Constituent entities making up the United States drug supply chain – pharmaceutical manufacturers, whole sale distributors, dispensers and re-packagers – are extremely busy nowadays securing compliance with guidelines for transaction data exchange laid down in the recently passed Drug Supply Chain Security Act.
Things have not always been this way though. Before the DSCSA was proposed, the focus of the pharmaceutical industry was around getting the California-mandated serial numbers done on 50% of their packages, and that as well, latest by 1st January, 2015. The mandate, however, quickly evaporated by dint of federal preemption the very moment the Federal bill was signed into law. The result – a shift in focus from serialization to establishing mechanisms that track and trace on a lot-level Transaction Information (TI), Transaction History (TH) and Transactions Statements (TS).
While the May 01, 2015 deadline for enforcement of DSCSA by the FDA should be the prime concern for supply chain constituents, drug manufacturers and re-packagers need to pay special attention to serializing their drug packages and homogeneous cases. And that too, real soon. Why is that? Because the process is too intricate and the deadline (November 27, 2017 for manufacturers and 2018 for re-packagers) is not that far away either.
Regarding serialization, there exist a number of questions that need to be answered directly by the FDA. The first question is around the continuation of the usage of existing linear barcodes for serialization. To be more specific, the FDA needs to educate manufacturers and repackages on whether printing human readable lot number and expiration date as part of the new 2D barcode adequate as the sole information printed on the package or not? Deliberation is due by the FDA on what does and does not need to be printed on packages for streamlining the flow of the said thorough the drug supply chain resulted in improved operations, worker efficiency and stakeholder experience.
There is a spectrum of technical challenges that manufacturers and re-packagers are facing as they shortlist the optimal candidate serialization solution for themselves. Conventionally, while selecting a serialization solution, manufacturers and re-packagers get to choose only two from the set of three desirable features inherent to the solution – speed, reliability and requisite print quality.
Manufacturers and re-repackagers also need to choose how to handle serialization data management and any use of randomization. The DSCSA does not require serial randomization, however there are regulations elsewhere, like in Europe that require randomizatione. In this case, randomization is something to consider.
There are two types of ways for approaching randomization. The first is “randomness”, which is a way to choose the serial number where it is unpredictable. The second way is “sparseness”, which is a way where you have a long list of serial numbers and you are only allocating only using a fraction of the list. You can also use both, which make it more difficult for counterfeiters. Another property of randomization is “monotonically” or “non-monotonically”, monotonically is where an ascending successive serial number is always greater than the one that preceded it. In the end, which ever approach and property you choose will help towards the goal of securing your supply chain.
If companies chooses not to randomize, they run the risk of having someone in the supply chain to guess or estimate your manufacturing volume. This is done by looking at your serial numbers and sequentially seeing a pattern. If a pattern shows numbers 1,2,3, its obvious what comes next. Discovering a pattern, can allow a counterfeiter to put something in your supply chain by following your serial number sequence. By exploiting this, counterfeirs avoid discovery from being detected. One of the purposes of randomizing is to protect against anyone from detecting a pattern.
Some of the other challenges with serialization is considering the unique combinations of numbers and characters and length size. Imagine a serial number twenty characters in length. It is a pretty enormous number to manage for data entry and also consuming a lot of space on a bar code.
Consider also that serial numbers are treated just as a string of characters. The number “5” is not defined as an integer but a character. There is no difference between “5” or “05” these are two different serial numbers. What about uppercase vs lowercase letters? The same applies.
The biggest challenge moving forward for distributors and dispensers is having a system in place that can be open enough to interchange and manage this new data coming into your supply chain. Manual T3s will be gone, as lot level traceability will be “upgraded” to package level serialized data flowing into your supply chain.
Delivering all the three features together within a unified serialization solution might sure be difficult, but it is by no means impossible. At TrackTraceRx, we’ve painstakingly incorporating support for serialization in our state-of the-art, cloud-based server delivering on a serialization solution.
Feel free to drop us a line and discover how we can help you with serialization in particular, and DSCSA compliance in general. Again, no more than 3 to 4 working days and you’re up and running – the TrackTraceRx advantage on your side.