Building a better supply chain
Taking stock of lessons learned during pandemic—and opportunities to grow stronger
With the worst of the Covid-19 pandemic behind us in the US, as more Americans get vaccinated, mask and social-distancing measures are lifted and the public settles back into relatively normal life and work routines—contrasted with the devastation still unfolding in India as it deals with Covid’s second surge—there may not be a better time than the present to explore the theme of supply chain disruption in the pharma industry.
We do exactly that in the June issue of Pharmaceutical Commerce. If not to learn about the hard but valuable lessons manufacturers and their suppliers gained while navigating the pandemic, and new strategies in digitalization and risk monitoring employed as a result, then to hear insights on how the global community can best prepare and mobilize for future threats in areas such as drug serialization and track and trace.
And, as we examine this month as well, advances in those fields and the larger pharma distribution picture will go only as far as compliance to and understanding of changes in supply chain regulations. Take, for example, the Drug Supply Chain Security Act (DSCSA), originally passed in 2013. As we report here in news on recent FDA-issued guidances, the agency has delayed enforcements of several new DSCSA mandates until 2023. One of those is the requirement of pharma products to be serialized and labeled to support an interoperable, electronic system for identifying and tracing medicines throughout their journey in the US.
This kind of standardized system, the thought is, will enable better data sharing and thus improve supply chain efficiencies and patient safety. As our coverage illustrates, the industry is making progress in achieving full DSCSA implementation—on the company level and collaboratively, assessing barcoding capabilities and potential synergies with technologies such as RFID.
The takeaway message is clear: the need for transparency and visibility across the supply chain is critical. That’s what these regulations are trying to ensure. And that’s the focus of optimization pursuits on the industry side. The end goal is the same—getting medicines safely to patients uninterrupted. Thank you for reading.
— Mike Hennessy Sr. is the founder and chairman of MJH Life Sciences.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
