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Prepping for DSCSA Compliance: A Comprehensive Timeline

The Drug Supply Chain Security Act (DSCSA) went into effect in 2015, but we’re only halfway to full implementation. The FDA’s 10-year plan creates an electronic, interoperable system for tracking and tracing prescription drugs in the U.S. health care supply chain and identifying and removing counterfeit drugs.

Phase II of the DSCSA will be implemented in 2023. It mandates complete unit-level traceability in the entire pharma supply chain. However, the next deadline will be here before the end of 2019.

Check out the entire DSCSA timeline and all the deadlines you must meet.

The DSCSA Timeline

January 1, 2015

Phase I of the DSCSA began by requiring all pharma manufacturers to print lot numbers on packaging for all prescription drugs.

November 27, 2018

Next, DSCSA required pharmaceutical manufacturers and re-packagers to include unique serial numbers and expiration dates on prescription drug packaging.

This information had to be in a human-readable format and in GS1 barcodes. But it also had to be included in 2D codes (Data Matrix Codes). Manufacturers and re-packagers also had to capture and store transaction information (TI), transaction history (TH), and transaction statements (TS) in their databases for at least six years.

November 27, 2019

This pending deadline affects pharma wholesalers, who must authenticate and verify prescription drugs before reselling them. They must only buy and sell products with serial numbers and the right barcodes, as well as capture TI, TH, and TS for creating proper documents for product tracking. They will also need to authenticate and verify saleable returns using the Verification Router Service (VRS).

November 27, 2020

This deadline will affect dispensers, who will also need to have processes in place to authenticate and verify all the medicines they buy before selling them to consumers. They will need to store all TI, TH, and TS data for product tracking and tracing.

November 27, 2023

By the end of 2023, the entire supply chain must be DSCSA compliant. Complete unit-level traceability, including aggregation, will be mandatory.

How to Meet the Upcoming DSCSA Deadlines

To be fully DSCSA compliant before a deadline, you need to have a proper system in place for exchanging information with your downstream trading partners.

You must make sure that every product you buy, sell, or resell contains a serial number, lot number, expiration date, and GS1 and 2D barcodes. You must also know exactly where all those products have been in the supply chain so you can identify potentially counterfeit, stolen, or harmful drugs and remove them from the supply chain.

This is why you need to capture TI, TH, and TS to achieve interoperability. By collecting and passing this information down the supply chain, you help protect consumers by ensuring only safe drugs remain in the supply chain.

To do all this, you need to utilize software solutions capable of meeting DSCSA serialization requirements and tracking and tracing products in your supply chain. rfxcel offers reliable and scalable track and trace software for increasing visibility in supply chains and achieving the full interoperability necessary for being DSCSA compliant.

Our software solutions can help you authenticate and verify products in the pharma supply chain, including VRS for saleable returns, as well as integrate aggregation. They can also help you collect and store all the necessary master data for achieving interoperability so you can take control of your supply chain and become fully DSCSA compliant.

If you need more information about the DSCSA timeline and compliance or how our traceability platform can help you support a safe supply chain, contact us today.

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