Featured Pharma Online Editorial

  1. 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement 1/6/2021

    This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

  2. Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? 10/5/2020

    The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.

  3. Merck, Walmart, IBM, & KPMG's FDA Blockchain Pilot: What We Learned 6/17/2020

    IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S. 

  4. DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand? 5/27/2020

    As the requirements for serialization and track & trace become more challenging to implement as we approach 2023, blockchain, by providing data integrity throughout the supply chain, becomes a more attractive solution to reducing the probability of errors occurring.

  5. Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points 4/13/2020

    With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.

  6. Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes” 3/16/2020

    During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?

  7. Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace 8/19/2019

    From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

  8. Next Steps For Serialization In The Pharma Supply Chain 7/22/2019

    The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.

  9. DSCSA's 2023 Interoperability Requirements: Don't Just Check The Compliance Box 6/27/2019

    The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?

  10. FDA's First DSCSA Warning Letter — A Closer Look 3/11/2019

    The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.