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. Are There Business Benefits To Serialization Beyond Compliance? 6/18/2015

    This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence, 

  8. FDA And Industry Experts Offer Guidance For DQSA Preparation 3/3/2014

    It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.

  9. Three Questions To Consider For DQSA Readiness

    By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory

    Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.