Regulated Substances

Course Program

Compliance need

format

Course Description

This training provides essential knowledge on the handling, security, and storage of regulated substances to ensure compliance with DEA, EPA, and other regulatory standards. Participants will learn best practices for safeguarding controlled substances, managing access, and preventing non-compliance risks.

Why Security and Proper Storage Matter:
Risks of theft, diversion, and misuse of controlled substances
Importance of compliance with DEA and EPA regulations to protect public health and organizational reputation
Regulatory Framework Overview:
DEA Title 21 CFR Part 1301: Minimum security standards for controlled substances
EPA Risk Management Program (RMP): Hazardous substances and threshold quantities
State and local laws that may impose additional requirements
Storage Requirements by Substance Schedule:
Schedule I & II: Locked, bolted safes or steel cabinets with double-lock systems
Schedule III-V: Locked drawers or cabinets meeting security standards
Refrigerated substances: Locked containers inside locked refrigerators
Physical Security Controls:
Anchoring safes and cabinets to walls or floors or ensuring they weigh over 750 lbs
Tamper-resistant locks and restricted access to authorized personnel only
Secure storage of usage logs to prevent identification
Access Control and Personnel Screening:
Screening and documentation of authorized users per 21 CFR 1301.90
Immediate revocation of access for unauthorized personnel
Regular monitoring and updating of access logs
Handling and Storage of Precursor Chemicals:
Separate storage from controlled substances
Compliance with chemical hazard storage protocols (flammables, corrosives)
Secure disposal and theft prevention measures
Case Study: UCLA Controlled Substances Storage Program:
Double-locked steel cabinets for Schedule I & II substances
Restricted access to minimize diversion risks
Regular audits and key control procedures for compliance
Consequences of Non-Compliance:
DEA fines, criminal charges, and loss of research licenses
Reputational damage and increased risk of public harm

Certifications Obtained Upon Completion

Certificate of Completion for Regulated Substances Handling and Storage Training

Regulatory Citations

DEA Title 21 CFR Part 1301: Security Requirements for Controlled Substances EPA Risk Management Program (RMP) Standards State and Local Controlled Substances Regulations

Additional Notes

This course is ideal for individuals handling controlled substances in research, healthcare, or industrial settings. Emphasis is placed on compliance, security best practices, and fostering a culture of safety and accountability.