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Track and Trace in Pharma: Why it Matters

Pills and bottles - Track and Trace in PharmaceuticalsOn November 27, 2013, President Obama signed the Drug Quality and Security Act (or H.R. 3204) into law. Title II of the Act, known as the Drug Supply Chain Security Act, mandates that drug manufacturers will be required to create electronic tracking systems to ensure the legitimacy of pharmaceutical products introduced into the supply chain. Commonly known as “track and trace,” this system will be implemented in a phased approach over the next 10 years.

What is track and trace?  Simply put, the term refers to a collection of tools that help regulators and pharma companies determine the authenticity, identity, and location of a particular drug product.  The idea is to create a transparent pathway from manufacture to end user—where it has been and where is it going. 

Why is lot level traceability important?  To protect the end user.  There are too many examples of counterfeit products showing up in the US supply chain, creating vulnerabilities in the current system.  Track and trace would help eliminate these occurrences, ensuring safe and effective medicines for the end-user.

How does it work?  The concept is to serialize product, and require the downstream supply chain (manufacturers, repackagers, wholesale distributors, and dispensers) to only accept and distribute serialized product. This uniform standard is intended to replace the patchwork set of state laws that now govern the process.

Having a standardized set of procedures to rely on, and requiring manufacturers to provide electronic transaction information and supply chain history, can only lead to safer products for consumers.  This is a great start, and should help pave the way for even safer supply chain practices in the future.

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Johnny Richards

Johnny Richards

Project Manager at BioConvergence LLC
Johnny's 17-year career in contract pharmaceuticals includes 6 years at Cook Imaging/Pharmaceutical Solutions LLC, and 10+ years at Baxter Pharmaceutical Solutions. Job titles have included Senior Logistics Analyst, Shift Superintendent, Supervisor of Logistics and Warehousing, and Business Development Associate. Johnny has a BA in Liberal Arts from Indiana University.
Johnny Richards

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