Yes. Any practitioner who prescribes, administers, or dispenses ketamine in the course of their professional practice must hold a valid DEA registration that authorizes the handling of Schedule III controlled substances.
The DEA registration requirement applies to every practitioner who writes ketamine prescriptions, who administers ketamine in a clinical setting, or who maintains ketamine in a clinical facility’s controlled substance inventory. The requirement applies regardless of the specific therapeutic use for which ketamine is being employed, whether anesthesia, pain management, treatment-resistant depression, or any other indication. The scheduling classification is what triggers the registration requirement, not the specific indication.
The Registration Application Process
A practitioner who does not already hold a DEA registration, or whose current registration does not include Schedule III authority, must submit a DEA Form 224 application to the DEA’s Diversion Control Division to obtain a registration that authorizes ketamine prescribing. The application requires the practitioner’s name and contact information, their state medical license number and expiration date, the business address at which they will prescribe, the drug schedule authorizations requested, and a certification that the information provided is accurate.
A practitioner who holds an existing DEA registration that includes Schedule III authority does not need to take any additional steps to prescribe ketamine. The Schedule III authority in an existing registration covers ketamine without any supplement or modification. The practitioner’s DEA registration number must appear on any ketamine prescription issued, and the prescription must comply with the Schedule III prescription requirements applicable under federal law and the laws of the state where it is issued.
Facility Registration Requirements
A clinical facility that maintains ketamine in its controlled substance inventory, administers it to patients, or dispenses it through a pharmacy requires its own DEA registration independent of any individual practitioner’s registration. Ketamine infusion clinics, outpatient surgical centers, and other facilities that administer ketamine must be DEA-registered, must maintain the inventory records and security measures required for Schedule III substances, and must comply with the DEA’s inspection authority over registered facilities.
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(212) 300-5196The distinction between individual practitioner registration and facility registration is practically significant: a practitioner may use their individual registration to prescribe ketamine that is dispensed by a registered pharmacy, but they may not administer ketamine at a facility that is not independently registered unless the facility’s registration covers the administration. A ketamine infusion clinic that administers the drug must have its own registration, and the administrator’s individual registration does not substitute for the facility’s registration requirement.
Registration in Multiple States
A practitioner who prescribes ketamine in more than one state typically needs a DEA registration in each state, because DEA registrations are tied to the specific practice location at which the controlled substances are handled. A practitioner who holds a DEA registration in Texas cannot use that registration to prescribe ketamine at a clinical facility in Florida, even if they hold a medical license in both states. Practitioners who provide ketamine services in multiple states must confirm that their DEA registration covers each location where they practice.
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The registration requirement is the entry point for all DEA regulatory authority over a practitioner’s ketamine prescribing. A practitioner who prescribes ketamine without a DEA registration has violated the Controlled Substances Act in a manner that is independent of whether the prescribing was clinically appropriate. The administrative violation of prescribing without registration is, in some respects, easier for the government to establish than the clinical violation of prescribing outside the usual course of professional practice, because it requires only proof of the prescription and the absence of registration, without the medical expert contest that characterizes the clinical standard cases.
Federal agents execute a search warrant at your medical practice, seizing patient records and prescription logs.
Can they take patient records without patient consent?
A valid federal search warrant overrides HIPAA privacy protections. However, the warrant must be properly scoped. An attorney can challenge overly broad warrants and move to suppress improperly seized evidence.
This is general information only. Contact us for advice specific to your situation.
Maintaining Registration Compliance
A practitioner who holds a DEA registration for ketamine prescribing must maintain that registration through timely renewal, must update the DEA when the registration address changes, must comply with the DEA’s notification requirements if the registration is surrendered or suspended, and must comply with the record-keeping and security requirements applicable to Schedule III substances at each registered location. The administrative compliance with registration requirements is the foundation of the regulatory relationship with the DEA; its failure creates exposure that exists independently of the clinical quality of the prescribing.
