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...

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

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

More from Compliance

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.