Serialization and the Drug Supply Chain Security Act
Find out more about Serialization and the Drug Supply Chain Security Act. First off, what is Serialization ? Serialization is a requirement of the Drug Supply Chain Security Act (DSCSA), a law enacted to detect and prevent the distribution of counterfeit, misbranded or diverted prescription pharmaceutical products in the supply chain. Starting on November 27, 2017, all pharmaceutical products are required to carry a unique barcode or RFID that identifies the product as well as unit-level identifier at each salable unit distributed into interstate commerce. (See illustration below.) The FDA has granted a one-time, one-year extension on enforcement of the due date to November 27, 2018.
A number of other requirements are promulgated in Drug Supply Chain Security Act, including requirements for certification of wholesalers and 3rd-party logistics providers, requirements to provide information certifying the authenticity of the product at every change of product ownership, scanning the label upon receipt, and investigation requirements whenever suspect product is identified.
CTI’s Service Offering
CTI offers a complete Program Management solution to establish a process at pharmaceutical companies to achieve serialization compliance. We call our solution “Track and Trace: Tried and Tested.” T&TT&T is based on the four major cornerstones of building a DSCSA-compliant system: Technology (i.e. IT and packaging systems) Business Partnerships (with distribution chain vendors and solutions vendors) Compliance (with the Act, Quality Systems, and Validation) and Program Management, which puts all these systems together.
What Does Drug Supply Chain Security Act Mean for Pharmaceutical Companies?
The Drug Supply Chain Security Act will require a lot of work to be completed at pharmaceutical companies that manufacture prescription medications that move through the supply chain. Manufacturers need to create a systems and packaging that facilitate barcode for tracking each unit introduced into interstate commerce. The barcode information will be transferred to the FDA’s interoperable system so all transactions involving prescription drugs can be authenticated upon receipt, by scanning the barcodes and/or RFIDs.
To perform these activities correctly, new quality management systems need to be created, with new procedures and corresponding training. Validation needs to take place to ensure that the serialization solution is working as specified, including validation of the equipment itself for the serialization solution, as well as the software for creating, tracking, archiving, sending and authenticating the identifiers. Furthermore, serialization has a significant supplier quality component, where suppliers supporting the serialization software and hardware solution require vendor clearance. Supplier qualification will also be necessary for distribution partners down the supply chain, to ensure that they, too, have the appropriate quality procedures and processes in place to support Serialization and the Drug Supply Chain Security Act requirements.
The good news to pharmaceutical companies is that Compliance Team has the expertise in quality systems, validation, and supply chain management to help relieve the pressure on organizations who are working to achieve Serialization and the Drug Supply Chain Security Act compliance. Our experts have operated in this space and can help to make your company serialization ready so you can pass your next DSCSA-centric audit.
Keeping Abreast of Changing Requirements
Serialization requirements are always changing. The FDA plans for full implementation of all aspects of the law in 2024, and the FDA has yet to identify how all of the law’s requirements will be enforced (or even fulfilled). Furthermore, other countries are jumping on the serialization bandwagon, each with separate requirements aimed at achieving goals that may or may not align with DSCSA’s goal of ensuring that only authentic products reach the end-user. Needless to say, serialization has a lot of parts that are constantly in flux. If your company markets pharmaceutical products in multiple countries, it may take time to figure out how to build a flexible system that can meet both FDA requirements and the requirements for other targeted countries.
Additional Business Benefit
Serialization can be complex and costly to implement. However, having an understanding of your product’s path in the supply chain can create opportunities business value. Such business value may even be able to the serialization startup expense. Compliance Team can help identify these business opportunities so you can include these items in your system requirements. In essence, CTI’s T&TT&T solution may pay for itself!
What to Do if Overwhelmed
Begin with the end in mind. Get extremely focused on your objectives, which should be (in no particular order):
- Compliance with the Act
- Establishment of System at Best Cost
- Leverage System to Drive Business Value
- Achieve Supply Chain Security
- Ensure Patient Safety
- On-Time Project Delivery
Serialization is a big project, with enormous compliance impact. If you are drowning from the flood of information and work coming your way, it is time to call Compliance Team. We are there to help you implement serialization so it meets your specific needs, and we are more than willing to help you manage the workload, be it with project management, validation, quality system implementation, supplier quality engineering, or general boots-on-the ground help. Let Compliance Team become part of your serialization team.
Have a Serialization or Drug Supply Chain Security Question or interested in our Serialization Services?
Fill out the form below to ask your question or learn more about CTI can help you become DSCSA ready.