patients with active bronchospasm, and pediatric patients, as well as in trauma medicine. Ketamine is also frequently used in emergency medicine for procedural sedation, relief of acute pain, and management of postoperative pain; as well as for the management of chronic pain.
Newer, Alternative Uses of Ketamine
Low-dose ketamine to treat depression and anxiety is a newer, off-label use of the drug. Medical professionals and researchers began noticing and studying ketamine’s ability to rapidly alleviate depression and suicidal thoughts around 2000.
Studies conducted over the next several years indicated that ketamine could be a promising and viable alternative treatment for depression. Starting in 2008, an increasing number of clinicians began to prescribe ketamine off-label for the treatment of depression and other mental disorders.
In 2019, the FDA approved the use of the S-enantiomer of ketamine, esketamine, as a nasal spray for the indication of treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior, in conjunction with an oral antidepressant.
Ketamine and DEA Scheduling
Ketamine is a controlled substance, meaning its use and distribution is tightly regulated by the Federal Drug Enforcement Administration (DEA). The DEA classifies drugs into one of five categories, called schedules, based upon their acceptable medical uses and the level of risk for potential abuse they carry. Schedule I drugs having the highest potential for abuse, and Schedule V drugs having the lowest abuse potential.
Ketamine is classified as a Schedule III substance, meaning it has established value for medical purposes and a “moderate to low potential for physical and psychological dependence.”
What is “Off-Label” Prescribing? Is This Still Legal?
Currently, ketamine is being prescribed off-label by clinicians for a variety of diagnoses, including anxiety disorders, depression, substance abuse, and pain-relief. But what does “off-label” prescribing mean? Is it still legal?
Off-label prescribing refers to a practice wherein a physician prescribes a patient an FDA-approved drug for a different condition than what the medication is officially approved for.
When a drug is approved by the FDA, it usually is indicated as a treatment for a very specific disease or condition. However, once a medication is approved, physicians are able to prescribe it for other purposes they believe to be medically appropriate based on their clinical judgment.
Off-label prescribing is extremely common and legal, so long as it's prescribed by a licensed practitioner for a specific use. In fact, about one in five prescriptions written today are for an off-label use. For example, Gabapentin is a medication that is approved to repeat seizures and nerve pain, and today, it is commonly prescribed to treat a wide range of additional conditions, including bipolar disorder and migraines.
Prescribing Ketamine via Telemedicine
Telemedicine refers to the remote diagnosis and treatment of patients, allowing the delivery of healthcare without an in-person office visit.
Since the early 2000s, the use of telemedicine has risen steadily. The onset of the COVID-19 pandemic in 2020 led to an even greater surge in telemedicine usage, and resulted in the lifting of various prior telemedicine restrictions by both federal and state governments.
One such change specifically related to the prescription of controlled substances like ketamine has been a lifting of regulations outlined by the Ryan Haight Online Pharmacy Consumer Protection Act, a 2008 amendment to the Controlled Substance Act of 1970. Historically, under this act, healthcare providers could not prescribe controlled substances to patients without first conducting an in-person medical evaluation (except in certain specified circumstances).
However, the ongoing federal Public Health Emergency (PHE) waived these key provisions in the act, allowing providers to prescribe Schedule II-IV drugs via means of the internet, so long as the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice; the telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and the practitioner is acting in accordance with applicable federal and state laws.
While the future of telemedicine regulations after the expiration of the current PHE aren’t entirely certain, an increasing number of states are moving towards maintaining expanded telehealth access into the future.
Though the landscape is rapidly evolving, one thing remains clear- telemedicine is here to stay. By providing patients with increased accessibility to quality healthcare services at a lower cost, telemedicine has become an important means of care delivery, and will continue to play an essential role in the future of medicine.
When is Ketamine Illegal?
Ketamine is illegal as a recreational drug and outside of any clinically prescribed setting.
Ketamine has a reputation for its illicit use as a club drug due to the side effects at high dosages including: nausea, dizziness, increased blood pressure, increased heart rate, and extreme dissociation effects often referred to as a "k-hole."
When considering ketamine for medical and therapeutic purposes, it's important to seek the care of a medical professional. Calculated dosages of ketamine under proper supervision is a safe and highly effective alternative treatment for mental health conditions such as anxiety, depression, and PTSD.
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