DSCSA Pilot Used Blockchain To Trace Drug Through 'Last Mile' of Supply Chain

A blockchain application for mobile devices was successfully piloted to conduct real-time tracking of a high-cost drug through the “last mile” of the supply chain to the point of dispensing. Such a tool can be useful for manufacturers in tracing their products through the supply chain and complying with a forthcoming mandate of the US FDA Drug Supply Chain Security Act (DSCSA).

QR code scanning payment and verification. Hand using mobile smart phone scan QR code
Blockchain Technology Uses Mobile Application To Convey Information On Drug's Authenticity • Source: Shutterstock

A blockchain system that uses a mobile device to transmit information on changes in drug custody has enabled Biogen, Inc. to track and trace the company's high-volume, high-cost Spinraza (nusinersen) through the proverbial last mile of the pharmaceutical distribution chain at UCLA Health, demonstrating that the system can be used by manufacturers to comply with a mandate of the US Food and Drug Administration’s Drug Supply Chain Security Act that requires data architecture systems to be in place by November 2023.

So asserted Ben Taylor the CEO of LedgerDomain, who spoke at a 24 July webinar on implementation of the Drug Supply Chain Security Act (DSCSA) sponsored by the Partnership for DSCSA Governance (PDG), a group that is looking to advance the goals of the law’s implementation. PDG was formed last year as a non-profit coalition that is helping to guide and coordinate the data architecture system that participants in the biopharma distribution chain should have in place to communicate with each other under DSCSA to prevent drug counterfeiting

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Manufacturing

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

More from Compliance