Navigating the Evolving Landscape of DSCSA Tracing: Insights from Industry Experts
Understanding Tracing Basics:
Tracing, a fundamental process under the DSCSA.Despite being confined to the expertise circle of DSCSA professionals, Tracing is poised to become standard practice in the pharmaceutical industry once the DSCSA requirements come into full effect.
Digging into DSCSA Tracing Requirements:
Exploring SEC. 203 of the Drug Supply Chain Security Act, under Enhanced Drug Distribution Security, sections 582 (D) and (E) outline two distinct Tracing requirements.
- Section 582 (D):
- Mandates prompt responses from all trading partners during a suspect drug investigation or recall initiated by the FDA or another agency. This involves providing transaction information, including serial numbers, in response to agency requests.
- Section 582 (E):
- Requires the establishment of systems to facilitate the gathering of transaction information, specifically tracing back to the manufacturer. The responsibility for gathering data during investigations remains a point of debate since the enactment of DSCSA in 2013.
Transitioning to Practical Implementation:
As the industry gears up for the November 27, 2023, milestone when serialization data becomes more prevalent in the supply chain, practical implementation of Tracing processes is a subject of ongoing evolution.
Integration with Suspect Product SOPs:
Insights from roundtable sessions underscore that tracing is an extension of existing suspect drug investigation procedures. The tracing request, rather than being viewed in isolation, should be considered a crucial component of a robust suspect drug investigation.
Practical Considerations and Industry Practices:
As of the latest update, the industry is grappling with the manual handling of tracing requests. While major wholesalers predominantly resort to email communication for sending and responding to tracing requests, there is a hesitancy to automate responses, especially in suspect drug investigations, to ensure human review for accuracy and accountability.
Challenges and Questions:
Addressing challenges, the industry contemplates the sustainability and security of email-based tracing requests, particularly in the face of increasing investigative activities. Questions about the FDA’s envisioned system for tracing requests and the role of credentialing in ensuring secure data exchange remain open.
Anticipating Future Developments:
As the industry anticipates more tracing requests, particularly from federal and state agencies familiarizing themselves with DSCSA, companies are urged to reevaluate suspect product investigation SOPs. The evolving processes and industry best practices for facilitating tracing requests are expected to continue evolving, shaped by the dynamic landscape post-November 27, 2023.
Conclusion:
The call to action involves a comprehensive review of current SOPs, readiness to handle tracing requests from diverse sources, and the ability to respond within stringent timelines. The processes and industry best practices for facilitating a tracing request will undoubtedly evolve, presenting an ongoing challenge and opportunity for industry stakeholders.
