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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...

When you start a company, your goal is to create a popular and profitable product. You are decidedly not thinking about the fact that your product will get counterfeited and sent to the gray market when it does get popular. And trust me, that will happen.When I met with the American skincare brand OZNaturals® they were riding the wave of rapid growth and impressive success. The company was launched in 2013 by CEO Angela Irish with the goal of creating a range of clean, efficacious, and...

It’s almost peak holiday shopping season and consumers are once again on the lookout for that perfect gift. However, this year is unlike any other with the events of the last 18-months putting stress on supply chains around the world.

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.

Crowdsourcing your counterfeit detection gives you an army of real-time field inspectors. The underlying tech is also your key to more connected customers.

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. 

Crime has no moral code. If you have a high-demand product, people will likely counterfeit it. Itcomes as no surprise that during this time of pandemic, counterfeiters are targeting everythingfrom hand sanitizer to test kits. (In 2020 I blogged about counterfeit COVID test kits and counterfeit COVID vaccines.)