How Does the DEA Classify Ketamine
Ketamine is a Schedule III controlled substance under the federal Controlled Substances Act. Its scheduling reflects a regulatory determination, made and maintained through the DEA’s classification authority, that ketamine has a currently accepted medical use in treatment in the United States and a potential for abuse less than the substances or other drugs in Schedules I and II.
The placement of ketamine in Schedule III, rather than Schedule II where most opioid analgesics and stimulants reside, has significant practical implications for the practitioners who prescribe it, the facilities that dispense it, and the regulatory framework that governs its clinical use. Schedule III substances carry less stringent prescription requirements than Schedule II: prescriptions may be telephoned to a pharmacy, may be refilled up to five times within six months, and carry somewhat less intensive DEA monitoring than Schedule II prescriptions. Those relatively lighter restrictions reflect the scheduling determination, not an absence of DEA oversight.
The Historical Context of the Scheduling Decision
Ketamine was introduced as an anesthetic agent in the 1960s and gained DEA scheduling as a Schedule III controlled substance in 1999, following recognition that the drug was being diverted for recreational use in club settings as a dissociative hallucinogen. The scheduling decision placed ketamine under controlled substance regulatory requirements for the first time, imposing DEA registration requirements on practitioners who prescribe it and record-keeping requirements on facilities that maintain it.
The 1999 scheduling has remained unchanged despite subsequent recognition of ketamine’s therapeutic applications beyond anesthesia, including its use in treatment-resistant depression, suicidal ideation, PTSD, and chronic pain. The DEA’s scheduling classification does not reflect current clinical understanding of all of ketamine’s potential therapeutic uses; it reflects the regulatory determination made at the time of scheduling, which is updated only through formal DEA rulemaking proceedings.
Schedule III Requirements for Practitioners
A practitioner who prescribes ketamine must hold a valid DEA registration that authorizes the prescribing of Schedule III controlled substances. The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, the same standard applicable to all controlled substance prescriptions under 21 C.F.R. 1306.04. The usual course of professional practice standard for ketamine prescribing is assessed against the evolving clinical standards applicable to the specific therapeutic use for which ketamine is being prescribed.
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(212) 300-5196Ketamine prescribing does not require any special DEA authorization beyond the standard Schedule III prescribing authority included in a practitioner’s DEA registration. The practitioner who has a DEA registration that includes Schedule III authority, who prescribes ketamine for a legitimate medical purpose within their clinical scope of practice, and who documents the clinical basis for the prescription has met the basic regulatory requirements for ketamine prescribing.
The Distinction From Schedule II
The Schedule III classification of ketamine distinguishes it from the Schedule II opioids that have been the primary focus of DEA opioid enforcement. Schedule II substances require written prescriptions that cannot be refilled, carry more intensive PDMP reporting in many states, and receive more intensive DEA monitoring through the ARCOS system than Schedule III substances. Ketamine’s Schedule III status means that its prescribing is subject to meaningful but less intensive regulatory oversight than Schedule II opioids.
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The Schedule III classification does not mean ketamine is unmonitored. It means ketamine is monitored differently than Schedule II substances. The DEA’s investigation of ketamine diversion, discussed in subsequent articles, applies the same legal standards as its investigation of opioid diversion: the prescription must be issued for a legitimate medical purpose within the usual course of professional practice. The scheduling affects the regulatory requirements; it does not affect the legal standard for evaluating whether the prescribing is legitimate.
Rescheduling Considerations
The DEA retains authority to reschedule ketamine through the formal rulemaking process if the evidence of abuse potential, medical use, and safety characteristics warrants a scheduling change. The growth of ketamine infusion clinics and the expansion of off-label ketamine prescribing have generated some discussion of whether a scheduling review is warranted, both by proponents of rescheduling to Schedule II to impose greater oversight and by proponents of maintaining or relaxing the current Schedule III classification. No formal rescheduling proceeding has been initiated as of the time of this writing, and ketamine remains a Schedule III substance.
