How banding can help you comply with the new track & trace regulations
Counterfeit. Stolen. Contaminated. These are all valid, and unfortunately all too real, threats to the prescription drug supply chain. But, the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA), outlines requirements to help keep the prescription drug supply chain one of the safest in the world.
Enacted by Congress in 2013, the DSCSA’s primary concern is building “an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” A series of laws and policies have been, and will continue to be, put in place in 3 phases:
PHASE 1: LOT-BASED TRACEABILITY AND VERIFICATION
In place since 2015, this phase requires manufacturers, wholesalers, re-packagers and pharmacies to track any changes in batch ownership. In other words, any time a batch reaches a new destination in the supply chain, it must be recorded.
PHASE 2: UNIQUE SERIALIZATION
Beginning in 2017, this phase requires single packages rather than larger batches to be marked with serial numbers and bar codes. So, whether it be an individual product or multi-pack, each saleable package unit must be marked with the appropriate variable data to track throughout the supply chain.
PHASE 3: UNIT-LEVEL TRACEABILITY
The most advanced tracking requirements will be put in place in 2023. Phase 3 will require information to be provided to supply chain partners to trace each individual unit back to the original manufacturer or re-packager. In addition to providing the most robust safety measures possible, once this phase is complete, any recalled product will be traceable back to their original source so as to more effectively control the products that should be, and are, recalled.
Ultimately, the goal is to develop “a database where uniquely identifying bar codes on drug packaging can be verified at point of dispensing [to] … significantly improve the ability to track pharmaceutical products on a global basis.”
HOW CAN BANDING HELP?
Banding is an elite form of bundling with models specifically designed for track and trace, making it easy to comply with the DSCSA’s new regulations. Here are just a few of the many benefits of banding:
To aid in track and trace, tamper-proof and tamper-evident materials should be used on every product. With fully-adjustable tension, products can be held together securely. With tandem banders or cross-bands, each bundle can be tamper-proof or tamper-evident and protected against counterfeit and stolen drugs.
Should worker safety be a primary goal, we offer perforated material that can be safely removed from any side of the product without tools. But don’t worry, the perforated banding material can still accommodate fully-adjustable tension and will be as strong as needed for your application.
Enhancing a banding system with an inline printer not only helps improve productivity by combining bundling and tracking into one step but also aids in anti-counterfeiting and traceability.
By imprinting variable data (barcodes, serial numbers, lot numbers) on each band, batches will be appropriately marked, making it difficult for counterfeit drugs to be swapped in and out throughout the supply chain.
Not only that but in the event of a recall, banding makes it easy to identify products based on location or manufacture date.
Interested in learning more about how banding can help you comply with the new track and trace regulations? Give us a call! Our healthcare packaging specialists will be happy to help you.