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Frequently Asked Questions
Yes. Ketamine is a Schedule III controlled substance under the U.S. Controlled Substances Act (CSA), a classification the DEA assigned in 1999. Its FDA-approved S-enantiomer, esketamine (marketed as Spravato), carries the same Schedule III status. This ketamine controlled substance classification places the drug in the same broad regulatory tier as buprenorphine, testosterone, and codeine-containing combination products: recognized as having accepted medical use, but subject to federal recordkeeping, prescribing, and dispensing rules because of its potential for dependence.
Understanding what Schedule III actually requires, and what it does not, helps patients and clinicians separate legitimate regulatory concerns from the confusion that often surrounds ketamine's legal status. This guide explains the classification, how it compares to the other four federal drug schedules, and how it shapes prescribing and access today.
Quick Answer
Ketamine is a Schedule III controlled substance under the federal Controlled Substances Act, a status the DEA assigned in 1999. Schedule III drugs have accepted medical uses and a moderate to low potential for physical dependence, lower than Schedule I or II substances like heroin or oxycodone. This classification requires prescribers to hold DEA registration and limits prescriptions to five refills within six months. Esketamine (Spravato) carries the same Schedule III status but is dispensed only through certified healthcare sites under an FDA risk management program.
The Controlled Substances Act (CSA) is the 1970 federal law that classifies regulated drugs into five schedules based on medical use, abuse potential, and dependence risk. The U.S. Drug Enforcement Administration (DEA) is the federal agency that administers these scheduling decisions and oversees registered prescribers, pharmacies, and manufacturers.
Schedule III is defined by three criteria: the substance has a currently accepted medical use in the United States, its potential for abuse is lower than substances in Schedule I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence, according to the CSA's statutory schedule definitions at 21 U.S.C. Section 812.
According to the DEA's drug scheduling guidance, Schedule III substances have a potential for abuse less than the drugs or other substances in Schedules I and II, while still requiring federal registration to prescribe, dispense, or manufacture.
Ketamine was placed on Schedule III in 1999, nearly three decades after the FDA approved it as a surgical anesthetic in 1970. The scheduling decision reflected documented recreational misuse and diversion for non-medical use, alongside the drug's continued legitimate medical role in anesthesia and, later, mental health treatment. For the full sequence of events, see our ketamine history timeline.
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