DSCSA Compliance
What you need to know today

In 2013, the United States Congress enacted the Drug Supply Chain Security Act (DSCSA), putting in place requirements and a timeline to develop and enhance drug supply chain security. With the DSCSA stabilization period currently extended, now is the time to ensure readiness for your pharmaceutical supply chain. 

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DSCSA Compliance : Top 3 reasons for distributor preparedness

Ensuring Safe and Legitimate Products

Health systems rely heavily on distributors, along with wholesalers and third-party vendors, to implement strong compliance plans. Distributors play a key role in guaranteeing that the products they handle meet all safety and legitimacy standards as per DSCSA requirements.

Maintaining Customer Trust

Building and maintaining trust with customers is paramount for distributors. Non-compliance or inadequate preparation for DSCSA regulations could significantly damage the trust that has been established or is growing with your clients. Demonstrating rigorous compliance efforts assures your customers of your commitment to safety and reliability.

Regulatory Accountability

Regulatory bodies are now heightening their oversight and auditing activities. Distributors could face inspections and will be held accountable for meeting all DSCSA compliance requirements. Ensuring your team and product lines are fully compliant is vital to avoid potential audits, penalties, or operational disruptions.

The Distributor’s DSCSA
Compliance Solution Checklist

Distributors looking to overcome DSCSA compliance challenges will take more than a wait-and-see approach; finding a strategic partner and platform is crucial.
Healthcare distributors should look for:

DSCSA Expertise

Partners play an important role in complying with DSCSA requirements. They are the keepers of the data repositories, which means they are the middleman in any transactions within the healthcare supply chain. Look for a strategic partner with proven DSCSA expertise.

Integrated DSCSA Compliance

The need for duplicate processes can be eliminated by using a warehouse management system (WMS) with a seamless DSCSA component rather than an add-on.

Comprehensive System Features

The WMS should be designed for DSCSA compliance, including agility, adaptability, scalability, efficiency, interoperability and personalization. It should also feature systematic multi-level serialization inference and systematic enforcement of all DSCSA rules and mandated, real-time event posting.

Start Your Journey Toward True DSCSA Compliance

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As the market leader in healthcare supply chain solutions, Tecsys Elite™ WMS for healthcare distribution is designed to address the needs of high-cost-of-failure supply chains, specifically in the pharmaceutical and healthcare setting.

  • Built-in DSCSA serialization compliance
  • No dual entry 
  • Out-of-the-box compliance
  • One single system vs multiple systems

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