The clock is ticking. A worthy goal hangs in the balance as an impending timeline looms, testing the readiness of pharmaceutical companies across the country. This is about the aim of the FDA to better protect patients and make the supply chain more secure.
DSCSA 2023 Requirement
The Drug Supply Chain Security Act (DSCSA) was passed in 2013 in response to the danger of counterfeit drugs entering the prescription drug supply chain, affecting consumers and distributors. Since then, the FDA formulated a 15-step plan to implement the act. This meant imposing new standards across the pharmaceutical industry.
DSCSA implementation will culminate with a deadline of November 27, 2023, meaning we are now only two years away from the deadline. Specifically, the statutory components of the act that will go into effect in 2023 are:
- Interoperable Exchange
Trading Partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.
- Interoperable Verification
Trading partners must be able to verify the product identifier on a package in a secure, electronic, interoperable manner.
- Interoperable Tracing
Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it, and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.
Prior to these components going into effect, products are tracked by the lot. With the new standards in place, tracing can be done at the individual item level – resulting in far greater consumer protections.
Where Are We Now?
Patient safety is everyone’s responsibility. However, getting compliant with the FDA’s serialization standards is no easy task. In fact, it can be downright mind boggling. A recent poll by LSPediA in November 2021 showed that 43 percent of people in the industry had no solution to meet the 2023 compliance requirement. The same poll also showed juggling time, workload, and resources is a common challenge.
The average wholesale distributor has over 100 manufacturer suppliers, and the average manufacturer has 30 plus wholesale customers. Each connection and testing for Interoperable EPCIS Exchange between any two trading partners takes 4-8 weeks to complete. With only two years to go, the question is “Are you running out of runway?”
That is precisely why the big 3 wholesalers require their suppliers to complete EPCIS data exchange in 2022, in order to gain valuable time to acclimate and work out any problems.
“There’s just so much to do in the next two years, so it’s just imperative, I can’t underscore enough that manufacturers work proactively with distributors to send and stabilize the data over the next 12 months,” Jeff Falardeau, Manager of Pharmaceutical Information Technology at Cardinal Health, said during the recent Cardinal Health Workshop. “We need all our suppliers onboarded to EPCIS in 2022, so that we can shift our focus to our dispenser customers for the full interoperability in 2023.”
Clear The Runway With OneScan
The timeline for implementing the DSCSA provisions can be a real problem without the proper tools to tackle the issues. That’s where LSPediA and its innovative OneScan technology and Investigator solution can provide a pathway to a compliant future.
Trusted by hundreds of manufacturers and wholesale distributors, OneScan is the fastest growing DSCSA solution in the US. Coupled with rapid implementation, comprehensive solution capabilities, and high-performance computing, our customers use OneScan to make, move, and track serialized drug products. They use Investigator to manage any corresponding supply chain exceptions, resulting in 100% DSCSA compliance including the 2023 requirement.
With only two years left, you need enough speed to clear the end of a runway to mitigate compliance risk and business risk. I encourage you to discuss your current situation with us to find a business fit. To receive assistance from a LSPediA Representative, click here. To learn more about OneScan and Investigator, please visit https://www.lspedia.com.