A modern, API-led approach to compliance with U.S. DEA regulations
The U.S. Drug Enforcement Agency (DEA) requires all controlled substances to be bought and sold only by approved entities. To ensure approval, pharmaceutical manufacturers, distributors, dispensers, and pharmacies must submit a Form 222 or its electronic equivalent, Form e222. File-based Controlled Substance Ordering System solutions enable electronic submissions, but these legacy systems don’t offer the agility to handle future processes or compliance demands.
Unlike legacy, file-based solutions, Axway Controlled Substance Ordering System (CSOS) uses an open API approach to DEA compliance that provides the business flexibility, security, and speed to adapt to evolving use cases and regulations.
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WHO NEEDS TO SEE THIS?
• VP/Directors of Technology
• Compliance Officers
• Order Flow Managers
• Warehousing Managers
• Lead Pharmacists
WHO WANT TO...
• Move from inefficient paper-based DEA 222 Forms to electronic 222 Forms
• Meet current and future needs with business agility
• Speed onboarding processes
• Streamline the customer’s ordering experience
• Always pass DEA audits
• Add new revenue streams
• Rely on slow and costly manual processes
• Can’t ensure cross-site visibility and cooperation
• Have an outdated UI and disjointed customer experience
• Risk penalties for noncompliance with DEA regulations
• Aren’t prepared for future customer demands
Then it’s time to modernize with Axway’s API-enabled CSOS solution.
The pillars of Axway CSOS based on Controlled Substance Ordering System use case requirements
DIGITAL FORM E222 CREATION
Take the manual effort out of controlled substance ordering by processing electronic e222 controlled substance orders in real-time with full DEA compliance.
SECURE CERTIFICATE VAULT
As users register on the system, certificates are uploaded to the secure vault through an integrated customer portal that gives users a familiar interface with seamless interaction.
CERTIFICATE AND PASSWORD VERIFICATION
Certificates are cross-referenced against the control revocation list published by the DEA. This prevents any inactive certificates from being used in the signing process. Valid certificates are signed using a password known only to the certificate owner.
Axway CSOS solution advantages
Innovation in healthcare technology demanded a change from a strictly on-premises solution to a cloud-based solution using API technology. An open API approach to CSOS allows a common language to be shared across the platform, making integrations faster, more cost-effective, and readily upgradable.
OPEN API STRATEGY
Gain business agility and speed to meet current and future demands by leveraging a modern open API approach for CSOS processing. What used to take months to develop an API can now be done in weeks with off-the-shelf functionality.
SIMPLIFIED INTEGRATION AND CERTIFICATE MANAGEMENT
With the built-in certificate vault and modern integration techniques, Axway provides a true enterprise solution for online CSOS ordering portals without complex authentication challenges or redirects.
USE CASE FLEXIBILITY
Implement a broad solution for use cases including processing DEA Form e222, license verification, certificate revocation, and certificate management. The Axway CSOS solution offers a robust back-end of extensible technology enabling customers to monetize new revenue streams such as immediate transaction processing and same day delivery.
SWIFT FORM RETRIEVAL
Axway CSOS solution provides digital storage and retrieval of the forms for 2 years, as mandated by DEA — a more secure and accessible way compared to paper based processes.
Axway worked with the DEA as an advisor in developing the e222 CSOS standard and is fully accredited as a Drummond-certified CSOS application.
Whether you are a pharmacy, dispenser, distributor, or manufacturer, you can rely on scalable, cutting-edge Axway CSOS solution to process any volume of CSOS orders dependably and reliably.
CSOS CENTRAL SIGNING
Very large organizations that have central signing authority may also be interested in our central signing capability.
Healthcare companies succeeding with Axway CSOS
Pharmacies, manufacturers, distributors, and dispensers can reach their current and future objectives for DEA compliance and business growth with Axway CSOS.
A self-service portal to place and track orders
The DEA requires pharmaceutical and medical product distributor, Cardinal Health, to get digital signatures when ordering controlled substances. The company uses API-driven CSOS cloud services from Axway to ensure compliance and aims to build on its relationship to create new solutions and improve healthcare.
- 220K pharmaceutical orders processed every day
- 50% of annual revenue passes though self-service portal
- 330K internal transactions processed daily
Scalable, 24/7 communication with trading partners
Pharmaceutical distributor, AmerisourceBergen, uses Axway B2B Integration to create a scalable digital front door that ensures always-on communication with trading partners — especially during peak activity. The company now rapidly identifies resolves EDI issues to meet demanding SLAs and optimize CSOS across 1,500 locations.
Ready to future enable your CSOS processes for business growth?
Contact us to learn more about Axway CSOS.