Compliance Hub

Compliance Made Simple

Navigate Narcotics Compliance With Confidence

DEA regulations. State requirements. Audit trails. Diversion prevention. MedixSafe automates every compliance requirement so you can focus on saving lives, not paperwork.

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DEA Compliance

State Regulations

Audit Trail

Access Control

Diversion Prevention

100%

Compliance Score

Federal DEA Requirements

Secure storage in substantially constructed safes
Complete audit trail of all access and transactions
Immediate reporting of theft or loss
2-person authentication for Schedule II drugs
Regular inventory reconciliation

State-Specific Regulations

Vary significantly by jurisdiction
Additional reporting requirements
Stricter access control standards
Enhanced security for certain drug classes
State audit and inspection protocols

Operational Challenges

High-stress emergency environments
Multiple staff members accessing safes
Shift changes and handoffs
Expired medication tracking
Diversion and theft prevention

Secure Storage (21 CFR § 1301.75)

Controlled substances must be stored in "securely locked, substantially constructed cabinets."

MedixSafe Solution

All MedixSafe units are DEA-compliant with reinforced steel construction, anti-pry mechanisms, and tamper detection.

Complete Audit Trail (21 CFR § 1304.04)

Maintain complete records of all controlled substance transactions, acquisitions, and disposals.

MedixSafe Solution

Automatic logging of every safe access, medication transaction, user identity, timestamp, and quantity — all exportable for DEA audits.

Theft/Loss Reporting (21 CFR § 1301.74)

Immediate notification to DEA within one business day of discovering theft or significant loss.

MedixSafe Solution

Real-time alerts for discrepancies, missing inventory, or unauthorized access. Instant reporting tools with comprehensive documentation.

Access Controls (DEA Best Practices)

Limit access to controlled substances to authorized personnel only. Track who, when, and what.

MedixSafe Solution

Multi-factor authentication: PIN, card, fingerprint, or 2-person authentication. Role-based permissions and comprehensive access tracking.

Inventory Reconciliation (21 CFR § 1304.11)

Biennial inventory of all controlled substances. Maintain ongoing inventory records.

MedixSafe Solution

Automatic RFID inventory tracking every time the safe is opened. No manual counts, no discrepancies, instant reconciliation.

Diversion Prevention

Systems and procedures to prevent, detect, and investigate drug diversion.

MedixSafe Solution

Alerts and tamper monitoring — all designed to catch diversion before it becomes a crisis.

State-Specific Requirements Vary

While DEA regulations provide the federal baseline, each state adds its own requirements. Some states require:

Enhanced security for specific drug schedules
Real-time reporting to state prescription monitoring programs (PDMPs)
Biometric or 2-person access for high-risk medications
Specific audit trail formats and retention periods
Additional training and certification requirements

California

Title 22 requires automated dispensing systems in certain facilities
Enhanced security for fentanyl and high-risk opioids
Real-time CURES reporting for controlled substances

New York

I-STOP mandate for electronic prescribing
Stricter storage requirements for Schedule II drugs
Mandatory reporting to state PMP within 24 hours

Texas

Specific safe construction standards
Enhanced access controls for EMS agencies
State Board of Pharmacy audit requirements

Florida

E-FORCSE reporting requirements
Enhanced security for pain management facilities
Specific record retention and audit trail standards

MedixSafe has you covered

Discuss Your State Requirements

Access Controls

HIPAA requires unique user identification and emergency access procedures.

Individual PIN codes, badges, or biometric authentication. Emergency override with full audit logging.

Audit Controls

Hardware, software, and procedural mechanisms to record and examine access to ePHI.

Complete audit trail of every user access and medication movement — timestamped and immutable.

Data Integrity

ePHI must not be improperly altered or destroyed.

Encrypted data storage, tamper-proof logs, and automatic backup to secure cloud infrastructure.

Transmission Security

Technical security measures to guard against unauthorized access during electronic transmission.

End-to-end encryption for all cloud communications. TLS/SSL for web access. No unencrypted data transmission.

HIPAA Compliance is Built In

MedixSafe is designed with HIPAA compliance at its core. We don't just meet the technical requirements — we exceed them with enterprise-grade security, encryption, and audit capabilities.

Automatic Audit Trails

Every safe access, medication transaction, and system event is logged automatically with user, timestamp, and action.

Immutable, tamper-proof logs
Export in DEA-compliant formats
Search and filter by date, user, or medication

Expiration Alerts

Never miss an expired medication. Automatic alerts ensure you stay compliant and patient-safe.

Configurable alert thresholds
Email notifications
Works even when safe is offline

Inventory Reconciliation

RFID technology automatically tracks every medication, every time the safe closes.

No manual scanning required
Real-time inventory updates
Discrepancy alerts

Access Control Enforcement

User permissions ensure only authorized personnel can access controlled substances.

PIN, card, fingerprint, or 2-person authentication
Configurable access schedules
Emergency override with full audit

Built-In Compliance

Every MedixSafe narcotics safe is engineered with compliance at its core — from construction to access control to documentation.

Controlled access with user-level authentication

Tamper-resistant construction

Access attempts logged and stored

Interior and locking designed for DEA conformance

Compatible with shift-change reconciliation workflows

Reliable power + fail-secure locking

DEA-Ready Design

Built for regulatory compliance

Designed to meet controlled substance security requirements with tamper-evident construction and comprehensive audit capabilities.

100% Compliant

Access ControlPass

Audit LoggingPass

User AuthenticationPass

Tamper DetectionPass

Access Audit Log

Real-time activity tracking

Last 24 Hours

23 Events

Safe Access

John Medic

2 items

2 min ago

Remote Unlock

Sarah Chief

0 items

45 min ago

2-Person Authentication

Mike Paramedic + Supervisor

0 items

2 hr ago

Expiration Alert

System

1 item

3 hr ago

5 Months Faster

MedixSafe detects diversion on average 5 months faster than manual tracking systems

Why Narcotics Compliance is Complex

Federal DEA Requirements

State-Specific Regulations

Operational Challenges

Understanding Compliance Requirements

Secure Storage (21 CFR § 1301.75)

Complete Audit Trail (21 CFR § 1304.04)

Theft/Loss Reporting (21 CFR § 1301.74)

Access Controls (DEA Best Practices)

Inventory Reconciliation (21 CFR § 1304.11)

Diversion Prevention

State-Specific Requirements Vary

California

New York

Texas

Florida

MedixSafe has you covered

Access Controls

Audit Controls

Data Integrity

Transmission Security

HIPAA Compliance is Built In

Compliance Features That Run on Autopilot

Automatic Audit Trails

Expiration Alerts

Inventory Reconciliation

Access Control Enforcement

Built-In Compliance

DEA-Ready Design

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