Drug Supply Chain Security Act (DSCSA) Mandate
What you need to know?
On November 27, 2013, Congress enacted the Drug Quality and Security Act (DQSA), which includes the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines steps to build an electronic system to identify, track and trace certain prescription drugs as they are distributed in the United States. This legislation was enacted in order to transform the pharmaceutical supply chain through serialization and improve patient safety.
Manufacturers, wholesalers, re-packagers and pharmacies have been required to implement lot-level management since 2015. Starting in November 2017, phase II of the DSCSA implementation requires manufacturers and re-packagers to serialize packages of drug products using a GS1 product identifier (either GTIN or NDC), serial number, lot number and expiration date, and embed this information into a 2D Datamatrix barcode. In November 2019, wholesalers must accept only serialized products and must verify unique product identifiers. By November 2020, pharmacists must meet the same requirements. Lastly, by November 2023, all information will be required to be made available that would allow supply chain partners to trace the ownership back to the initial manufacturer or re-packager.
What does a DSCSA solution do?
Our DSCSA hardware and software solution is focused on developing a traceability solution that incorporates transaction management, repository of historical snapshots of data for retrieval, and detects exceptions and provides easy to use visibility to traceability data in a matter of seconds.
What are the benefits of DSCSA?
Besides being in compliance, patients and supply chain companies are able to take advantage of the benefits of DSCSA, such as:
- Improved patient safety and care
- Compliance with serialization requirements helps move the industry ahead with better traceability and accountability for the origin, chain of custody, delivery, and availability of authentic, original prescription drugs
- Improved accessibility to patients for the drugs they need and assurance that they are exactly the drugs prescribed by their physicians
- Reduction of counterfeit drugs by having serialized identifiers
- Maintaining profits for the industry providers against counterfeit products
- Enables quick and accurate recalls of drugs, if needed
- Increased efficiency throughout the supply chain by optimizing inventory tracking through serialization
What do I need to be in compliance?
Converting manufacturing lines from lot-based to unit-based serialization represents an investment in software and hardware. Barcode scanners and barcode label printers are a necessity to print and scan a GS1 2D Datamatrix barcode label. Wireless networking is an option for manufacturers looking to future-proof their operations. While all facilities present different challenges, service providers like Barcodes, Inc. can provide a consultation to ensure all the technology is identified and implemented in accordance to compliance regulations.
While the deadline remains the same, the FDA has issued a one year reprieve, meaning that the agency will not take action against manufacturers who do not affix or imprint the product identifier to their packages until after November 26, 2018.
To learn more about the DSCSA drug tracing mandate or to get a free consultation on a drug tracing hardware and software solution, reach out to one of our Barcodes, Inc. representatives.
