Serialization is Only the First Step

Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019.  If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.

Thus, the significant interest in best practices to get serialization implemented as efficiently as possible.  We have done numerous blogs and a podcast on the basics of serialization and best practices of implementing serialization solutions.

In our Feb2018 podcast, we have a slightly different take on the situation.  Serialization goes live in the USA and in the EU in less than a year.  Projects will be finishing up.  What happens after serialization is a “go”?  The answer is that there are many moving pieces still to manage and get ready for.

Systech’s Regulatory Strategist Dirk Rodgers was asked to walk through the “what’s next” after the first step of serialization is accomplished.  There is a lot of interesting information here that covers both the USA DSCSA and EU FMD post go-live reality.

Here are some high level thoughts and excerpts that the podcast delves into:

“In the next 12 months, we will pass the deadlines for both enforcement of the serialization requirement of the US DSCSA and the EU FMD.  Can drug manufacturers relax once they meet those requirements?”

For the US, companies need to

  • Start responding to requests to verify drugs at the serial number level (this is new as soon as enforcement of the serialization requirement begins). DSCSA ‘Verification’ should not be confused with ‘barcode verification’, a distinctly different process;
  • retain records of serial number application to their drugs for six years, and be prepared to respond to requests for information to support investigations by state and federal agencies;
  • continue sending the same transaction documents (TI, TH, TS) to their customers, as they have been since 2015

For the FMD, companies need to

  • Transmit information about every drug Unique Identifier to the EH Hub before they enter the supply chain
  • Update the EU Hub anytime drugs are destroyed, stolen or otherwise exit the supply chain when the manufacturer is a party

“We often hear about aggregation being necessary, can you put it into context for us?”

  • Aggregation data capture and sharing is not a stated regulatory requirement, but is a business requirement in the US and may become one in the EU
  • In the US, wholesale distributors are asking for data obtained from aggregation data capture as part of fulfilling their DSCSA 2019 saleable returns verification requirement.  An alternative to aggregation data capture is for drug manufacturers to connect to the future HDA Verification Router Service.
  • In the EU, some of the Unique Identifier decommissioning requirements can only be implemented successfully if drug manufacturers capture aggregation data, so it is an unstated, or indirect requirement.  For example, if a truckload of drugs is hijacked when enroute to a wholesale distributor, all of the unique identifiers must be updated in the EU Hub to indicate that they were stolen.  About the only way that can be done is to capture aggregation data for all unique identifiers.  You just can’t predict which ones are going to be needed for something like that in the future.

“The FMD will be fully effective next February, but the DSCSA has more deadlines coming up in the future.  What should drug manufacturers, CMOs and 3PLs be preparing for next?”

  • I’ve already mentioned the need to help the wholesale distributors with their DSCSA saleable returns verification requirement in 2019
  • Beyond that, the next major milestone for those companies would be 2023.  The problem is, no one knows yet what the exact requirements are going to be.  Companies need to either participate in FDA activities aimed at defining those requirements, or pay close attention to the outcome of those activities.  At Systech, we are actively participating so that our solutions will meet the needs of our customers, now and in 2023 when things change.