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

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.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

More from Compliance

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By 

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By 

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.