Where Is Ketamine Legal? Everything You Need To Know
The hype around ketamine, a very promising psychedelic, is real. So where is ketamine legal, exactly? We explain everything that you need to know.
The U.S. alone has seen a proliferation of ketamine clinics in the last five years, with very big jumps in numbers happening month after month. Not only are people becoming more interested in learning about ketamine and how it can help them with their long-term issues, but the health care provider community seems to be keen on exploring various alternative therapies and emerging medicines to improve quality of care.
With two existing ketamine treatment options (ketamine as a nasal spray, esketamine, and IV therapy), the FDA has different approaches. They approved the nasal spray (although it’s only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS), but decided against doing so for ketamine IV therapy. That said, is ketamine legal as IV therapy then?
Off-label Use Of Ketamine
Ketamine therapy falls under “off-label use”. This means a person is using it for a condition without approval. This often happens with chemotherapy while treating different types of cancer.
Ketamine infusions are only OK to use as a sole anesthetic agent for diagnostic and surgical procedures. This does not mean they cannot be used for other indications. Off-label ketamine for the treatment of mental health issues, mood disorders, and pain has medical support. Plus, research is constantly growing and is receiving funding.
Therefore, ketamine can be administered for indications outside of its FDA-approved indications — but only if it’s consistent with medical standards and regulations. More specifically, careful practice of evidence-based medicine by appropriately-trained physicians.
So what does this exactly mean for ketamine clinics? Are they doing something wrong by administering infusions, or should they stick to esketamine? The Drug Enforcement Agency (DEA) has five categories or schedules for all medicine: Schedule I, Schedule II, Schedule III, Schedule IV, and Schedule V.
Drugs are scattered amongst various categories based on medical uses and dependency potential. Schedule I drugs have high dependency potential (developing addiction), with no current medical use. Schedule II drugs often have some medically accepted uses, with a progressively decreasing potential for developing addiction.
Ketamine falls under Schedule III, which means that it has a moderate potential for physical and psychological dependence. For reference, Tylenol with Codeine, buprenorphine, and testosterone are also Schedule III drugs.
Is ketamine legal to obtain from a pharmacy? Yes, so long as anyone administering it all have a DEA license. Since the treatment is from an outpatient clinic, it has standard outpatient requirements. These are below.
- State medical board licenses
- Insurance coverage
- OSHA standards
- The ability to store and take care of controlled substances
- Must obtain county/city licensing
Beyond that, there are no other regulations for ketamine infusions clinics. That’s why, over the years, those working with ketamine have come up with some suggested guidelines, like the consensus statements in JAMA Psychiatry and Regional Anesthesia and Pain Medicine, and organizations such as Kriya Ketamine Research Institute and the American Society of Ketamine Practitioners which are working hard on bringing together like-minded doctors, psychologists, and nurses to share experience, information, and provide education on the latest evidence-based research, studies, and treatments.
Is Ketamine Legal Outside Of The U.S.?
Ketamine clinics in the U.S. aren’t the only places administering ketamine. There are plenty of countries worldwide which are trying to get the best out of this psychedelic.
- Dr. Scheib’s clinic operates in both Germany and Spain. Each offers ketamine for depression, using repetitive transcranial magnetic stimulation (rTMS), neurofeedback, hypnosis and psychotherapy.
- The UK offers ketamine treatment for depression, but only for those who don’t respond to other treatments with a paid-for service.
- Ketamine has even become available in Czech Republic in a health center that focuses primarily on psychedelic-assisted psychotherapy and psychotherapeutic counseling.
Many health care providers see ketamine as a new, non-invasive and alternative treatment. This may help patients after attempting all evidence-based options without yielding results.
Is ketamine legal? At its core, yes. However, ketamine infusions are still awaiting full approval. With a plethora of studies ongoing, the possibilities are endless for the near future. Should more positive results return, the legalities around the psychedelic treatment will shift.