Ketamine is an FDA-approved anesthetic, but is also legal for use by registered practitioners for mental health as an “off-label” prescription. It is regulated, meaning only licensed clinicians with the authority and experience to support its effective usage can administer or prescribe treatment. Any use of ketamine outside of these guidelines is illegal.
“Off-label” means the medication is used to treat something outside of its original medical intent – for ketamine, as an anesthetic. Of note, up to a third of all prescriptions are made off-label and is considered safe practice by licensed prescribing practitioners. The reasons for not getting “on-label” status are related to the costs of needing to conduct additional research studies before formal FDA approval. Ketamine, for example, is an old drug which is no longer patentable in its original form, leading to a lack of funding for the studies needed for formal on-label approval studies. However, there are many studies which show that it is indeed effective for several mental health diagnoses, and very safe.
The Drug Enforcement Administration has listed ketamine as a Schedule III compound. Any compound with a rating between 2-5 is designated to have a viable medical use and is legal to administer through a licensed clinician to treat a specific condition.
When used as a “club drug,” ketamine is illegal. Side effects of this unregulated use are often elevated blood pressure, increased heart rate, nausea, dizziness, and extremely strong dissociative symptoms, referred to as a “k-hole.”
This is why it's critical for people who want to utilize ketamine for therapeutic purposes to do so under clinical supervision. Ketamine therapy is safe and well-tolerated when used at the proper dosage in a clinically supervised context, allowing users to receive the treatment's intended benefit.
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