Four serialization and traceability predictions

Careers can take unexpected twists. One twist led me to begin writing this column for Healthcare Packaging magazine, and another one is now taking me away.

This will be my last column. I have enjoyed working with the HCP management and staff over the last few years, and I will miss communicating with the readers.

For my last column, I decided to provide you with my personal predictions about pharmaceutical serialization and traceability over the next few years. Please do not count on these things happening. They are only predictions. See if you agree.

First, Brazil will delay their traceability requirement. Currently, Brazil expects drug companies to serialize and trace three lots by the end of this year. Then, by the end of next year, they expect all drugs to be serialized and traced.

The serialization part might be possible, but the way Brazil defines “traceability” is incredibly complex, and I predict will be too difficult for both the industry, and the government, to get working by the current deadline.

Second, India will delay their export traceability requirement. India recently made significant changes to their drug export serialization and traceability requirements, pushing them into the realm of being too complex for the expected deadline. I predict that either the deadline will need to be pushed out, or the requirements will need to be greatly reduced.

Third, the November 2017 drug serialization requirement of the U.S. Drug Supply Chain Security Act will not be delayed, but the FDA may invoke some enforcement discretion for a few months. This would be something like the FDA’s delay of enforcement of the Jan. 2015 requirements, which was delayed until May 1, 2015 to provide a time cushion for companies to get ready.

Of course, if the FDA takes this kind of action, they will not announce it until a few weeks before the deadline, so do not count on it.

And, finally, before Nov. 2023, companies in the U.S. pharmaceutical supply chain will band together to request a delay in the start of the full serialization-based requirements of the DSCSA, due to start in that month. This one is just based on the history of the industry reaction to these kinds of dates. It is a long way off, and a lot can happen between now and then, but remember my prediction.

Making predictions is hard. Not all predictions come to pass, and maybe none of these will