The World Wide Web

The US drug supply chain regulation envisions a secure Electronic Drug Distribution system that requires authorized trading partners to access and interact with it. So, what exactly is this system and what are your responsibilities within it?

In simple terms, if you trade DSCSA impacted drugs, you need to exchange relevant product data and be electronically available to respond to specific requests. However, there is no single electronic method that fulfills all DSCSA needs. To determine your requirements, create a list of DSCSA regulated responsibilities and identify electronic interactions for related processes. For example, consider how you handle data error resolution or respond to requests from different channels.

It is important to choose your solutions wisely, considering scalability and the alignment with your specific needs. Before finalizing a solution, create procedures that define your organization's interaction with the electronic system for each circumstance, providing audit protection and clarity on interface requirements. By doing so, you can extract a set of comprehensive requirements, including security, speed, and control, to guide your decision-making process.

While solution providers offer solutions for specific circumstances, it's essential to choose logically and wisely to avoid an unwieldy collection of platforms that don't align with your SOPs and may not effectively connect with the communication channels of the World Wide Web (WWW). Remember, the WWW serves as the host for all communication channels, and selecting a Level 5 network provider that meets your needs will contribute to an efficient and secure drug supply system envisioned by the DSCSA. Prioritize making informed decisions to ensure the well-being of patients who rely on an effective and secure supply chain.