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.
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.
In March of 2020, we knew so much less than we do now about COVID-19. One thing we did know, however, was that testing would be a critical element in fighting the pandemic. Testing sites were established around the globe, with unprecedented demand. It was completely predictable that the “bad guys” would look to profit by introducing counterfeit tests into the market. And they did. I wrote about it then: https://blog.systechone.com/blog/counterfeit-coronavirus-covid19-tests
Is a deadline an obligation or an opportunity? That’s something many pharmaceutical companies, particularly in the US, are considering right now as they look ahead to November 27, 2023. This is the date when the aggregation of serialized products into serialized cases and onto serialized pallets becomes mandatory in the US—along with the corresponding data that is captured and made available to all stakeholders.Serialization was introduced by the US Food and Drug Administration (FDA) as part of...
Do you wish the data across your pharma serialization lines was more accessible?
As someone who has worked in enterprise software for a long time, the “disconnected” nature of packaging line data is pretty incredible. Using Systech as an example, we may see network connectivity from enterprise systems to Level 3 Guardian, but rarely visibility to Level 2 Advisor and Level 1 Sentri.
Essentially, each line is its own island. We need to change that!
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.
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.
Indonesia is a country that is a collection of many islands in Southeast Asia. You may not think of Indonesia very often, but you should. Indonesia is the fourth largest country on Earth by population, behind China, India and the United States. It is the 14th largest by land area and the 7th largest when you consider land and water surface. It’s big, and it has been doing well economically for the last decade or so since the government stabilized. And they have a government-run universal health...
