CSOS e222 Forms: Electronic Recordkeeping for Controlled Substance Orders

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For additional resources to support pharmacy controlled substance ordering and inventory compliance click HERE.  

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The Controlled Substance Ordering System (CSOS) allows pharmacies to electronically order Schedule II controlled substances using e222 forms. While this system improves efficiency, it also comes with strict recordkeeping requirements that must be followed to remain compliant. 

Improper management of CSOS records can lead to significant penalties—DEA fines may reach up to $19,000 per violation, which can quickly escalate if multiple records are incomplete or missing. 

Required CSOS e222 Recordkeeping Elements 

Under federal regulations (21 CFR 1311.60), every CSOS order must include a complete and accurate electronic record of receipt. 

Each e222 record must include: 

• A status update marking the order as “received”  
• The date the order was received  
• The name of the individual who received or reviewed the order  

These elements confirm that the order was properly received and verified, forming a critical part of controlled substance accountability. 

Record Storage & Accessibility Requirements 

CSOS records must meet the following standards: 

• Electronically linked to the original order  
• Maintained in electronic format (not solely printed copies)  
• Readily retrievable for inspection  
• Retained for a minimum of 2 years (or longer if required by state law)  

Failure to meet any of these requirements may result in compliance violations. 

Best Practices for Staying Compliant 

Implementing consistent workflows can help ensure CSOS records are complete and audit-ready. 

• Update Orders Promptly 
  Access each e222 form as soon as the product is received and promptly mark it as “received” according to your wholesaler’s process  
• Download & Store Records 
  Save completed e222 forms in a secure location, such as:  
  • A cloud-based system  
  • A protected local drive  
• Use Standard File Naming 
  Create a consistent naming convention (e.g., date + supplier + order number) to make files easy to locate  
• Conduct Routine Reviews 
  Periodically review all CSOS orders to confirm:  
  • Receipt status is updated  
  • Required details are complete  
  • Files are properly saved and accessible  
• Maintain Organized Systems 
  Keep folders structured and easy to navigate to support audits and inspections  

Proper management of CSOS e222 records is essential for maintaining compliance, ensuring traceability of controlled substance orders, and avoiding costly penalties. By establishing clear processes and routinely verifying records, pharmacies can stay organized, audit-ready, and fully aligned with regulatory expectations. 

Disclaimer: These tools and templates are intended for general informational purposes and are provided by Montana Family Pharmacies as a service to pharmacies. While we try to keep the information timely and accurate, we make no guarantees. These tools and templates are not a substitute for legal, regulatory, or professional advice. 

Policies and procedure, templates, checklists, and other tools should be customized to fit the specific needs and regulatory requirements of your pharmacy. 

Montana Family Pharmacies disclaims any liability for any damages, losses, or other consequences arising from the use or reliance on the tools or policy templates.