UPDATE 5/29/2018 – The FDA has extended the deadline for serialization compliance to November 26, 2018. Even if serialization isn’t completely implemented by this date, the FDA is likely to give leeway to those who can show that they have the necessary equipment on order and can provide a date for startup.
Contact us today to order your equipment to ensure you meet the FDA serialization requirements as soon as possible.
November might seem a long way off, but the challenge for US companies to meet new serialization compliance deadlines for pharmaceuticals is just around the corner. And people’s lives depend on it.
Furthermore, experts in the industry warn that if companies don’t have the executive-level commitment that will ensure they are compliant, they will be “doomed.”
Mandatory requirements are detailed in the 2015 Drug Supply Chain Security Act (DSCSA).
Global Serialization for Pharma
By 2018 most global drug supply companies will be forced to comply with serialization of some sort. But even though serialization is going to be a standard requirement worldwide, requirements for different countries will not be the same. This means that US companies exporting to other countries will face additional challenges. This will also be a challenge for those operating packaging equipment and packaging machinery.
Nevertheless, when serialization becomes a reality, supply chain companies are going to have to be able to produce the required documentation for dispensed drugs within 24 hours. This means that businesses operating in the industry will need to have good, reliable storage and retrieval mechanisms that support the verification process.
US Serialization for Pharma
The US requirements to meet “track and trace” regulations in the pharmaceutical industry started in 2015 and will continue to be implemented until 2023. Specific challenges for supply chain companies vary, but right now the looming 2017 deadline is paramount.
In 2015 lot-level traceability was mandated. Now the issue is full drug serialization. By November 2017, all US drug supply chains must – by law – serialize. It’s that simple.
By November 2017 all pharma manufacturers must include a product identifier on packages. They must also include a serial number, as well as a lot number, and an expiration date.
Those companies that don’t have access to reliable packaging machinery and packaging equipment that can cope with these needs will be in big trouble.
US Lives Depend on Drug Companies’ Compliance
Project management professional, Steve Peterson from Peterson Group is an expert in serialization, and he helps pharmaceutical companies to develop strategies that will enable them to meet the deadlines that relate to serialization.
Dedicated to helping companies meet the deadline, he provides a very personal motivation. Because he suffers from aplastic anemia – a condition that results in the body producing insufficient new blood cells – he needs medication that must be serialized. If it isn’t, it could impact negatively on his health.
Peterson also maintains that if companies don’t commit at top management level to achieving DSCSA serialization compliance they are “doomed.” Simply, if top management underestimates the resources required to meet serialization deadlines in November 2017 they might just fail.
“Mergers and acquisitions can lead to artwork revisions. Companies might want to consider label consistency to reduce excess changes,” he said.
Packaging is key! And according to packaging experts, it takes about 34 weeks from the planning phase to implementation of serialization. Training is also essential and aggregation will take at least 12 months – which means many companies are running out (or have already run out) of time.
So if you need packaging machinery or any type of packaging equipment to help you meet the November 2017 serialization deadline for pharmaceuticals, call Technik right now. We can help!