Legality of Ketamine
In the United States, ketamine is a Schedule III substance under the Controlled Substance Act, meaning it has a low to moderate potential for physical and psychological dependence. Other examples of Schedule III substances include products containing less than 90 mg of codeine per dosage unit (Tylenol with codeoregonine), anabolic steroids, and testosterone. To obtain ketamine, the prescribing physician must have an active DEA license. The use of ketamine for psychotherapy is a permitted off-label use by a prescribing physician.
Ketamine was approved by the FDA as an anesthetic agent back in 1970. Although favorable research focused on ketamine for treatment-resistant depression, the patent expired in 2002 making the clinical trial process for any additional FDA-approved indications not cost effective as a generic drug with no patent protection.