In recent years there has been a dramatic increase in the focus on wellbeing and therapy and recognition that many forms of trauma and depression can be resistant to conventional treatment and medications. In response, psychedelic-related therapies, such as the use of ketamine, have become more popular. Ketamine, which was once used primarily as a recreational drug, is now being administered in clinics throughout the United States to treat patients suffering from trauma, pain and depression.

Background

Ketamine is a Schedule III controlled substance (i.e., a substance with a moderate to low potential for physical and psychological dependence). While ketamine was approved in 1970 as an injectable anesthetic for certain diagnostic and surgical procedures, in 2019 the Food and Drug Administration (FDA) approved the nasal spray, Spravato (esketamine, an enantiomer of ketamine), for treatment-resistant depression and depressive symptoms associated with acute suicidal ideation or behavior in adults. Because the use of ketamine is emerging in a complex legal and regulatory environment, health care providers should be aware of, and ensure compliance with, the legal and regulatory landscape surrounding the use of ketamine. This article provides a summary of the basic legal requirements, cautionary considerations, and additional recommendations with regard to the use and intranasal administration of ketamine that health care providers and ketamine clinics should follow.

Minimum Requirements