Progress Toward Serialization!?

2014 enough time graph.zoomLast week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz.  You should download a free copy of the report here.  This week I want to look at another interesting finding taken directly from the report.  It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market.  That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.

One of the many questions we asked the respondents from those organization was:

“What percentage of your total packaging lines are fully converted and ready to apply DSCSA-compliant package-level and case-level product identifiers?”

Here are the results:

2015.Percent PkgLn Done

As you can see, about 30% of the respondents indicated that between 25% and 49% of their total packaging lines are already fully converted and ready to apply DSCSA-compliant package-level and case-level product identifiers.  That’s not too bad.  I think those companies are well on their way toward meeting the deadline, assuming they continue making progress.  Ten percent of the respondents actually said that 100% of their lines are done.

Those who indicated the lower percentages might also be in good shape but the odds against that go up the lower the response.  For these companies to be on track, they would have to market only a small number of low volume prescription drug products and they would have to be well organized and intend to get aggressive about their line conversions from here on out.  If not, they could be at risk of missing that deadline.  The report is filled with revealing results and analysis like this.


One of the things some have predicted for years now is that drug manufacturers that have their own aging packaging lines might delay upgrading them, and then when they realized it was too late, they would make the decision to just switch their product(s) to a contract packager (CPO).  Of course, this would occur at the last minute, just before the 2017 (and 2018) deadline.

New white paper!
New white paper!

But that only works if CPOs have upgraded enough of their own lines in time to absorb the additional work.  This would probably require new packaging lines that would represent an expansion to their pre-serialization capacity.  That could be viewed as a little speculative, considering the history of pedigree laws being delayed in the US, so are these companies going to have the guts to make the necessary investments?  I hope so, for everyone’s sake.

If you are a manufacturer and your plan is to switch to a CPO for serialized packaging, or if you already make use of one or more CPOs to meet your current packaging needs, I suggest you lock down capacity commitments soon with your contract partner for 2017 and beyond.  This will help your CPO plan for the capacity they will need and, hopefully, give them time to get it deployed and tested in time for you and everyone else that takes this path.

Don’t forget to sign up for the remaining two free webinars in the series I am doing with Riya Cao of LSPediA.  Tomorrow we will take A Closer Look at Global Serialization and Aggregation, and in two weeks we will cover A Closer Look at Serial Number Randomization.  Register now for each one.  I hope to see you online.