Healthcare & Life Sciences Axway B2B Integration

Future-enabled controlled substance ordering helps achieve compliance and speed.

Future-enabled controlled substance ordering helps achieve compliance and speed.

Managing the distribution of controlled substances can be a technical headache for organizations throughout the pharma and healthcare supply chain, but it’s also an important responsibility that prevents diversion and abuse.

Federal fines of more than $300,000 recently levied against Yale’s Fertility Center highlight the risks of failure to comply with DEA requirements. Because of the exactness required by law, the surest way to securely – and cost-effectively – ensure compliance is by automating records processing with a modern electronic controlled substance ordering system (CSOS).

Understanding the Controlled Substances Act

The US Drug Enforcement Administration requires manufacturers, distributors, pharmacies, and other dispensers to collect, store, and submit documentation such as electronic order forms, certificates, and digital signatures in a predictable and secure manner.

Dive deeper into Controlled Substances Ordering System (CSOS) Modernization with this article in the Federal Register.

These organizations work hard to keep drugs on their shelves and meet critical patient needs, but in the case mentioned above, one nurse’s criminal actions weren’t stopped fast enough – in part because of noncompliant inventory processes.

The investigation found that the university failed to maintain proper records and couldn’t readily produce DEA e222 forms, which are required for the purchase and sale of Schedule II controlled substances.

Many CSOS solutions solve these problems partially, but they saddle companies with manual, paper-based workflows that consume resources and are prone to error. They also don’t integrate easily with partner systems, causing more administrative headaches.

Gain speed and agility with APIs

Because systems share a common language with APIs (Application Programming Interfaces), integrations can be completed faster and more cost-effectively and DEA e222 forms can be streamlined into your workflow.

APIs easily accommodate modifications in programs or connected applications, which means the ability to customize features like same-day delivery, real time transaction processing, and more is only a few clicks away.

API-enabled systems have emerged as a better way to streamline order processes and stay in compliance—now and in the future.

The Axway CSOS solution, for example, provides a more efficient, automated alternative based on an open API approach. By blending existing processes such as EDI with API technology, it gives you a more modern, API-enabled approach to achieving DEA regulatory compliance in a cost-effective, agile, and secure way.

Watch below to see how the modern, API-enabled modern controlled substance ordering system works.



Axway helped define electronic regulations for controlled substance ordering and has been a leader in the market, helping organizations move from paper to an API-based electronic system.

Manage digital relationships better

Axway’s solution allows pharmaceutical supply chain organizations to easily onboard partners while managing DEA certificates, encryption, and signatures — optimizing inventory management and drastically reducing delivery times.

Axway CSOS also provides real-time visibility and alerts to help you be more responsive to your partners and comply with DEA audit requests quickly and efficiently.

Using a modern REST-based API architecture and Single-Sign-On (SSO), the Axway CSOS Signing & Validation service enables integration to your existing customer portal for a seamless user experience.

Reduce costs with CSOS-as-a-Service

With a Software-as-a-Service (SaaS) approach to CSOS, Axway mobilizes a dedicated team of experts to run CSOS processes for customers who don’t have the expertise or resources to engage with the solution internally. It’s a more affordable subscription service that also cuts the costs of infrastructure investment.

One multinational healthcare distributor chose Axway’s controlled substance ordering system to manage the digital signatures required from customers for controlled substance transactions.

Whether you’re a pharmacy, dispenser, distributor, or manufacturer, you can rely on Axway CSOS to process any volume of CSOS orders dependably and reliability. Maintain compliance to avoid patient harm or severe penalties while scaling and integrating your CSOS initiatives to meet your business growth objectives.

Learn how to enable your CSOS processes for business growth.

Key Takeaways

  • Non-compliance with DEA controlled substance regulations can cause major fines or even shutdowns for drug manufacturers, distributors, and pharmacies.
  • Many controlled substance ordering systems (CSOS) don’t integrate easily with other systems and create manual, paper-based workflows.
  • Axway CSOS provides an API-enabled solution that automates and streamlines processes, integrates easily with other systems, and provides the right security to keep you in compliance.
  • Axway worked with the DEA in developing the e222 CSOS standard and is Drummond-Certified.
  • Axway delivers CSOS through a SaaS subscription that further drives down costs and reduces burdens on IT.