Ketamine Clinic Compliance Checklist 2026 - Regulations & Requirements

Obtain DEA registration for practice location (Form 224) Register for Schedule III controlled substances (ketamine) Ensure all prescribing providers have individual DEA numbers Establish secure storage for controlled substances Implement DEA-compliant inventory tracking system

HIPAA Compliance

Designate a Privacy Officer Conduct HIPAA risk assessment Develop Notice of Privacy Practices (NPP) Train all staff on HIPAA requirements Implement technical safeguards (encryption, access controls) Execute BAAs with all vendors handling PHI Establish breach notification procedures

State Requirements

Medical Licensing

Verify all providers licensed in practice state Obtain state controlled substance registration (if required) Check state board requirements for off-label ketamine use Review collaborative practice requirements for NPs/PAs Obtain facility license (if required by state)

PDMP Requirements

Register with state Prescription Drug Monitoring Program Understand state PDMP check requirements (many require check before prescribing controlled substances) Integrate PDMP with EHR (if available) Document PDMP checks in patient records

Controlled Substance Handling

Storage & Security

Install DEA-compliant locked storage (substantially constructed cabinet or safe) Limit access to authorized personnel only Maintain access log for controlled substance storage Install security system with alarm monitoring

Inventory Management

Conduct initial inventory upon opening Conduct biennial inventory (every 2 years) Maintain perpetual inventory records Track lot numbers and expiration dates Document all waste/disposal (witness required) Report thefts/losses to DEA within one business day

Clinical Documentation

Informed Consent

Develop ketamine-specific informed consent form Include off-label use disclosure (for depression/pain) Document risks, benefits, and alternatives Include driving restrictions (no driving day of treatment) Obtain signature before each treatment series

Treatment Documentation

Document medical necessity for ketamine treatment Record baseline vital signs before each treatment Document dose, route, and administration time Record monitoring observations during treatment Document patient status at discharge Track treatment outcomes (PHQ-9, etc.) over time

Emergency Preparedness

Establish emergency response protocols Maintain emergency equipment (oxygen, suction, AED) Stock reversal agents (benzodiazepines for emergence) Train staff in BLS/ACLS (appropriate to services) Establish hospital transfer protocols Conduct regular emergency drills

Software & Technology

Implement HIPAA-compliant EHR system Configure ketamine-specific documentation templates Set up ePrescribing with EPCS capability Integrate PDMP checking into workflow Implement patient outcome tracking (PHQ-9, GAD-7) Configure controlled substance inventory tracking

Ketamine Clinic Compliance Checklist

Consult Legal Counsel

Federal Requirements

DEA Registration