We recently conducted a webinar entitled “Coming Down the DSCSA Stretch – Authorized Trading Partners, and What You Need to Know”. I was joined by Georg Jürgens, Manager of Industry Solutions at Spherity and Octavio Rodriguez Perez, Group Product Manager at Systech, for this discussion.
On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect. By that date, businesses at every level of the pharma supply chain—from manufacturers to dispensers—must implement an electronic, interoperable system to identify, trace and verify the prescription drug products they manufacture, package, distribute or sell in the US.
For pharmaceutical industry veterans, November 2023 marks the end of a decade-long journey to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.” This milestone will come with little fanfare, but with gigantic impact to the pharmaceutical supply chain.
Many major wholesalers are leading the charge for receiving aggregated data—requiring that manufacturers be able to digitally send pallet identifiers with corresponding digital details of all shipments sent to them. Without this data being aggregated, wholesale staff would have to open each pallet and manually scan each serialized product.
In an interview for the Vantage Solves Series I explained why November 27, 2023 is critical for the pharmaceutical supply chain. By this date members of the ecosystem must implement an electronic, interoperable system to identify and trace prescription drug products in the US to be compliant with the Drug Supply Chain Security Act (DSCSA). Additionally, wholesale distributors will require aggregation data to accept product in the coming year.
Preface: In this blog I’m going to assert that “the data associated with the drug and its supply chain transactions is just as important as the drug itself.” Disclaimer: The drug is certainly the most important part in the patient healthcare equation—data has nothing to do with that. BUT… there is a comprehensive data collection and integration reality that is required to get these drugs through the supply chain and eventually to the patients who need them. Ultimately, regulations like the...
Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time to analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down but is a growing threat.
Liquid Gold. That's how Interpol has described organized crime's view of vaccine demand. The more in demand a product is, the more it will be counterfeited. We can count on an absolute tidal wave of COVID vaccine and treatment counterfeiting to flood the markets now that the vaccine is available.
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain over 10 years ago. Major serialization mandates in the US, EU and other regions are now live. Now is a good time to reflect back on this massive undertaking and review some “lessons learned”. We say this because serialization isn’t “over” in pharma.
It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.